Colorectal Report

Colorectal cancer This protocol contains standards and guidelines for the preparation of structured reports for colorectal cancer. It is not intended to apply to tumours of the appendix, small bowel and anus. Local excisions of colorectal carcinomas will be dealt with in a subsequent protocol. Synchronous primary tumours should have separate protocols recorded for each tumour.

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

The subject of the report. Usually, but not always, this is a patient. However diagnostic services also perform analyses on specimens collected from a variety of other sources.

The practitioner that holds legal responsibility for ordering the investigation.

The diagnostic service that is responsible for issuing the report.

Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

This is not necessarily the source of the atomic data items - it is the entity that takes responsibility for the clinical report.

Pre Analytic component - information collection prior to specimen receipt at laboratory.

This is just a group/section header and is not a result field.

All clinical information as documented on the request form must be recorded verbatim.

The operating surgeon name and contact details.

Presence or absence of a perforation.

If present, record the nature of perforation.

The type of perforation.

Whether a clinical obstruction is present or absent.

Anatomical location of the tumour from a given list.

For synchronous tumours indicate each other site.

Conditional on rectum being selected. Measured in cm for RCPA requirements.

Note : Synchronous tumours should be reported separately – this serves only to identify the presence of other synchronous tumours for which separate reports will be submitted.

Quantitative measurement of distance from anal verge.

Conditional on rectum being selected. Measured in cm for RCPA requirements.

Conditional on rectum being selected Note : Measured in cm by longstanding surgical convention.

The type of operation selected from a list.

Type of operation.

A code for the type of operation selected from a list.

Single selection value list. If other procedure(s) is selected, record type of procedure. If anterior resection is selected, record anterior resection type.

Type of procedure - other.

The type of anterior resection.

Single selection value list.

An indication of pre-operative radiotherapy.

Single selection value list. If yes, record type of course.

The type of course of pre-operative radiotherapy.

Surgeons opinion on the existence of local residual cancer postsurgery.

Involvement of adjacent organs.

An indication of whether a new primary cancer or a recurrence.

Single selection value list. If regional (local) recurrence or distant metastasis describe.

? If need to make an invariant due to the conditional statement.

Description of regional (local) recurrence or distant metastases.

The pathology accession number of the specimen must be recorded.

Other relevant details Any clinical information received in other communications from the requestor or other clinician should be recorded together with the source of that information.

Macroscopic findings.

This is just a group/section header and is not a result field.

The specimen length must be recorded. This and all other measurements in this protocol should be made in millimetres unless otherwise stated.

measurement in mm.

Query if measurements are in mm is international ie USA and query if this comment needs to be refined to AUS? Ditto for subsequent metric measurements. ***Meagan Judge response: USA may be in cm's for colorecatal, but internationally the measurement is in mm. Ditto - internationally all other measurements are in mm, unless otherwise stated.

The site of the tumour must be recorded. The determination of the site is based on the assessment by the pathologist and the information provided by the surgeon on the request form. The anatomical site of the tumour is relevant for the following reasons: - It provides correlation with previous investigations. - It indicates whether a non-peritonealised (circumferential) margin is likely to be present. - The natural history and treatment of rectal cancer differs significantly from colonic cancer. - It defines the presence of regional lymph nodes versus non-regional lymph nodes. Strictly the rectum is that part of the large bowel distal to the sigmoid colon and its upper limit is indicated by the end of the sigmoid mesocolon. Standard anatomical texts put this at the level of the 3rd sacral vertebra but it is generally agreed by surgeons that the rectum starts at the sacral promontory. It was agreed by an international expert advisory committee that any tumour whose distal margin is seen at 15 cm or less from the anal verge using a rigid sigmoidoscope should be classified as rectal. The pathologist can identify the upper end of the rectum as the point where the colonic taeniae coli merge to form a single external muscle layer.

The maximum tumour diameter must be recorded. - The prognostic significance of maximum tumour size is not established. - Tumour size must be recorded for correlation with subsequent microscopic examination and to allow correlation with imaging undertaken prior to surgery. - If possible, distinguish carcinoma from inflammatory changes, as the latter may account for a considerable volume of tumour in some cases.

measurement in mm.

The distance of the tumour to the nearer proximal or distal "cut end" margin must be recorded. - This is the measurement from the nearer cut end of the specimen and not the non-peritonealised (circumferential, radial) margin. - Tumour at a longitudinal margin has always been considered a poor prognostic feature but it occurs very rarely. The necessity of sampling this margin has therefore been questioned. It is essential to sample this margin and examine it histologically if the tumour is close to the margin (within 30 mm), or if the tumour is found by histology to have an exceptionally infiltrative growth pattern, to show extensive blood vascular or lymphatic permeation, or to be a signet ring, small cell or undifferentiated carcinoma. - If included, doughnuts must be embedded for histological examination. - The difficulty presented by staples is recognised. In this situation, it is important for blocks taken immediately adjacent to the line of staples along the plane of the staple line to be examined.

measurement in mm.

The distance of the tumour to the circumferential margin must be recorded. - This is the measurement to the nonperitonealised (ie the circumferential or radial) margin. - This measurement is useful for comparison with and validation of the microscopic measurement. - It is not only the continuous spread of the primary tumour that is important for this measurement, but also discontinuous spread in the form of lymph node metastases, extramural deposits, and tumour in vessels and lymphatics. Even if the main tumour appears ‘well clear’ of this margin, it is important to block the tissue between the nearest tumour edge and the nonperitonealised resection margin to ensure picking up any discontinuous areas of spread. It may be that the tissue has to be embedded in two or more sequential blocks but this margin must be well sampled. - This combined with the clinical and microscopic findings is used to define the R code status (see Chapter 5).

measurement in mm.

The presence or absence of tumour perforation must be recorded. - Perforation through the tumour into the peritoneal cavity is a well established adverse prognostic factor in colonic22 and rectal cancer.23 It is suggested that a block be taken from the area of perforation for histological confirmation. If perforation is present, then this is regarded as pT4 in the TNM staging system, regardless of other factors. - Perforation of the proximal bowel as a result of a distal obstructing tumour must not be recorded as tumour perforation, but should be noted. - It is important to distinguish, where possible, between perforation occurring at the time of surgery and perforation before surgery.

Single selection value list.

For rectal tumours the relationship of the tumour to the anterior peritoneal reflection must be recorded. - The anterior aspect of the rectum is covered by peritoneum down to the peritoneal reflection. On the posterior aspect the nonperitonealised margin extends upwards as a triangular shaped bare area containing the rectal arteries, which then continues up to the start of the sigmoid mesocolon. - The nonperitonealised margin is also known as the radial or circumferential resection margin. It consists of a ‘bare’ area of connective tissue at the surgical plane of excision that is not covered by serosa. Low rectal tumours will be completely surrounded by a non-peritonealised margin (the circumferential margin), while upper rectal tumours have a non-peritonealised margin posterolaterally and a peritonealised (serosal) surface anteriorly. Tumours below the peritoneal reflection have the highest rates of local recurrence.

Single selection value list. Conditional on rectum being selected in Tumour Site.

For rectal resections the intactness of the mesorectum must be recorded. - The prognosis of rectal carcinoma has significantly improved with the use of total mesorectal excision (TME). Gross pathological assessment of the intactness of the mesorectum has been shown to correlate with patient outcome. The intactness of the specimen is recorded as one of the following: - Incomplete: little bulk to the rectum, defects in the mesorectum down to the muscularis propria, after transverse sectioning the circumferential margin appears very irregular. - Nearly complete: moderate bulk to the mesorectum, irregularity of the mesorectal surface with defects greater than 5 mm but none extending to the muscularis propria, no areas of visibility of the muscularis propria except at the insertion site of the levator ani muscles. - Complete: Intact bulky mesorectum with a smooth surface, only minor irregularities of the mesorectal surface, no surface defects greater than 5 mm in depth, no coning towards the distal margin of the specimen, after circumferential sectioning the circumferential margin appears smooth.

Single selection value list. Conditional on rectum being selected in Tumour Site.

Any involvement of the peritoneum should be recorded. This should be recorded as one of the following : - Tumour invades to the peritoneal surface - Tumour has formed nodule(s) discrete from the tumour mass along the serosal surface Tumour involvement of the serosa discontinuous from the site of the main tumour is to be recorded as a metastasis.

Single selection value list.

If lymph nodes are received, then they should be recorded.

Conditional: If received, record the number of nodes.

The number of lymph nodes placed in each cassette should be recorded.

The RCPA require the following be recorded: "Numeric: in cassette: " Query how to record this?

The number, diameter and gross configuration of polyps should be summarised. The pathologist should be cognisant of the presence of polyposis syndromes. These include: - Familial Adenomatous Polyposis (FAP) - Serrated - MutYH - Juvenile - Peutz–Jeghers At the present time the criteria for hyperplastic (serrated) polyposis syndrome: 1. At least five histologically confirmed hyperplastic (serrated) polyps proximal to the sigmoid colon, of which two are greater than 1 cm in diameter 2. Any number of hyperplastic (serrated) polyps proximal to the sigmoid colon in a subject with a first-degree relative with hyperplastic polyposis 3. More than 20 hyperplastic (serrated) polyps of any size distributed evenly throughout the colon.

Conditional: If present, provide a polyp summary.

The polyp summary should include the numbers, diameter range and gross appearance.

A descriptive or narrative field should be provided to record any macroscopic information that is not recorded in the above standards and guidelines, and that would normally form part of the macroscopic description.

The nature and sites of all blocks must be recorded.

Microscopy of the sample.

This is just a group/section header and is not a result field.

The tumour type must be recorded. A single selection value list from WHO Classification of Tumours. The description must be based on the WHO Histological Classification of Tumours of the Colon and Rectum (refer to Appendix 4).8 This publication, as well as a current version of the American Joint Commission on Cancer (AJCC) Cancer Staging Manual9 should be readily accessible to the reporting pathologist.

Single selection value list from WHO Classification of Tumours. Pathology and Genetics of Tumours of the Digestive System (2010).

How to represent this result group which has heading and components cf the bindings file is a flat file??

The histological grading of the tumour must be recorded.

Single selection value list.

The maximum degree of local invasion into or through the bowel wall must be recorded. This is based on the T component of the TNM staging system, as outlined in the AJCC Cancer Staging Manual.

Single selection value list.

Involvement of the proximal or distal resection margins (cut-end margins) by tumour must be recorded. If the margin is less than 10 mm, the clearance must be recorded.

Single selection value list. If involved is selected, record involved margin(s) If not involved is selected, record microscopic clearance.

Involvement of the proximal or distal resection margins (cut-end margins) by tumour must be recorded. If the margin is less than 10 mm, the clearance must be recorded.

Multi select value list (select all that apply). This is a conditional field.

If the margin is less than 10 mm, the clearance must be recorded.

Numeric: ___mm (if the margin is less than 10 mm) OR Clearance is ≥10mm.

Query how to achieve this??

The status of the nonperitonealised circumferential margin in rectal tumours must be recorded. - In rectal tumours, the minimum distance in millimetres between the tumour and the nonperitonealised (circumferential, radial) margin must be recorded from the histological slides. - Rectal tumours frequently (5–36%) involve the nonperitonealised surgical circumferential resection margin (CRM) and this is associated with significantly higher rates of local recurrence and cancer-related death.

Single selection value list. Conditional on rectum being selected in S2.02 If not involved is selected, record microscopic clearance.

In rectal tumours, the minimum distance in millimetres between the tumour and the nonperitonealised (circumferential, radial) margin must be recorded from the histological slides.

Is conditional.

Results of lymph node histopathology must be recorded. - The finding of positive lymph nodes is a major determinant of whether the patient receives adjuvant therapy. The probability of finding a positive node increases with the number of nodes found. Although this probability curve flattens out after finding 12–15 nodes, all identified lymph nodes must be microscopically examined. In general, a minimum of 10-12 lymph nodes should be identified and examined.

Single selection value list. Conditional on nodes being received in G2.02. If G2.02 has been recorded as “not received” this standard is not required. If present, record site(s) and number of lymph nodes.

If lymph node(s) received then the site(s) and numbers of lymph nodes must be recorded.

The site(s) of the lymph nodes must be recorded.

Number of positive nodes from this site.

Total number of nodes from this site.

The presence or absence of isolated extra-mural tumour deposits is to be recorded.

Single selection value list.

Involvement of the apical lymph node should be recorded, if required where staging systems additional to TNM staging are in use. Both the Australian Clinicopathological Staging System and the Dukes staging system are in use in some institutions in Australasia. These require the status of the apical lymph node to be recorded.

Single selection value list.

For all tumours, venous and small vessel invasion must be reported and its anatomic location specified as intramural or extramural. - Venous invasion by tumour has been repeatedly shown by multivariate and univariate analyses to be a stage independent adverse prognostic factor. However some studies identifying venous invasion as an adverse factor on univariate analysis have failed to confirm its independent impact on prognosis on multivariate breakdown. Similar disparate results have also been reported for lymphatic invasion. In other reports, vascular invasion as a general feature was prognostically significant, but no distinction between lymphatic and venous vessels was made. In a few studies the location as well as the type of the involved vessels (eg extramural veins) were both considered strong determinants of prognostic impact. Data from the many studies are difficult to amalgamate but nevertheless, the importance of venous and small vessel (lymphovascular) invasion by tumour is generally accepted, and it is considered that venous and small vessel invasion must be sought and separately recorded.

This is just a header and is not a data field ?? How to be entered in the resource.

Intramural invasion must be reported on.

Single selection value list.

Extramural invasion must be reported on.

Single selection value list.

Small vessel invasion must be reported on.

Single selection value list.

Perineural invasion should be assessed using routine histology and reported. - There is some evidence that perineural infiltration by tumour is an important indicator of spread, particularly in rectal tumours where it may involve the sacral plexus and this may be an indication for radiotherapy.

Single selection value list.

The presence or absence of histologically confirmed distant metastases must be recorded. - Disease classifiable as distant metastasis may sometimes be present within the primary tumour resection specimen (eg a serosal or mesenteric or greater omental deposit that is distant from the primary tumour mass). - Metastatic deposits in lymph nodes distant from those surrounding the main tumour or its main artery in the specimen will usually be submitted separately by the surgeon. Metastatic deposits in lymph nodes distant from the tumour or its main artery (ie nonregional nodes) may be seen in extended colectomy specimens and are regarded as distant metastases (pM1).

Single selection value list. If present, record sites.

The site of histologically confirmed distant metastases must be recorded.

Is conditional.

The relevant coexistent pathological abnormalities must be recorded.

Multi select value list (select all that apply). ?? How is this indicated?? If Polyps is selected provide details If Ulcerative colitis or Crohn’s disease is selected record dysplasia If other is selected, provide details in “other abnormality”.

The presence of any relevant coexistent pathological abnormalities in the bowel must be recorded. - The presence of polyps (type, number, and whether having the criteria of a polyposis syndrome), presence and type of chronic inflammatory bowel disease, with or without dysplasia, and any other clinically relevant pathology is important information that needs to be recorded.

Multi select value list (select all that apply). ?? How is this indicated?? If Polyps is selected provide details If Ulcerative colitis or Crohn’s disease is selected record dysplasia If other is selected, provide details in “other abnormality”.

The relevant coexistent pathological abnormalities (other abnormalities) must be recorded.

The polyp details (type, number, polyposis syndrome criteria met etc) is to be recorded.

Is conditional.

If Ulcerative colitis or Crohns disease is selected for relevant coexistent pathological abnormalities record dysplasia.

Single selection value list. Is conditional.

Cannot have an apostrophe in a spreadsheet eg Crohn apostrophe s.

Record any other abnormality.

The microscopic residual tumour status (completeness of resection) is to be recorded.

The response to neoadjuvant therapy should be recorded.

Other Microscopic comments should be recorded.

Ancillary test findings are to be recorded.

Immunohistochemical stains for microsatellite instability will be performed and a supplementary report issued.

This is just a group/section header and is not a result field, but some example reports this field was used as a comment field.

MLH-1 testing.

Single selection value list.

PMS-2 testing.

Single selection value list.

MSH-2 testing.

Single selection value list.

MSH-6 testing.

Single selection value list.

Mismatch repair enzyme comments can be recorded.

Microsatellite instability (MSI) to be recorded.

Single selection value list. If unstable or stable, record laboratory performing test and report number.

This is just a group/section header and is not a result field.

Microsatellite instability (MSI) to be recorded.

Microsatellite instability (MSI) comments can be recorded.

Conditional.

Microsatellite instability (MSI) laboratory performing test and report number can be recorded.

Conditional.

BRAF (V600E mutation) testing.

Single selection value list. If mutated or wild type, record laboratory performing test and report number.

This is just a group/section header and is not a result field.

BRAF (V600E mutation) testing.

BRAF (V600E mutation) comments can be recorded.

BRAF (V600E mutation) laboratory performing test and report number can be recorded.

KRAS gene mutation (codons 12 and 13) testing should be recorded. - Testing for the presence of mutations in the KRAS gene is typically requested by the clinician when metastatic disease is present. Therefore, such testing will most often be performed after the colorectal resection. In this situation, the result should be appended to the initial pathology report.

This is just a group/section header and is not a result field.

KRAS gene mutation (codons 12 and 13) testing.

KRAS gene mutation (codons 12 and 13) comments can be recorded.

KRAS gene mutation (codons 12 and 13) laboratory performing test and report number can be recorded.

Synthesis and Overview are to be recorded.

This is just a group/section header and is not a result field.

Tumour stage T is to be recorded.

Single selection value list.

Tumour stage N is to be recorded.

Single selection value list.

Tumour stage M is to be recorded.

Single selection value list.

Tumour stage grouping is to be recorded.

Single selection value list.

Check the formatting of the result group.

Year and/or edition of staging system is to be recorded.

Numeric: year AND/OR Text: Edition eg 1st, 2nd etc.

The residual tumour status must be recorded according to the AJCC Cancer Staging Manual (7th Edition).

The ‘Diagnostic summary’ section of the final formatted report should include: a. specimen type (S1.02) b. tumour site (S2.02) c. tumour type (S3.01) d. tumour stage (S5.01) e. completeness of excision (S5.03).

Include: a. specimen type b. tumour site c. tumour type d. tumour stage e. completeness of excision.

Record if this is a new primary cancer or a recurrence of a previous cancer, if known.

Single selection value list. If regional (local) recurrence or distant metastasis describe.

Description of regional (local) recurrence or distant metastases.

Conditional.

Synthesis and overview overarching comment This field may be used, for example, to: - list any relevant ancillary tests - document any noteworthy adverse gross and/or histological features - express any diagnostic subtlety or nuance that is beyond synoptic capture - document further consultation or results still pending. Use of this field is at the discretion of the reporting pathologist.

Conditional.