Study of PRoliferation and Apoptosis in Rectal Cancer, Predictive & Prognostic biOmarkers: Histopathology and Imaging

Study Overview
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Brief Summary
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This study tests biopsy and tissue from patients who have been treated for primary rectal cancer at the Royal Marsden Hospital between 2011 and 2013, who have an mrTRG score at post-chemoradiotherapy MRI. It is a retrospective pilot study to determine the apoptotic and proliferative index count pre and post chemoradiotherapy.

Detailed Description
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The investigators hope to validate the apoptotic and proliferative index as a predictive response marker and lend support to mrTRG as a putative prognostic tool in the treatment pathway for rectal cancer patients. Even though this is a retrospective study, the investigators hope that pre-treatment apoptotic and proliferative scores will correlate to post treatment response and mrTRG scores. In doing so, the investigators can predict how patients will respond to treatment from initial diagnostic biopsies and foresee a patients individual treatment plan.

Official Title
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Study Of PRoliferation and Apoptosis in Rectal caNcer as Predictive and Prognostic biOmarkers: a Histopathology and Imaging Analysis

Conditions
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Neoplasms, Colorectal Neoplasms, Rectal Diseases, Gastrointestinal Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age. Patients with primary adenocarcinoma of the rectum (diagnosed on tissue biopsy and disease spread assessed on CT and MRI). Tumours must be considered sufficiently high-risk to require pre-operative chemoradiotherapy followed by surgery. Patients must have had a pre- and post-treatment MRI scan of the rectum and pelvis. We must have access to stored tissue for each patient Exclusion Criteria: No pre-operative radiotherapy Patients with synchronous tumours Patients under the age of 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy | Tissue biopsy taken at endoscopy to confirm cancer diagnosis is studied | Tissue removed at diagnosis (approximately 15 weeks prior to surgery) | 
| Apoptotic index, Ki67 and Geminin in cells per mm cubed from resected tumour | Tissue removed during surgery (to resect tumour) is studied | Tissue removed during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to local recurrence |  | At one and three years | 
| Disease Free Survival (DFS) |  | At one and three years | 
| Overall Survival (OS) |  | At one and three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imaging, Magnetic Resonance, Rectal Cancer, Apoptosis, Proliferation, Cancer, Tissue Study