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

Royal Marsden NHS Foundation Trust148 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

148

Conditions

Neoplasms Colorectal Neoplasms Rectal Diseases Gastrointestinal Neoplasms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Marsden Hospital NHS Foundation Trust

Sutton, Surrey, United Kingdom

Outcomes

Primary Outcomes

Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy

Tissue biopsy taken at endoscopy to confirm cancer diagnosis is studied

Time frame: 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

Time frame: Tissue removed during operation

Secondary Outcomes

Time to local recurrence

Time frame: At one and three years

Disease Free Survival (DFS)

Time frame: At one and three years

Overall Survival (OS)

Time frame: At one and three years

Data from ClinicalTrials.gov

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