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

Completed

• Conditions: Colorectal Neoplasms; Gastrointestinal Neoplasms; Neoplasms; Rectal Diseases

• Registration Number: NCT02486094
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

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

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 Timeline

• Status Verified: 2015-06
• Study Start: 2015-06
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-07-01
• Primary Completion: 2016-09-01
• Study Completion: 2017-06-07
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to local recurrence	At one and three years
Overall Survival (OS)	At one and three years
Disease Free Survival (DFS)	At one and three years

Trial Locations

Locations (1)

Royal Marsden Hospital NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom