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

Neoplasms Clinical Trial

— SOPRANO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486094
• Other study ID #: CCR 4324
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: June 9, 2017
• Start date: June 2015
• Est. completion date: June 7, 2017

Study information

• Verified date: June 2015
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: June 7, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms
• Rectal Diseases
• Rectal Neoplasms

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	Sutton	Surrey

Sponsors (3)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Croydon Health Services NHS Trust, The Royal College of Surgeons of England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Time to local recurrence		At one and three years
Secondary	Disease Free Survival (DFS)		At one and three years
Secondary	Overall Survival (OS)		At one and three years