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

June 9, 2017 updated by: Royal Marsden NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with rectal cancer, diagnosed between 2011 and 2013, who have had an mrTRG score in a post-radiotherapy MRI scan.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

The Royal College of Surgeons of England
Croydon Health Services NHS Trust

Investigators

  • Principal Investigator: Gina Brown, Royal Marsden Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

June 7, 2017

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR 4324

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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