Skip to main content
OpenTrials
Completed

NCT Number: NCT02486094

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Marsden Hospital NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Time to local recurrence

    Time frame: At one and three years

  2. Disease Free Survival (DFS)

    Time frame: At one and three years

  3. Overall Survival (OS)

    Time frame: At one and three years

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SOPRANO

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 1, 2015
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.