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

NCT02486094 | Completed

• 1 other identifier: CCR 4324
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Colorectal Neoplasms; Rectal Diseases; Gastrointestinal Neoplasms

Keywords

Imaging, Magnetic Resonance; Rectal Cancer; Apoptosis; Proliferation; Cancer; Tissue Study

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Time to local recurrence

  At one and three years

• Disease Free Survival (DFS)

  At one and three years

• Overall Survival (OS)

  At one and three years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• No pre-operative radiotherapy
• Patients with synchronous tumours
• Patients under the age of 18 years

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• The Royal College of Surgeons of England: collaborator
• Croydon Health Services NHS Trust: collaborator

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pre-treatment biopsy and post surgical tissue

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms; Rectal Diseases; Gastrointestinal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Gina Brown

  Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 1, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: June 7, 2017
• Last Updated: June 12, 2017

Record last verified: 2015-06

Locations

GB (1)