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

NCT ID: NCT02486094

Last Updated: 2017-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-07

Brief Summary

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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

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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.

Conditions

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Neoplasms Colorectal Neoplasms Rectal Diseases Gastrointestinal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Royal College of Surgeons of England

OTHER

Sponsor Role collaborator

Croydon Health Services NHS Trust

OTHER

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gina Brown

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden Hospital NHS Foundation Trust

Locations

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Royal Marsden Hospital NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CCR 4324

Identifier Type: -

Identifier Source: org_study_id

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