Clinical trial NCT02486094: Study of PRoliferation and Apoptosis in Rectal Cancer, Predictive & Prognostic biOmarkers: Histopathology and Imaging
Official title: Study Of PRoliferation and Apoptosis in Rectal caNcer as Predictive and Prognostic biOmarkers: a Histopathology and Imaging Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Colorectal Neoplasms
Rectal Diseases
Gastrointestinal Neoplasms
Keywords: Imaging, Magnetic Resonance
Rectal Cancer
Apoptosis
Proliferation
Cancer
Tissue Study
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The Royal College of Surgeons of England
name: Croydon Health Services NHS Trust
First posted: 2015-07-01
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy
timeFrame: Tissue removed at diagnosis (approximately 15 weeks prior to surgery)
measure: Apoptotic index, Ki67 and Geminin in cells per mm cubed from resected tumour
timeFrame: Tissue removed during operation
Secondary outcomes:
measure: Time to local recurrence
timeFrame: At one and three years
measure: Disease Free Survival (DFS)
timeFrame: At one and three years
measure: Overall Survival (OS)
timeFrame: At one and three years
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden Hospital NHS Foundation Trust
name: Gina Brown
role: PRINCIPAL_INVESTIGATOR
References: