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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02486094
Acronym
SOPRANO
Enrollment
148
Registered
2015-07-01
Start date
2015-06-30
Completion date
2017-06-07
Last updated
2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms, Gastrointestinal Neoplasms, Neoplasms, Rectal Diseases

Keywords

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

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.

Interventions

None listed

Sponsors

The Royal College of Surgeons of England
CollaboratorOTHER
Croydon Health Services NHS Trust
CollaboratorOTHER
Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsyTissue removed at diagnosis (approximately 15 weeks prior to surgery)Tissue biopsy taken at endoscopy to confirm cancer diagnosis is studied
Apoptotic index, Ki67 and Geminin in cells per mm cubed from resected tumourTissue removed during operationTissue removed during surgery (to resect tumour) is studied

Secondary

MeasureTime frame
Time to local recurrenceAt one and three years
Disease Free Survival (DFS)At one and three years
Overall Survival (OS)At one and three years

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026