Clinical trial · Observational
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
NCT02486094CI-TRIAL-00028070SOPRANOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Rectal Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- 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)
- description
- Tissue biopsy taken at endoscopy to confirm cancer diagnosis is studied
- measure
- Apoptotic index, Ki67 and Geminin in cells per mm cubed from resected tumour
- timeFrame
- Tissue removed during operation
- description
- Tissue removed during surgery (to resect tumour) is studied
Secondary outcomes (3)
- measure
- Time to local recurrence
- timeFrame
- At one and three years
- measure
- Disease Free Survival (DFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.