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CompletedNCT02486094SOPRANOUpdated Jun 12, 2017

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

An observational study in Neoplasms, Colorectal Neoplasms and Rectal Diseases, sponsored by Royal Marsden NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-12.

Sponsored by Royal Marsden NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
148
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Neoplasms
  • Colorectal Neoplasms
  • Rectal Diseases
  • Gastrointestinal Neoplasms

Keywords

  • Imaging, Magnetic Resonance
  • Rectal Cancer
  • Apoptosis
  • Proliferation
  • Cancer
  • Tissue Study
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 148 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
148 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy

    Tissue biopsy taken at endoscopy to confirm cancer diagnosis is studied

    Time frame: Tissue removed at diagnosis (approximately 15 weeks prior to surgery)

  2. Apoptotic index, Ki67 and Geminin in cells per mm cubed from resected tumour

    Tissue removed during surgery (to resect tumour) is studied

    Time frame: Tissue removed during operation

Secondary outcomes

  1. Time to local recurrence

    Time frame: At one and three years

  2. Disease Free Survival (DFS)

    Time frame: At one and three years

  3. Overall Survival (OS)

    Time frame: At one and three years

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Study locations

1 site
  • Royal Marsden Hospital NHS Foundation Trust
    Sutton, Surrey SM2 5PT, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02486094
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborators
The Royal College of Surgeons of England, Croydon Health Services NHS Trust
Responsible party
Sponsor
First posted
Jul 1, 2015
Start date
Jun 2015
Primary completion
Sep 1, 2016
Completion
Jun 7, 2017
Last update
Jun 12, 2017

Study contacts

Gina Brown
principal investigator · Royal Marsden Hospital NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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