NeoplasmsSOPRANONCT02486094
Study of PRoliferation and Apoptosis in Rectal Cancer, Predictive & Prognostic biOmarkers: Histopathology and Imaging
An observational study of Neoplasms and Colorectal Neoplasms, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Colorectal Neoplasms, Rectal Diseases
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to 7 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rectal cancer, diagnosed between 2011 and 2013, who have had an mrTRG score in a post-radiotherapy MRI scan.
Who may be able to join
- 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
Who cannot join
- No pre-operative radiotherapy
- Patients with synchronous tumours
- Patients under the age of 18 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden Hospital NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Study Of PRoliferation and Apoptosis in Rectal caNcer as Predictive and Prognostic biOmarkers: a Histopathology and Imaging Analysis
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.
- Keywords
- Imaging, Magnetic Resonance, Rectal Cancer, Apoptosis, Proliferation, Cancer, Tissue Study
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Rectal Diseases, Gastrointestinal Neoplasms, Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy
Tissue biopsy taken at endoscopy to confirm cancer diagnosis is studied
Measured: Tissue removed at diagnosis (approximately 15 weeks prior to surgery)
Apoptotic index, Ki67 and Geminin in cells per mm cubed from resected tumour
Tissue removed during surgery (to resect tumour) is studied
Measured: Tissue removed during operation
Secondary outcomes (3)
Time to local recurrence
Measured: At one and three years
Disease Free Survival (DFS)
Measured: At one and three years
Overall Survival (OS)
Measured: At one and three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2015
- Primary completion1 Sep 2016
- Study completion7 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Surgeons of England, Croydon Health Services NHS Trust
- Responsible party
- Sponsor
- Investigators
- Gina Brown, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486094
- Sponsor's protocol ID
- CCR 4324
- Acronym
- SOPRANO
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2015
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of PRoliferation and Apoptosis in Rectal caNcer as Predictive and Prognostic biOmarkers: a Histopathology and Imaging Analysis
- ClinicalTrials.gov ID
- NCT02486094
- Acronym / sponsor ID
- SOPRANO / CCR 4324
- Keywords
- Imaging, Magnetic Resonance, Rectal Cancer, Apoptosis, Proliferation, Cancer, Tissue Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- The Royal College of Surgeons of England, Croydon Health Services NHS Trust
- Study start
- Jun 2015
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rectal cancer, diagnosed between 2011 and 2013, who have had an mrTRG score in a post-radiotherapy MRI scan.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- No pre-operative radiotherapy
- Patients with synchronous tumours
- Patients under the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy
Time frame: Tissue 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 tumour
Time frame: Tissue removed during operation
Tissue removed during surgery (to resect tumour) is studied
3 secondary outcomes
Time to local recurrence
Time frame: At one and three years
Disease Free Survival (DFS)
Time frame: At one and three years
Overall Survival (OS)
Time frame: At one and three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Brown principal investigator
Royal Marsden Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Colorectal Neoplasms, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy (time frame: Tissue removed at diagnosis (approximately 15 weeks prior to surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.