Rectal NeoplasmsBCBRectumNCT04006951
Development of a Clinical and Biological Database in Rectum Cancer
A study testing Biological collection in people with Rectal Neoplasms, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Biological collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2014to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
- Age > 18 years
- Signed informed consent
Who cannot join
- Patient not affiliated to Social Protection system
- Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
- Patient under guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ICM Val d'Aurelle
Montpellier, 34298
Philippe ROUANET, 00467613100, philippe.rouanet@icm.unicancer.fr
About this study
Official title: Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer
A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.
Read the detailed description
In France, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. Rectal carcinoma represents 40% of colorectal cancers.
Locally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. Currently, pre-operative radiochemotherapy associated with radical proctectomy (TME) is the standard treatment. Radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results.
Moreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%.
Then, compliance to adjuvant chemotherapy is generally poor after radical proctectomy.
Tumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. Nevertheless, at present, there are no predictive markers of tumor response.
Progresses in rectal cancer management are related to sharing biological and clinical resources with scientific community.
A clinical and biological collection will allow to :
- develop research programs on predictive markers to pre-operative radiochemotherapy or prognostics factors to disease recurrence
- optimize diagnostic and follow-up tests
- develop new biomarkers to improve patient's therapeutic management
In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection biomedical research dedicated to the tissular and blood samples of patients with colorectal cancer.
- Conditions
- Rectal Neoplasms
- Being tested
- Biological collection
- Keywords
- Cancer, Colorectal cancer, Biological Specimen Banks
- Medical subject headings
- Rectal Neoplasms, Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionOther
Blood samples are collected at different times :
- Before any treatment
- After pre-operative radiochemotherapy and before surgery (if applicable)
| Study group | Role | What they receive |
|---|---|---|
| Biological collection | Experimental | For all the patients include in the study :
* Paraffin tissue samples (if applicable) collected during pre-therapeutic rectal biopsy
* Blood samples collected at different times : Before any treatment and Before surgery if the patient received pre-operative radiochemotherapy
In parallel to this biological collection, standardized clinical data will be entered into a database Receives: Other: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who gave their consent to participate in the study
The proportion of patients who consent to participate in the study among the screened patients
Measured: Until the study completion : 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start8 Oct 2014
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROUANET Philippe, MD-PhD, Study chair, Institut régional du Cancer Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006951
- Sponsor's protocol ID
- ICM-BCB-2014/02
- Acronym
- BCBRectum
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haustermans K, Debucquoy A, Lambrecht M. The ESTRO Breur Lecture 2010: toward a tailored patient approach in rectal cancer. Radiother Oncol. 2011 Jul;100(1):15-21. doi: 10.1016/j.radonc.2011.05.024. Epub 2011 May 31.
PubMed 21632132
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer
- ClinicalTrials.gov ID
- NCT04006951
- Acronym / sponsor ID
- BCBRectum / ICM-BCB-2014/02
- Conditions
- Rectal Neoplasms
- Keywords
- Cancer, Colorectal cancer, Biological Specimen Banks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 8 Oct 2014 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jul 2019 (actual)
- 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.
A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.
Detailed description
In France, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. Rectal carcinoma represents 40% of colorectal cancers.
Locally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. Currently, pre-operative radiochemotherapy associated with radical proctectomy (TME) is the standard treatment. Radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results.
Moreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%.
Then, compliance to adjuvant chemotherapy is generally poor after radical proctectomy.
Tumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. Nevertheless, at present, there are no predictive markers of tumor response.
Progresses in rectal cancer management are related to sharing biological and clinical resources with scientific community.
A clinical and biological collection will allow to :
- develop research programs on predictive markers to pre-operative radiochemotherapy or prognostics factors to disease recurrence
- optimize diagnostic and follow-up tests
- develop new biomarkers to improve patient's therapeutic management
In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection biomedical research dedicated to the tissular and blood samples of patients with colorectal cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological collection | Experimental | Other: Biological collectionFor all the patients include in the study : * Paraffin tissue samples (if applicable) collected during pre-therapeutic rectal biopsy * Blood samples collected at different times : Before any treatment and Before surgery if the patient received pre-operative radiochemotherapy In parallel to this biological collection, standardized clinical data will be entered into a database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
- Age > 18 years
- Signed informed consent
Key exclusion criteria (3 listed)
- Patient not affiliated to Social Protection system
- Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological collectionBlood samples are collected at different times : * Before any treatment * After pre-operative radiochemotherapy and before surgery (if applicable) | Other | Biological collection |
Primary outcome
Proportion of patients who gave their consent to participate in the study
Time frame: Until the study completion : 66 months
The proportion of patients who consent to participate in the study among the screened patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 21632132Haustermans K, Debucquoy A, Lambrecht M. The ESTRO Breur Lecture 2010: toward a tailored patient approach in rectal cancer. Radiother Oncol. 2011 Jul;100(1):15-21. doi: 10.1016/j.radonc.2011.05.024. Epub 2011 May 31.
- Individual participant dataSharing planned: No
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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.
ROUANET Philippe, MD-PhD study chair
Institut régional du Cancer Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological collection in people with Rectal Neoplasms, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 3 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore MOUSSION (4 67 61 31 02 ext. +33, drci-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who gave their consent to participate in the study (time frame: Until the study completion : 66 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006951, which also lists 1 linked publication.
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 13 Feb 2025.