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Development of a Clinical and Biological Database in Rectum Cancer (BCBRectum)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rectal Neoplasms | Other: Biological collection | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer |
| Actual Study Start Date : | October 8, 2014 |
| Estimated Primary Completion Date : | July 2021 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Biological collection
For all the patients include in the study :
In parallel to this biological collection, standardized clinical data will be entered into a database |
Other: Biological collection
Blood samples are collected at different times :
|
- 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
- Age > 18 years
- Signed informed consent
Exclusion Criteria:
- 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
| Contact: BLEUSE Jean-Pierre, MD | 4 67 61 31 00 ext +33 | jean-pierre.bleuse@icm.unicancer.fr |
| France | |
| ICM Val d'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Contact: BLEUSE Jean-pierre 00467613102 jean-pierre.bleuse@icm.unicancer.fr | |
| Study Chair: | ROUANET Philippe, MD-PhD | Institut régional du Cancer Montpellier |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 1, 2019 | ||||
| First Posted Date ICMJE | July 5, 2019 | ||||
| Last Update Posted Date | February 3, 2021 | ||||
| Actual Study Start Date ICMJE | October 8, 2014 | ||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Development of a Clinical and Biological Database in Rectum Cancer | ||||
| Official Title ICMJE | Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer | ||||
| Brief 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. | ||||
| 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 :
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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
||||
| Condition ICMJE | Rectal Neoplasms | ||||
| Intervention ICMJE | Other: Biological collection
Blood samples are collected at different times :
|
||||
| Study Arms ICMJE | Experimental: Biological collection
For all the patients include in the study :
In parallel to this biological collection, standardized clinical data will be entered into a database Intervention: Other: Biological collection
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
300 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 2025 | ||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04006951 | ||||
| Other Study ID Numbers ICMJE | ICM-BCB-2014/02 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | Institut du Cancer de Montpellier - Val d'Aurelle | ||||
| Study Sponsor ICMJE | Institut du Cancer de Montpellier - Val d'Aurelle | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
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| PRS Account | Institut du Cancer de Montpellier - Val d'Aurelle | ||||
| Verification Date | February 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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