Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT04006951
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2019-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Clinical and Biological Database in Rectum Cancer
Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Organization:
Study Overview
Official Title:
Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCBRectum
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 :
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: