Development of a Clinical and Biological Database in Rectum Cancer

Rectal Neoplasms Clinical Trial

— BCBRectum  

Official title:

Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04006951
• Other study ID #: ICM-BCB-2014/02
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2014
• Est. completion date: December 2026

Study information

• Verified date: November 2021
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: BLEUSE Jean-Pierre, MD
• Phone: 4 67 61 31 00
• Email: jean-pierre.bleuse[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Other:
• Biological collection
Blood samples are collected at different times : Before any treatment After pre-operative radiochemotherapy and before surgery (if applicable)

Locations

Country	Name	City	State
France	ICM Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Until the study completion : 66 months