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Development of a Clinical and Biological Database in Rectum Cancer

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04006951
Acronym
BCBRectum
Enrollment
300
Registered
2019-07-05
Start date
2014-10-08
Completion date
2026-12-31
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

Keywords

Cancer, Colorectal cancer, Biological Specimen Banks

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.

Interventions

OTHERBiological collection

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

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients who gave their consent to participate in the studyUntil the study completion : 66 monthsThe proportion of patients who consent to participate in the study among the screened patients

Countries

France

Contacts

Primary ContactAurore MOUSSION
drci-icm105@icm.unicancer.fr4 67 61 31 02

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026