Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies (BIG-RENAPE)
Status
Conditions
Treatments
Details and patient eligibility
About
To access to good quality biological samples is a prerequisite for high level translational research. The BIG-RENAPE study has been established by the French hyperthermic intraperitoneal chemotherapy centers involved in the management of peritoneal surface malignancies.
The main BIG-RENAPE study aim is to create a large multicentric and prospective repository for biological and tissue samples, which will provide a source of materials for a wide array of health related research studies - BIG-RENAPE Biobank-based research: i) validating known and promising biomarkers; ii) identifying new predictive and prognostic factors; iii) evaluating the impact of current health care strategies; iv) standardizing diagnostic and therapeutic management through guidelines; v) developing new drugs.
The BIG-RENAPE Biobank is certified according to NFS 96-900 as a service of processing, storage and transfer of high quality biological (plasma, serum, buffy coat) and tissue (formalin-fixed-paraffin-embedded) samples. Biospecimens are collected at each stage of diagnostic and therapeutic care. The patient and his derivates are anonymized and registered in a national web database reporting disease status, treatments, surgical procedures, pathological diagnosis, quality of life's assessment and long term follow-up. All participants have given their informed consent before any sample. The BIG-RENAPE study was approved by the local Ethical Committee, based on the assessed compliance to French regulatory rules.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Men / women aged over 18 years
- Patients with cancer management and care for peritoneal carcinomatosis of digestive origin
- Patients had histologic/radiologic confirmation of peritoneal disease
- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research;
- Ability of participants to give their informed consent
Exclusion criteria
- Minor patient
- Adult unable to consent
- Patient refusal to participate in the study
Trial design
Primary purpose
Allocation
Interventional model
Masking
2,186 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Peggy Jourdan Enfer; Laurent Villeneuve
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal