Clinical trial NCT02823860: Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies
Official title: Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive Peritoneal Carcinomatosis
Keywords: Peritoneal carcinomatosis
Biobanking
Biospecimen research
Prospective clinical database
Tissue banking
Quality of Life
various histological subtypes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 2186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Resistance to oncological treatments
timeFrame: During the 3-year follow-up
measure: Presence of biological and tumoral factors related to resistance to oncological treatments
timeFrame: During the 3-year follow-up
Secondary outcomes:
measure: Presence of clinical factors related to resistance to oncological treatments.
timeFrame: During the 3-year follow-up
measure: Incidence of recurrence and survival
timeFrame: at 3 years
measure: social characteristics of patients by MOS-SSS test, according to their therapeutic car modalities
timeFrame: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
measure: quality of life measured by questionnaires (composite measure composed of QLQ-C30, QLQ-CR29 and QLQ-STO22 questionnaires), according to treatment strategies
timeFrame: at baseline (day 0), 1 month post baseline (M1) 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
measure: Intensity of pain perceived by the patient measured by VAS scale
timeFrame: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
measure: Presence of epidemiological and demographic determinants of delayed access to treatment induction or surgical procedure
timeFrame: During the 3-year follow-up
measure: Presence of prognostic and predictive biomarkers related to resistance to oncological treatments .
timeFrame: During the 3-year follow-up
measure: behavioral characteristics of patients by HADS Scale, according to their therapeutic car modalities
timeFrame: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet - 69495 Pierre-Bénite, France
name: Olivier Glehen, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnefoy I, Mohamed F, Bonnot PE, Benzerdjeb N, Isaac S, Cotte E, Glehen O, Passot G. Risk of Omental Metastases in Patients Undergoing Cytoreductive Surgery for Colorectal Peritoneal Metastases. Dis Colon Rectum. 2020 Sep;63(9):1251-1256. doi: 10.1097/DCR.0000000000001670.
citation: Peron J, Mercier F, Tuech JJ, Younan R, Sideris L, Gelli M, Dumont F, Le Roy B, Sgarbura O, Lo Dico R, Bibeau F, Glehen O, Passot G; on behalf BIG-RENAPE working groups. The location of the primary colon cancer has no impact on outcomes in patients undergoing cytoreductive surgery for peritoneal metastasis. Surgery. 2019 Feb;165(2):476-484. doi: 10.1016/j.surg.2018.07.027. Epub 2018 Sep 7.