NCT02823860: BIG-RENAPE

Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies

Completed NA Last updated 19 December 2025

What this trial tests

NA trial testing Collection of biospecimens and Quality of Life (QoL) assessment in Digestive Peritoneal Carcinomatosis in 2,186 participants. Completed in 13 October 2022.

Timeline

12 February 2016

Primary endpoint
13 October 2022

13 October 2022

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	2,186
Start date	12 February 2016
Primary completion	13 October 2022
Estimated completion	13 October 2022
Sites	1 location across France

Drugs / interventions tested

• Collection of biospecimens and Quality of Life (QoL) assessment

Conditions studied

• Digestive Peritoneal Carcinomatosis — all drugs for Digestive Peritoneal Carcinomatosis →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Digestive Peritoneal Carcinomatosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The oncogenic and druggable hPG80 (Progastrin) is overexpressed in multiple cancers and detected in the blood of patients.
   You B, Mercier F, Assenat E, Langlois-Jacques C, et al · · 2020 · cited 16× · PMID 31877416 · DOI 10.1016/j.ebiom.2019.11.035
2. Risk of Omental Metastases in Patients Undergoing Cytoreductive Surgery for Colorectal Peritoneal Metastases.
   Bonnefoy I, Mohamed F, Bonnot PE, Benzerdjeb N, et al · · 2020 · cited 7× · PMID 32618618 · DOI 10.1097/dcr.0000000000001670
3. Patterns of peritoneal dissemination and response to systemic chemotherapy in common and rare peritoneal tumours treated by cytoreductive surgery: study protocol of a prospective, multicentre, observational study.
   Bhatt A, Rousset P, Baratti D, Biacchi D, et al · · 2021 · cited 4× · PMID 34226220 · DOI 10.1136/bmjopen-2020-046819
4. Progastrin: An Overview of Its Crucial Role in the Tumorigenesis of Gastrointestinal Cancers.
   Fioretzaki R, Sarantis P, Charalampakis N, Christofidis K, et al · · 2024 · cited 2× · PMID 38672239 · DOI 10.3390/biomedicines12040885
5. Correlation of Morphological Appearance of Peritoneal Lesions at Laparotomy and Disease at Pathological Assessment in Patients Undergoing Cytoreductive Surgery for Peritoneal Malignancy: Results of Phase I of the PRECINCT Study in 707 Patients.
   Bhatt A, Villeneuve L, Sardi A, Souadka A, et al · · 2024 · PMID 39187665 · DOI 10.1245/s10434-024-16035-9
6. Epidemiology of psychiatric disorders following cytoreductive surgeries plus hyperthermic intraperitoneal chemotherapy: a prospective cohort analysis.
   Economos G, Kepenekian V, Barbaret C, Villeneuve L, et al · · 2023 · PMID 37679494 · DOI 10.1038/s41598-023-42047-8