Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies (BIG-RENAPE)

December 19, 2023 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre Bénite, France, 69495
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Biospecimens and Quality of Life (QoL)
Only if patient's consent is obtained, biospecimens, including tumor and/or peripheral blood are collected.
Other: Collection of biospecimens and Quality of Life (QoL) assessment
Serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE). Biospecimens are collected at various stages of diagnostic and therapeutic care.All patients fill out questionnaires of Health related quality of life (QLQ-C30 + QLQ-CR29/STO22, Hospital Anxiety and Depression scale - HAD) and social-demographic survey (Medical Outcome Studies - Social Support Survey- MOS-SSS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistance to oncological treatments
Time Frame: During the 3-year follow-up

Resistance to treatments (systemic and intraperitoneal chemotherapy, surgical procedures and targeted therapies) in patients treated for digestive peritoneal carcinomatosis is defined as a change of therapeutic strategy decided during a multidisciplinary meeting.

The biological and tumoral factors related to resistance of oncological treatments will be identified from the laboratory tests results and histological analyses.

Biospecimens types: serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE).

Biospecimens are collected at various stages of diagnostic and therapeutic care
During the 3-year follow-up
Presence of biological and tumoral factors related to resistance to oncological treatments
Time Frame: During the 3-year follow-up

The biological and tumoral factors related to resistance of oncological treatments will be identified from the laboratory tests results and histological analyses.

Biospecimens types: serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE).

Biospecimens are collected at various stages of diagnostic and therapeutic care The biological and tumoral factors related to resistance of oncological treatments will be identified from the laboratory tests results and histological analyses.

Biospecimens types: serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE).

Biospecimens are collected at various stages of diagnostic and therapeutic care
During the 3-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of clinical factors related to resistance to oncological treatments.
Time Frame: During the 3-year follow-up
Demographic, pathological, clinical information are recorded electronically on a secured Web application and linked to biospecimens identification.
During the 3-year follow-up
Incidence of recurrence and survival
Time Frame: at 3 years
Impact of therapeutics strategies on the incidence of recurrence and survival
at 3 years
social characteristics of patients by MOS-SSS test, according to their therapeutic car modalities
Time Frame: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
The Medical Outcomes Study Social Support Survey (MOS-SSS) is used as a self-administered measure of functional social support for chronically ill persons. The 19 items cover four domains (emotional/informational support, tangible support, positive social interaction, and affection).
at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
quality of life measured by questionnaires (composite measure composed of QLQ-C30, QLQ-CR29 and QLQ-STO22 questionnaires), according to treatment strategies
Time Frame: at baseline (day 0), 1 month post baseline (M1) 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months

The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.

The QLQ-CR29 was administered with the QLQ-C30 core questionnaire. It is meant for use among colorectal cancer patients varying in disease stage and treatment modality. The module comprises 29 questions assessing the colorectal cancer-specific symptom scales (disease symptoms, side effects of treatment) and functional scales (body image, sexuality, and future perspective).

The QLQ-STO22 was administered with the QLQ-C30 core questionnaire. The QLQ-STO22 module contains 22 items regarding dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss.
at baseline (day 0), 1 month post baseline (M1) 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
Intensity of pain perceived by the patient measured by VAS scale
Time Frame: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
The patient's perception intensity of pain is measured with a Visual Analogue Scale (VAS).
at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
Presence of epidemiological and demographic determinants of delayed access to treatment induction or surgical procedure
Time Frame: During the 3-year follow-up
Epidemiological and demographic factors will be assessed from the prospective and clinical database.
During the 3-year follow-up
Presence of prognostic and predictive biomarkers related to resistance to oncological treatments .
Time Frame: During the 3-year follow-up
The prognostic and predictive biomarkers related to resistance of oncological treatments will be identified from the biological tumoral and clinical data.
During the 3-year follow-up
behavioral characteristics of patients by HADS Scale, according to their therapeutic car modalities
Time Frame: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months
The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, is used to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.
at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Olivier Glehen, Pr, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet - 69495 Pierre-Bénite, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2016

Primary Completion (Actual)

October 13, 2022

Study Completion (Actual)

October 13, 2022

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimated)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL14_0345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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