Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies
NCT ID: NCT02823860
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2186 participants
INTERVENTIONAL
2016-02-12
2022-10-13
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Biospecimens and Quality of Life (QoL)
Only if patient's consent is obtained, biospecimens, including tumor and/or peripheral blood are collected.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* Adult unable to consent
* Patient refusal to participate in the study
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Olivier Glehen, Pr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet - 69495 Pierre-Bénite, France
Locations
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Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
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References
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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.
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.
Other Identifiers
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69HCL14_0345
Identifier Type: -
Identifier Source: org_study_id