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

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ClinicalTrials.gov Identifier: NCT02823860
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Digestive Peritoneal Carcinomatosis Other: Collection of biospecimens and Quality of Life (QoL) assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies
Actual Study Start Date : February 12, 2016
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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


  2. 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



Secondary Outcome Measures :
  1. 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.

  2. Incidence of recurrence and survival [ Time Frame: at 3 years ]
    Impact of therapeutics strategies on the incidence of recurrence and survival

  3. 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).

  4. 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.


  5. 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).

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823860


Contacts
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Contact: Peggy Jourdan Enfer (0) 478 864 534 ext +33 peggy.jourdan-enfer@chu-lyon.fr
Contact: Laurent Villeneuve (0) 478 864 536 ext +33 laurent.villeneuve@chu-lyon.fr

Locations
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France
Centre Hospitalier Lyon Sud Recruiting
Pierre Bénite, France, 69495
Contact: Olivier GLEHEN, Pr    +33(0)478861377    olivier.glehen@chu-lyon.fr   
Principal Investigator: Olivier Glehen, PU-PH         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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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

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02823860     History of Changes
Other Study ID Numbers: 69HCL14_0345
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

Keywords provided by Hospices Civils de Lyon:
Peritoneal carcinomatosis
Biobanking
Biospecimen research
Prospective clinical database
Tissue banking
Quality of Life
various histological subtypes

Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases