Digestive Peritoneal Carcinomatosis Clinical Trial
— BIG-RENAPEOfficial title:
Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies
| Verified date | December 2023 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2186 |
| Est. completion date | October 13, 2022 |
| Est. primary completion date | October 13, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Lyon Sud | Pierre Bénite |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Resistance to oncological treatments | 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 | |
| Primary | Presence of biological and tumoral factors related to resistance to oncological treatments | 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 | Presence of clinical factors related to resistance to oncological treatments. | Demographic, pathological, clinical information are recorded electronically on a secured Web application and linked to biospecimens identification. | During the 3-year follow-up | |
| Secondary | Incidence of recurrence and survival | Impact of therapeutics strategies on the incidence of recurrence and survival | at 3 years | |
| Secondary | social characteristics of patients by MOS-SSS test, according to their therapeutic car modalities | 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 | |
| Secondary | quality of life measured by questionnaires (composite measure composed of QLQ-C30, QLQ-CR29 and QLQ-STO22 questionnaires), according to treatment strategies | 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 | |
| Secondary | Intensity of pain perceived by the patient measured by VAS scale | 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 | |
| Secondary | Presence of epidemiological and demographic determinants of delayed access to treatment induction or surgical procedure | Epidemiological and demographic factors will be assessed from the prospective and clinical database. | During the 3-year follow-up | |
| Secondary | Presence of prognostic and predictive biomarkers related to resistance to oncological treatments . | 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 | |
| Secondary | behavioral characteristics of patients by HADS Scale, according to their therapeutic car modalities | 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 |