Neoplasms

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Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

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Abdominal Neoplasms

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Quality of Life

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Formaldehyde

Only if patient's consent is obtained, biospecimens, including tumor and/or peripheral blood are collected.

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).

Collection of biospecimens and Quality of Life (QoL) assessment

Olivier Glehen, Pr

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.

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

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

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

Demographic, pathological, clinical information are recorded electronically on a secured Web application and linked to biospecimens identification.

Impact of therapeutics strategies on the incidence of recurrence and survival

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).

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.

The patient's perception intensity of pain is measured with a Visual Analogue Scale (VAS).

Epidemiological and demographic factors will be assessed from the prospective and clinical database.

The prognostic and predictive biomarkers related to resistance of oncological treatments will be identified from the biological tumoral and clinical data.

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.

Hospices Civils de Lyon

All patients underwent laparoscopic followed by laparotomic surgical staging.

Non interventional

Olivier GLEHEN, Prof

Peggy JOURDAN-ENFER

The peritoneum is the second most common site of recurrence in patients with colorectal cancer. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the prognosis of these patients and incorporates surgical removal of all visible disease followed by chemical destruction of microscopic disease through chemoperfusion. The most validated predictors of outcome are preoperative tumor burden measured in terms of the peritoneal carcinomatosis index (PCI) and completeness of cytoreduction (CC score). Diagnostic laparoscopy prior to resection is widely used in hepatopancreaticobiliary and colorectal cancer and has been shown to be effective in excluding unnecessary laparotomy associated with higher morbidity.

Study Comparing the Role of the Laparoscopy Surgical Staging in the Peritoneal Carcinomatosis to Laparotomic Approach

To score the Collect detailed detailed Peritoneal Cancer Index (PCI) by laparoscopy following the laparotomy procedure in order to evaluate the accuracy and adequacy of laparoscopic surgical staging comparing to laparotomic approach.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies	NCT02823860	Digestive Perit...	Collection of b...	18 Years -	Hospices Civils de Lyon
Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies	NCT02823860	Digestive Perit...	Collection of b...	18 Years -	Hospices Civils de Lyon
Study Comparing the Role of the Laparoscopy Surgical Staging in the Peritoneal Carcinomatosis to Laparotomic Approach	NCT02829788	Colorectal Peri...	Non interventio...	-	Hospices Civils de Lyon

Spots Global Cancer Trial Database for digestive peritoneal carcinomatosis