Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,186
- 试验地点
- 2
- 主要终点
- Resistance to oncological treatments
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Minor patient
- •Adult unable to consent
- •Patient refusal to participate in the study
结局指标
主要结局
Resistance to oncological treatments
时间窗: 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
Presence of biological and tumoral factors related to resistance to oncological treatments
时间窗: 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
次要结局
- Incidence of recurrence and survival(at 3 years)
- social characteristics of patients by MOS-SSS test, according to their therapeutic car modalities(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 clinical factors related to resistance to oncological treatments.(During the 3-year follow-up)
- Intensity of pain perceived by the patient measured by VAS scale(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 prognostic and predictive biomarkers related to resistance to oncological treatments .(During the 3-year follow-up)
- quality of life measured by questionnaires (composite measure composed of QLQ-C30, QLQ-CR29 and QLQ-STO22 questionnaires), according to treatment strategies(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(During the 3-year follow-up)
- behavioral characteristics of patients by HADS Scale, according to their therapeutic car modalities(at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months)