Analysis of Circulating Tumor Markers in the Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 682
- 试验地点
- 5
- 主要终点
- Feasibility of the analysis of different blood-borne tumor biomarkers
研究概览
简要总结
Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.
详细描述
Exploratory multi-cohort study including different types of cancer (different organs and/or different histological types).
Each kind of blood-borne biological markers analyses corresponds to a cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Patient with any tumoral disease (proven or suspected), of any type and stage
- •More than18 years old
- •Signed informed consent form
- •Additional inclusion criteria if a tumor sample is needed:
- •Tumor considered as accessible by biopsy
- •Normal blood coagulation tests on the last blood analysis
- •Non-inclusion Criteria:
- •Patient in detention or protected by the law
- •Patient who cannot comply with the study follow up for geographical, social or psychological reasons
- •Additional non-inclusion criteria if a tumor sample is needed:
- •Anticoagulant or antiaggregant that cannot be interrupted for the biopsy
- •central-nervous system metastases only (unless a diagnostic or curative surgery is planned before the inclusion in the study)
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 - "Anti checkpoint"
Monitoring of patients with tumours treated by immune therapy.
Timing of blood sampling:
- inclusion
- after #8 weeks on therapy
- at progression or 6 months from inclusion for patient without progressive disease
- if toxicity grade 3 or 4, or grade 2 until 1 month.
干预措施: Blood sampling (Biological)
Cohort 2 - "Oncoscan®"
Monitoring of patients with HER 2+/- breast cancer and correlation with genome-wide copy number, loss of heterozygosity detection, as well as identification of frequently tested somatic mutations (Oncoscan® assays).
Timing of blood sampling:
- inclusion
- after 1 cycle of therapy (weeks 3-4)
- up to 2 other samples, timepoints decided by the investigator
干预措施: Blood sampling (Biological)
Cohort 3 - "CirCe-PLA"
Feasibility of Proximity-Ligation Assay (PLA) to study membrane proteins dimerisation by on isolated tumour cells in patients with HER2+/- breast cancer (HER 2+/-).
One tumor sampling.
Timing of blood sampling:
- Inclusion
- up to 3 other samples, timepoints decided by the investigator.
干预措施: Blood sampling (Biological)
Cohort 3 - "CirCe-PLA"
Feasibility of Proximity-Ligation Assay (PLA) to study membrane proteins dimerisation by on isolated tumour cells in patients with HER2+/- breast cancer (HER 2+/-).
One tumor sampling.
Timing of blood sampling:
- Inclusion
- up to 3 other samples, timepoints decided by the investigator.
干预措施: Tumor sampling (Procedure)
Cohort 4 - "CDX PDX"
Establishment of xenografts from tumor (PDX) and from Circulating Tumour Cell (CDX) by tumour and blood sampling.
One tumor sampling.
Timing of blood sampling:
- Inclusion
- up to 3 other samples, timepoints decided by the investigator.
干预措施: Blood sampling (Biological)
Cohort 4 - "CDX PDX"
Establishment of xenografts from tumor (PDX) and from Circulating Tumour Cell (CDX) by tumour and blood sampling.
One tumor sampling.
Timing of blood sampling:
- Inclusion
- up to 3 other samples, timepoints decided by the investigator.
干预措施: Tumor sampling (Procedure)
Cohort 5 - "Post-TP53"
Follow-up of patients previously treated by neoadjuvant chemotherapy for triple negative breast cancer.
Timing of blood sampling:
- Inclusion
- up to 3 other samples, timepoints decided by the investigator.
干预措施: Blood sampling (Biological)
Cohort 6 - "Palbociclib"
Monitoring of patients treated with palbociclib
Timing of blood sampling:
- Inclusion day (2 samples)
- after #2 weeks of therapy
- after #4 weeks of therapy
- at progression.
干预措施: Blood sampling (Biological)
Cohort 7 - "CTC_PD-L1_Breast"
Detection of PD-L1 in metastatic breast cancer patients
Timing of blood sampling:
- Inclusion
- up to 3 other samples, timepoints decided by the investigator.
干预措施: Blood sampling (Biological)
Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary"
Detection of PD-L1 in metastatic lung cancer patients
Timing of blood sampling:
- Inclusion
- up to 3 other samples, timepoints decided by the investigator.
干预措施: Blood sampling (Biological)
Cohort 9 - "NSCLC"
Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy.
Blood sampling at 4 timepoints.
干预措施: Blood sampling (Biological)
Cohort 9 - "NSCLC"
Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy.
Blood sampling at 4 timepoints.
干预措施: Tumor sampling (Procedure)
Cohort 9 - "NSCLC"
Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy.
Blood sampling at 4 timepoints.
干预措施: Stool sampling (Other)
Cohort 10 - "Palbociclib II"
Monitoring of patient with a metastatic breast cancer treated by palbociclib.
Timing of blood sampling:
- Inclusion
- after #4 weeks of therapy
- at the first tumoral evaluation (month 3 or 4)
- at progression.
干预措施: Blood sampling (Biological)
Cohort 11 - Sarcomas
The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging.
干预措施: Blood sampling (Biological)
Cohort 12 - Faslorad
Monitoring of patient with a metastatic breast cancer initiating a treatment by Faslodex-Afinitor.
Timing of blood sampling:
- Inclusion
- after #3-5 weeks of therapy
- at the first tumoral evaluation (month 2 or 3)
- at progression.
干预措施: Blood sampling (Biological)
Cohort 13 - MUm
The cohort concerns patients with uveal melanoma in the 1st systemic line at the metastatic stage (may have had prior adjuvant therapy or surgery/radiofrequency).
Timing of blood sampling:
- J1C1
- J2C1
- J1C2
- J1C5 (first tumoral evaluation).
干预措施: Blood sampling (Biological)
Cohort 14 - CNBC Snipe
This cohort concerns patients with metastatic Non-Small Cell lung Cancer receiving anti-PD-1/PD-L1.
One tumour sampling.
Timing of blood sampling:
- before treatment
- at W8 of treatment (after radiological examination)
- at W12 of treatment
- at progression or 18 months after the beginning of treatment
干预措施: Blood sampling (Biological)
Cohort 14 - CNBC Snipe
This cohort concerns patients with metastatic Non-Small Cell lung Cancer receiving anti-PD-1/PD-L1.
One tumour sampling.
Timing of blood sampling:
- before treatment
- at W8 of treatment (after radiological examination)
- at W12 of treatment
- at progression or 18 months after the beginning of treatment
干预措施: Tumor sampling (Procedure)
Cohort 15 - Breast CLI
This cohort concerns patients with metastatic lobular breast cancer One tumour sampling.
Timing of blood sampling:
- At inclusion
- After biopsy post inclusion (or in 15 days after)
- after 1 or 2 months of treatment
- at progression or 18 months after inclusion
干预措施: Blood sampling (Biological)
Cohort 15 - Breast CLI
This cohort concerns patients with metastatic lobular breast cancer One tumour sampling.
Timing of blood sampling:
- At inclusion
- After biopsy post inclusion (or in 15 days after)
- after 1 or 2 months of treatment
- at progression or 18 months after inclusion
干预措施: Tumor sampling (Procedure)
Cohort 16 - Mum immunothérapie
This cohort concerns patients with metastatic uveal melanoma before immunotherapy treatment.
Timing of blood sampling :
- at inclusion
- at cycle 2 or 3 of treatment
- at the first tumoral evaluation (C5D1)
- at progression
干预措施: Blood sampling (Biological)
结局指标
主要结局
Feasibility of the analysis of different blood-borne tumor biomarkers
时间窗: 18 months
Success rate of the tested detection techniques. The success rate of a given detection technique is calculated by the ratio " detection success " / " number of screened patients ".
次要结局
- Correlation with biological and clinical data(18 months)
