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临床试验/NCT02866149
NCT02866149已完成不适用

Analysis of Circulating Tumor Markers in the Blood

Institut Curie5 个研究点 分布在 1 个国家目标入组 682 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

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

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"

Other

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®"

Other

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"

Experimental

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"

Experimental

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"

Other

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"

Other

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"

Other

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"

Other

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"

Other

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"

Other

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"

Other

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"

Other

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"

Other

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"

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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