Analysis of Circulating Tumor Markers in the Blood (ALCINA)
Not Applicable
Completed
- Conditions
- Cancer
- Interventions
- Biological: Blood samplingProcedure: Tumor samplingOther: Stool sampling
- Registration Number
- NCT02866149
- Lead Sponsor
- Institut Curie
- Brief Summary
Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 682
Inclusion Criteria
-
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)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 4 - "CDX PDX" Blood sampling 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. Cohort 4 - "CDX PDX" Tumor sampling 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. Cohort 5 - "Post-TP53" Blood sampling 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. Cohort 7 - "CTC_PD-L1_Breast" Blood sampling Detection of PD-L1 in metastatic breast cancer patients Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator. Cohort 9 - "NSCLC" Blood sampling Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints. Cohort 14 - CNBC Snipe Tumor sampling 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 Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary" Blood sampling Detection of PD-L1 in metastatic lung cancer patients Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator. Cohort 1 - "Anti checkpoint" Blood sampling 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. Cohort 2 - "Oncoscan®" Blood sampling 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 Cohort 9 - "NSCLC" Tumor sampling Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints. Cohort 12 - Faslorad Blood sampling 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. Cohort 14 - CNBC Snipe Blood sampling 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 Cohort 16 - Mum immunothérapie Blood sampling 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 Cohort 3 - "CirCe-PLA" Blood sampling 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. Cohort 3 - "CirCe-PLA" Tumor sampling 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. Cohort 6 - "Palbociclib" Blood sampling 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. Cohort 9 - "NSCLC" Stool sampling Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints. Cohort 11 - Sarcomas Blood sampling The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging. Cohort 13 - MUm Blood sampling 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). Cohort 15 - Breast CLI Blood sampling 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 Cohort 10 - "Palbociclib II" Blood sampling 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. Cohort 15 - Breast CLI Tumor sampling 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
- Primary Outcome Measures
Name Time Method Feasibility of the analysis of different blood-borne tumor biomarkers 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 ".
- Secondary Outcome Measures
Name Time Method Correlation with biological and clinical data 18 months Number of biological analysis results correlated to clinical data. Establishment of a proof of concept
Trial Locations
- Locations (5)
Institut Curie (Paris hospital)
🇫🇷Paris, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Institut du Cancer de Montpellier
🇫🇷Montpellier, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Institut Curie (St Cloud hospital)
🇫🇷Saint-cloud, France