Analysis of Circulating Tumor Markers in the Blood (ALCINA)

Institut Curie

Status: Completed

Conditions: Cancer

Treatments: Procedure: Tumor sampling; Biological: Blood sampling; Other: Stool sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02866149

IC 2015-02

Details and patient eligibility

About

Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.

Full 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.

Enrollment: 682 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patient with any tumoral disease (proven or suspected), of any type and stage

2. More than18 years old

3. Signed informed consent form

   Additional inclusion criteria if a tumor sample is needed:

4. Tumor considered as accessible by biopsy

5. Normal blood coagulation tests on the last blood analysis

Non-inclusion Criteria:

1. Patient in detention or protected by the law

2. 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:

3. Anticoagulant or antiaggregant that cannot be interrupted for the biopsy

4. central-nervous system metastases only (unless a diagnostic or curative surgery is planned before the inclusion in the study)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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682 participants in 16 patient groups

Cohort 1 - "Anti checkpoint"

Other group

Description:

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.

Treatment:

Biological: Blood sampling

Cohort 2 - "Oncoscan®"

Other group

Description:

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

Treatment:

Biological: Blood sampling

Cohort 3 - "CirCe-PLA"

Experimental group

Description:

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.

Treatment:

Biological: Blood sampling

Procedure: Tumor sampling

Cohort 4 - "CDX PDX"

Other group

Description:

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.

Treatment:

Biological: Blood sampling

Procedure: Tumor sampling

Cohort 5 - "Post-TP53"

Other group

Description:

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.

Treatment:

Biological: Blood sampling

Cohort 6 - "Palbociclib"

Other group

Description:

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.

Treatment:

Biological: Blood sampling

Cohort 7 - "CTC_PD-L1_Breast"

Other group

Description:

Detection of PD-L1 in metastatic breast cancer patients Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator.

Treatment:

Biological: Blood sampling

Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary"

Other group

Description:

Detection of PD-L1 in metastatic lung cancer patients Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator.

Treatment:

Biological: Blood sampling

Cohort 9 - "NSCLC"

Other group

Description:

Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints.

Treatment:

Other: Stool sampling

Biological: Blood sampling

Procedure: Tumor sampling

Cohort 10 - "Palbociclib II"

Other group

Description:

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.

Treatment:

Biological: Blood sampling

Cohort 11 - Sarcomas

Other group

Description:

The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging.

Treatment:

Biological: Blood sampling

Cohort 12 - Faslorad

Other group

Description:

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.

Treatment:

Biological: Blood sampling

Cohort 13 - MUm

Other group

Description:

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).

Treatment:

Biological: Blood sampling

Cohort 14 - CNBC Snipe

Other group

Description:

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

Treatment:

Biological: Blood sampling

Procedure: Tumor sampling

Cohort 15 - Breast CLI

Other group

Description:

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

Treatment:

Biological: Blood sampling

Procedure: Tumor sampling

Cohort 16 - Mum immunothérapie

Other group

Description:

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

Treatment:

Biological: Blood sampling