Analysis of Circulating Tumor Markers in the Blood (ALCINA)

NCT02866149 | Completed

• 1 other identifier: IC 2015-02
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Cancer

Keywords

Cancer; circulating tumor biomarkers; circulating tumor DNA; Circulating tumor Cell (CTC)

Outcome Measures

Primary Outcomes (1)

• Feasibility of the analysis of different blood-borne tumor biomarkers

  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 ".

  18 months

Secondary Outcomes (1)

• Correlation with biological and clinical data

  18 months

Study Arms (16)

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.

Biological: Blood sampling

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

Biological: Blood sampling

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.

Biological: Blood sampling; Procedure: Tumor sampling

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.

Biological: Blood sampling; Procedure: Tumor sampling

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.

Biological: Blood sampling

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.

Biological: Blood sampling

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.

Biological: Blood sampling

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.

Biological: Blood sampling

Cohort 9 - "NSCLC"

OTHER

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

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

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.

Biological: Blood sampling

Cohort 11 - Sarcomas

OTHER

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

Biological: Blood sampling

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.

Biological: Blood sampling

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).

Biological: Blood sampling

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

Biological: Blood sampling; Procedure: Tumor sampling

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

Biological: Blood sampling; Procedure: Tumor sampling

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

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

Up to 5 blood samplings can be performed at different time points

Cohort 1 - "Anti checkpoint"; Cohort 10 - "Palbociclib II"; Cohort 11 - Sarcomas; Cohort 12 - Faslorad; Cohort 13 - MUm; Cohort 14 - CNBC Snipe; Cohort 15 - Breast CLI; Cohort 16 - Mum immunothérapie; Cohort 2 - "Oncoscan®"; Cohort 3 - "CirCe-PLA"; Cohort 4 - "CDX PDX"; Cohort 5 - "Post-TP53"; Cohort 6 - "Palbociclib"; Cohort 7 - "CTC_PD-L1_Breast"; Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary"; Cohort 9 - "NSCLC"

Tumor sampling PROCEDURE

One tumor sampling can be performed, if applicable

Cohort 14 - CNBC Snipe; Cohort 15 - Breast CLI; Cohort 3 - "CirCe-PLA"; Cohort 4 - "CDX PDX"; Cohort 9 - "NSCLC"

Stool sampling OTHER

Up to 5 blood samplings can be performed at different time points

Cohort 9 - "NSCLC"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with any tumoral disease (proven or suspected), of any type and stage
• More than18 years old
• Signed informed consent form
• Tumor considered as accessible by biopsy
• Normal blood coagulation tests on the last blood analysis
• Patient in detention or protected by the law
• Patient who cannot comply with the study follow up for geographical, social or psychological reasons
• Anticoagulant or antiaggregant that cannot be interrupted for the biopsy

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (5)

Centre Georges François Leclerc

Dijon, 21079, France

Location

Institut du Cancer de Montpellier

Montpellier, 34298, France

Location

Institut Curie (Paris hospital)

Paris, 75005, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Institut Curie (St Cloud hospital)

Saint-Cloud, 92210, France

Location

Related Publications (6)

• Rodrigues M, Ramtohul T, Rampanou A, Sandoval JL, Houy A, Servois V, Mailly-Giacchetti L, Pierron G, Vincent-Salomon A, Cassoux N, Mariani P, Dutriaux C, Pracht M, Ryckewaert T, Kurtz JE, Roman-Roman S, Piperno-Neumann S, Bidard FC, Stern MH, Renault S. Prospective assessment of circulating tumor DNA in patients with metastatic uveal melanoma treated with tebentafusp. Nat Commun. 2024 Oct 14;15(1):8851. doi: 10.1038/s41467-024-53145-0.

  PMID: 39402032 DERIVED

• Eslami-S Z, Cortes-Hernandez LE, Sinoquet L, Gauthier L, Vautrot V, Cayrefourcq L, Avoscan L, Jacot W, Pouderoux S, Viala M, Thomas QD, Lamy PJ, Quantin X, Gobbo J, Alix-Panabieres C. Circulating tumour cells and PD-L1-positive small extracellular vesicles: the liquid biopsy combination for prognostic information in patients with metastatic non-small cell lung cancer. Br J Cancer. 2024 Jan;130(1):63-72. doi: 10.1038/s41416-023-02491-9. Epub 2023 Nov 16.

  PMID: 37973956 DERIVED

• Sinoquet L, Jacot W, Gauthier L, Pouderoux S, Viala M, Cayrefourcq L, Quantin X, Alix-Panabieres C. Programmed Cell Death Ligand 1-Expressing Circulating Tumor Cells: A New Prognostic Biomarker in Non-Small Cell Lung Cancer. Clin Chem. 2021 Nov 1;67(11):1503-1512. doi: 10.1093/clinchem/hvab131.

  PMID: 34355741 DERIVED

• Darrigues L, Pierga JY, Bernard-Tessier A, Bieche I, Silveira AB, Michel M, Loirat D, Cottu P, Cabel L, Dubot C, Geiss R, Ricci F, Vincent-Salomon A, Proudhon C, Bidard FC. Circulating tumor DNA as a dynamic biomarker of response to palbociclib and fulvestrant in metastatic breast cancer patients. Breast Cancer Res. 2021 Mar 6;23(1):31. doi: 10.1186/s13058-021-01411-0.

  PMID: 33676547 DERIVED

• Cabel L, Rosenblum D, Lerebours F, Brain E, Loirat D, Bergqvist M, Cottu P, Donnadieu A, Bethune A, Kiavue N, Rodrigues M, Pierga JY, Tanguy ML, Bidard FC. Plasma thymidine kinase 1 activity and outcome of ER+ HER2- metastatic breast cancer patients treated with palbociclib and endocrine therapy. Breast Cancer Res. 2020 Sep 14;22(1):98. doi: 10.1186/s13058-020-01334-2.

  PMID: 32928264 DERIVED

• Jacot W, Mazel M, Mollevi C, Pouderoux S, D'Hondt V, Cayrefourcq L, Bourgier C, Boissiere-Michot F, Berrabah F, Lopez-Crapez E, Bidard FC, Viala M, Maudelonde T, Guiu S, Alix-Panabieres C. Clinical Correlations of Programmed Cell Death Ligand 1 Status in Liquid and Standard Biopsies in Breast Cancer. Clin Chem. 2020 Aug 1;66(8):1093-1101. doi: 10.1093/clinchem/hvaa121.

  PMID: 32712650 DERIVED

MeSH Terms

Conditions

Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François-Clément BIDARD, MD PhD

  Institut Curie, Paris (FR)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 15, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (5)