Analysis of Circulating Tumor Markers in the Blood (ALCINA) (ALCINA)

Analysis of Circulating Tumor Markers in the Blood

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Biological: Blood sampling; Procedure: Tumor sampling; Other: Stool sampling

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.

• Study Type: Interventional
• Enrollment (Actual): 682
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Centre Georges François Leclerc
  • Montpellier, France, 34298
    • Institut du Cancer de Montpellier
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75005
    • Institut Curie (Paris hospital)
  • Saint-cloud, France, 92210
    • Institut Curie (St Cloud hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: 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	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Experimental: 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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points; Procedure: Tumor sampling; One tumor sampling can be performed, if applicable
Other: 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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points; Procedure: Tumor sampling; One tumor sampling can be performed, if applicable
Other: 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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: 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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: 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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: 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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: Cohort 9 - "NSCLC"; Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points; Procedure: Tumor sampling; One tumor sampling can be performed, if applicable; Other: Stool sampling; Up to 5 blood samplings can be performed at different time points
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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: Cohort 11 - Sarcomas; The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: 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.	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: 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).	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points
Other: 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	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points; Procedure: Tumor sampling; One tumor sampling can be performed, if applicable
Other: 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	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points; Procedure: Tumor sampling; One tumor sampling can be performed, if applicable
Other: 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	Biological: Blood sampling; Up to 5 blood samplings can be performed at different time points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with biological and clinical data	Number of biological analysis results correlated to clinical data. Establishment of a proof of concept	18 months

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Study Director: François-Clément BIDARD, MD PhD, Institut Curie, Paris (FR)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimated): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; circulating tumor DNA; circulating tumor biomarkers; Circulating tumor Cell (CTC)
• Other Study ID Numbers: IC 2015-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP