Clinical trial NCT02866149: Analysis of Circulating Tumor Markers in the Blood (ALCINA)
Official title: Analysis of Circulating Tumor Markers in the Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
circulating tumor biomarkers
circulating tumor DNA
Circulating tumor Cell (CTC)
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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)

Primary outcomes:
measure: Feasibility of the analysis of different blood-borne tumor biomarkers
timeFrame: 18 months
Secondary outcomes:
measure: Correlation with biological and clinical data
timeFrame: 18 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Paris
country: France
facility: Institut Curie (Paris hospital)
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Saint-cloud
country: France
facility: Institut Curie (St Cloud hospital)
Study officials:
affiliation: Institut Curie, Paris (FR)
name: François-Clément BIDARD, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.