NCT04025541: ALCINA2

Analysis of Circulating Tumor Markers in Blood

Recruiting now NA Last updated 2 April 2025

What this trial tests

NA trial testing Blood sampling in Cancer in 992 participants. Currently enrolling.

Timeline

29 May 2018

Primary endpoint
29 May 2026

29 May 2029

Quick facts

Lead sponsor	Institut du Cancer de Montpellier - Val d'Aurelle
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	992
Start date	29 May 2018
Primary completion	29 May 2026
Estimated completion	29 May 2029
Sites	2 locations across France

Drugs / interventions tested

• Blood sampling
• Blood sampling C3 — full drug profile →
• Blood sampling C4/7/10/13
• Blood sampling C5
• Blood sampling C6 — full drug profile →
• Blood sampling C8 — full drug profile →
• Blood sampling C9 — full drug profile →
• Blood sampling C11 + FFPE
• Blood sampling C12 — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →
• Breast Cancer — all drugs for Breast Cancer →
• Sarcoma — all drugs for Sarcoma →
• Lung Cancers — all drugs for Lung Cancers →

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle — full company profile →

Who can join

18 and older, any sex, with Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Eslami-S Z, Cortés-Hernández LE, Sinoquet L, Gauthier L, et al · · 2024 · cited 30× · PMID 37973956 · DOI 10.1038/s41416-023-02491-9
2. Pharmacokinetic Variability Drives Palbociclib-Induced Neutropenia in Metastatic Breast Cancer Patients: Drug-Drug Interactions Are the Usual Suspects.
   Leenhardt F, Fiteni F, Gauthier L, Alexandre M, et al · · 2022 · cited 9× · PMID 35456675 · DOI 10.3390/pharmaceutics14040841
3. Liquid chromatography-tandem mass spectrometric assay for the quantification of CDK4/6 inhibitors in human plasma in a clinical context of drug-drug interaction.
   Leenhardt F, Gracia M, Perrin C, Muracciole-Bich C, et al · · 2020 · cited 8× · PMID 32623316 · DOI 10.1016/j.jpba.2020.113438
4. Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug-drug interactions with oral targeted therapy.
   Leenhardt F, Alexandre M, Guiu S, Pouderoux S, et al · · 2021 · cited 7× · PMID 34286354 · DOI 10.1007/s00280-021-04331-0
5. First evidence of AXL expression on circulating tumor cells in metastatic breast cancer patients: A proof-of-concept study.
   Bardol T, Eslami-S Z, Masmoudi D, Alexandre M, et al · · 2024 · cited 5× · PMID 38132919 · DOI 10.1002/cam4.6843
6. Liquid biopsy reveals the immune status and protein profiles linked to CTC burden and clinical outcomes in metastatic breast cancer.
   Kurma K, Bardol T, Mollevi C, Eslami-S Z, et al · · 2026 · PMID 42001180 · DOI 10.1186/s13046-026-03709-3
7. NOTCH1 intracellular domain stabilization by MDM2 plays a major role in NSCLC response to platinum.
   Bernardo S, Brunet L, Thomas QD, Bracquemond D, et al · · 2026 · PMID 41545766 · DOI 10.1038/s44321-025-00354-9