Analysis of Circulating Tumor Markers in Blood

Cancer Clinical Trial

— ALCINA 2  

Official title:

Analysis of Circulating Tumor Markers in Blood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025541
• Other study ID #: PROICM 2017-05 BAL
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: May 29, 2023

Study information

• Verified date: November 2021
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: texier emmannuelle
• Phone: 0467613102
• Email: emmanuelle.texier[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The new major challenge in the research concerns the circulating biomarkers, which aim at replacing the molecular analyses on tumour tissue obtained by biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.

The study ALCINA 2 rests exactly on the principle of small cohorts, which correspond each to a clinical situation and/or a technique of different implemented detection, so as to generate data of feasibility and proof of concept. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: May 29, 2023
• Est. primary completion date: May 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,

2. Man or woman = 18 years,

3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.

Exclusion Criteria:

1. Private persons of freedom or under guardianship,

2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,

3. Pregnant woman and/or breast-feeding,

4. Unaffiliated patient to Social Protection System,

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• Blood sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	ICM	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of the feasibility of the various blood tumoral biomarkers analysis	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"	4 YEARS
Secondary	COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related	Number of participants with treatment-related neutropenia as assessed by CTCAE v4.03	4 YEARS
Secondary	COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related	Number of participants with treatment-related hepatic toxicity as assessed by CTCAE v4.03	4 YEARS