Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT05088395
• Lead Sponsor: Institut Curie

Brief Summary

Multi-cohort exploratory prospective study. Participation in the ALCINA 4 study does not change the standard management of the patient, including the treatments administered. A sampling schedule will be set up for each cohort.

Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples taken per patient for up to 12 or 18 months. If a specific tumor sample is required, it will be collected only once during the study.

Detailed Description

The ALCINA 4 study is a prospective biological cohort study based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy.

Circulating tumour biomarkers in blood have been the subject of much research for several decades, leading to the development in the 1980s of serum protein markers still in use today (CA15.3, ACE, CA125...). In the last decade, research has focused on circulating tumour cells (CTCs), circulating endothelial cells (CECs) and more recently on the detection of circulating tumour DNA (ctDNA) and exosomes (or microvesicles). While ctDNA seems to have a very promising future, other circulating elements such as microRNA are also part of what can/will be studied from a simple blood sample. Broadly speaking, the potential clinical interests of these circulating biomarkers are :

* diagnostic (diagnosis of cancer, or especially diagnosis of genetic mutations present in a known cancer)

* prognostic (to adapt the intensity of treatment to the expected outcome of the patient)

* predictive of the efficacy of targeted therapies (according to the mutational profile of the cancer)

* to study mechanisms of resistance during treatment . The multiplicity of these potential blood biomarkers is matched by a large number of detection techniques, for example for CTCs or ctDNA.

The major new challenge in research on circulating biomarkers is to replace molecular analyses on tumour tissue obtained by biopsy (e.g. the search for somatic cancer mutations) by a simple blood sample ("liquid biopsy"). This objective, which is technologically possible in the very short term and particularly interesting - both medically (for patients) and economically - requires the comparison of data from blood markers with those from tumour tissue samples. Furthermore, there is an important trend to combine several levels of analysis together (e.g. ctDNA and serum protein markers) to refine the performance of blood tests.

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-21
• Study Start: 2022-05-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Primary Completion: 2031-06-01
• Study Completion: 2031-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2050

Inclusion Criteria

• Patient treated for cancer at one of the participating center
• 18 years old or higher
• Signed informed consent form
• Patient not deprived of their liberty or under guardianship (including temporary guardianship)
• Patient covered by social security scheme
• Patient with no compliance issue (related to geographical, social or psychological reasons) for study follow up
• Other additional criteria will be defined (defining tumor type and clinical setting), by cohort

If a biopsy tumor sample is to be taken:

• Tumor considered as accessible by biopsy (at the investigator's discretion).
• Normal blood coagulation tests (if applicable, and in case of a non-superficial tumor lesion).
• No anticoagulant or antiaggregant treatment for the biopsy.

Exclusion Criteria :

Pregnant and/or breast-feeding women depending on cohort.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Detection rate of circulating biomarkers in cohort 3	At disease progression	Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 1	After surgery (from 2 to 3 months)	Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 2	At disease progression	Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 4	At 6 weeks after surgery or after start of treatment	Positivity rate of the detection technique (in %)

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Saint-cloud, France