Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-28 @ 4:23 PM
Study NCT ID:
NCT05088395
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4
Sponsor:
Institut Curie
Organization:
Study Overview
Official Title:
Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALCINA4
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: