Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4

Cancer Clinical Trial

— ALCINA4  

Official title:

Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088395
• Other study ID #: IC 2020-11_ALCINA4
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: June 1, 2031

Study information

• Verified date: May 2024
• Source: Institut Curie
• Contact: Sandra NESPOULOUS
• Phone: 0033147111654
• Email: sandra.nespoulous[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2031
• Est. primary completion date: June 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Blood sample
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 24 months.
• Biopsy
If a specific tumor sample is required, it will be collected only once during the study

Locations

Country	Name	City	State
France	Institut Curie	Paris
France	Institut Curie	Saint-cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of circulating biomarkers in cohort 1	Positivity rate of the detection technique (in %)	Baseline
Primary	Detection rate of circulating biomarkers in cohort 2	Positivity rate of the detection technique (in %)	Baseline
Primary	Detection rate of circulating biomarkers in cohort 2	Positivity rate of the detection technique (in %)	Before treatment
Primary	Detection rate of circulating biomarkers in cohort 2	Positivity rate of the detection technique (in %)	At 3 weeks of treatment
Primary	Detection rate of circulating biomarkers in cohort 2	Positivity rate of the detection technique (in %)	At 9 weeks of treatment
Primary	Detection rate of circulating biomarkers in cohort 2	Positivity rate of the detection technique (in %)	At disease progression
Primary	Detection rate of circulating biomarkers in cohort 1	Positivity rate of the detection technique (in %)	Before surgery
Primary	Detection rate of circulating biomarkers in cohort 1	Positivity rate of the detection technique (in %)	After surgery (from 3 to 5 weeks)
Primary	Detection rate of circulating biomarkers in cohort 1	Positivity rate of the detection technique (in %)	After surgery (from 2 to 3 months)
Primary	Detection rate of circulating biomarkers in cohort 3	Positivity rate of the detection technique (in %)	Baseline
Primary	Detection rate of circulating biomarkers in cohort 3	Positivity rate of the detection technique (in %)	At the end of cycle 1 (each cycle is 21 days)
Primary	Detection rate of circulating biomarkers in cohort 3	Positivity rate of the detection technique (in %)	After surgery (from 2 to 3 months)
Primary	Detection rate of circulating biomarkers in cohort 3	Positivity rate of the detection technique (in %)	At disease progression
Primary	Detection rate of circulating biomarkers in cohort 4	Positivity rate of the detection technique (in %)	At pre-surgery or before starting treatment
Primary	Detection rate of circulating biomarkers in cohort 4	Positivity rate of the detection technique (in %)	At 6 weeks after surgery or after start of treatment