Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample, Biopsy.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 (or more) taken per patient for up to 18, 24 or 36 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.
Interventions
- 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 (or more) taken per patient for up to 18, 24 or 36 months according to the cohorts. - Other Biopsy
If a specific tumor sample is required, it will be collected only once during the study
Primary outcome measures
- Detection rate of circulating biomarkers in cohort 1 [Time frame: Baseline]
- Detection rate of circulating biomarkers in cohort 2 [Time frame: Baseline]
- Detection rate of circulating biomarkers in cohort 2 [Time frame: Before treatment]
- Detection rate of circulating biomarkers in cohort 2 [Time frame: At 3 weeks of treatment]
- Detection rate of circulating biomarkers in cohort 2 [Time frame: At 9 weeks of treatment]
- Detection rate of circulating biomarkers in cohort 2 [Time frame: At disease progression]
- Detection rate of circulating biomarkers in cohort 1 [Time frame: Before surgery]
- Detection rate of circulating biomarkers in cohort 1 [Time frame: After surgery (from 3 to 5 weeks)]
- Detection rate of circulating biomarkers in cohort 1 [Time frame: After surgery (from 2 to 3 months)]
- Detection rate of circulating biomarkers in cohort 3 [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Institut Curie — Paris
- Institut Curie — Saint-Cloud
Identifiers
NCT: NCT05088395 · IC 2020-11