- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04025541
Analysis of Circulating Tumor Markers in Blood (ALCINA 2)
Study Overview
Detailed 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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: texier emmannuelle
- Phone Number: 0467613102
- Email: emmanuelle.texier@icm.unicancer.fr
Study Locations
-
-
-
Montpellier, France, 34298
- Recruiting
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
-
Contact:
- Marc Ychou, MD, PhD
- Phone Number: 33-4-6761-3066
- Email: mychou@valdorel.fnclcc.fr
-
Contact:
- Jean-Pierre BLEUSE
- Phone Number: 0467613102
- Email: jean-pierre.bleuse@icm.unicancer.fr
-
Montpellier, France, 34298
- Recruiting
- ICM
-
Contact:
- William JACOT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
- Man or woman ≥ 18 years,
- Obtaining of the informed consent signed before any procedure of specific preselection on approval.
Exclusion Criteria:
- Private persons of freedom or under guardianship,
- Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
- Pregnant woman and/or breast-feeding,
- Unaffiliated patient to Social Protection System,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: COHORT 1 BREAST TUMOR/PALBOCICLIB
Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib BLOOD SAMPLING |
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Other Names:
|
Other: COHORT 2 BREAST TUMOR / RIBOCICLIB
Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib BLOOD SAMPLING |
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimation of the feasibility of the various blood tumoral biomarkers analysis
Time Frame: 4 YEARS
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
Time Frame: 4 YEARS
|
Number of participants with treatment-related neutropenia as assessed by CTCAE v4.03
|
4 YEARS
|
COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related
Time Frame: 4 YEARS
|
Number of participants with treatment-related hepatic toxicity as assessed by CTCAE v4.03
|
4 YEARS
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Leenhardt F, Alexandre M, Guiu S, Pouderoux S, Beaujouin M, Lossaint G, Philibert L, Evrard A, Jacot W. Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug-drug interactions with oral targeted therapy. Cancer Chemother Pharmacol. 2021 Oct;88(4):723-729. doi: 10.1007/s00280-021-04331-0. Epub 2021 Jul 20.
- Leenhardt F, Gracia M, Perrin C, Muracciole-Bich C, Marion B, Roques C, Alexandre M, Firmin N, Pouderoux S, Mbatchi L, Gongora C, Jacot W, Evrard A. Liquid chromatography-tandem mass spectrometric assay for the quantification of CDK4/6 inhibitors in human plasma in a clinical context of drug-drug interaction. J Pharm Biomed Anal. 2020 Sep 5;188:113438. doi: 10.1016/j.jpba.2020.113438. Epub 2020 Jun 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PROICM 2017-05 BAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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