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出境医 / 临床实验 / Analysis of Circulating Tumor Markers in Blood (ALCINA 2)

Analysis of Circulating Tumor Markers in Blood (ALCINA 2)

Study Description
Brief Summary:
The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

Condition or disease Intervention/treatment Phase
Cancer Biological: Blood sampling Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Analysis of Circulating Tumor Markers in Blood
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : May 29, 2021
Estimated Study Completion Date : May 29, 2022
Arms and Interventions
Arm Intervention/treatment
COHORT 1 BREAST TUMOR/PALBOCICLIB

Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib

BLOOD SAMPLING

 Biological: Blood sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Other Name: Tumor sampling
COHORT 2 BREAST TUMOR / RIBOCICLIB

Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib

BLOOD SAMPLING

 Biological: Blood sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Other Name: Tumor sampling
Outcome Measures
Primary Outcome Measures :
  1. 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"


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
  2. Man or woman ≥ 18 years,
  3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.

Exclusion Criteria:

  1. Private persons of freedom or under guardianship,
  2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
  3. Pregnant woman and/or breast-feeding,
  4. Unaffiliated patient to Social Protection System,
Contacts and Locations

Contacts
Layout table for location contacts
Contact: texier emmannuelle 0467613102 emmanuelle.texier@icm.unicancer.fr

Locations
Layout table for location information
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD    33-4-6761-3066    mychou@valdorel.fnclcc.fr   
Contact: Jean-Pierre BLEUSE    0467613102    jean-pierre.bleuse@icm.unicancer.fr   
ICM Recruiting
Montpellier, France, 34298
Contact: WILLIAM JACOT         
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE May 29, 2018
Estimated Primary Completion Date May 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019) 		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"
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analysis of Circulating Tumor Markers in Blood
Official Title  ICMJE Analysis of Circulating Tumor Markers in Blood
Brief Summary The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cancer
Intervention  ICMJE Biological: Blood sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Other Name: Tumor sampling
Study Arms  ICMJE
  • COHORT 1 BREAST TUMOR/PALBOCICLIB

    Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib

    BLOOD SAMPLING

    Intervention: Biological: Blood sampling
  • COHORT 2 BREAST TUMOR / RIBOCICLIB

    Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib

    BLOOD SAMPLING

    Intervention: Biological: Blood sampling
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019) 		620
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 29, 2022
Estimated Primary Completion Date May 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
  2. Man or woman ≥ 18 years,
  3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.

Exclusion Criteria:

  1. Private persons of freedom or under guardianship,
  2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
  3. Pregnant woman and/or breast-feeding,
  4. Unaffiliated patient to Social Protection System,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: texier emmannuelle 0467613102 emmanuelle.texier@icm.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025541
Other Study ID Numbers  ICMJE PROICM 2017-05 BAL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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