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Analysis of Circulating Tumor Markers in the Blood (ALCINA) (ALCINA)

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ClinicalTrials.gov Identifier: NCT02866149
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE July 2015
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
Feasibility of the analysis of different blood-borne tumor biomarkers [ Time Frame: 3 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: August 9, 2016)
Correlation with biological and clinical data [ Time Frame: 3 years ]
Number of biological analysis results correlated to clinical data. Establishment of a proof of concept
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 the Blood (ALCINA)
Official Title  ICMJE Analysis of Circulating Tumor Markers in the Blood
Brief Summary Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.
Detailed Description

Exploratory multi-cohort study including different types of cancer (different organs and/or different histological types).

Each kind of blood-borne biological markers analyses corresponds to a cohort.

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
    Up to 5 blood samplings can be performed at different time points
  • Procedure: Tumor sampling
    One tumor sampling can be performed, if applicable
  • Other: Stool sampling
    Up to 5 blood samplings can be performed at different time points
Study Arms  ICMJE
  • Cohort 1 - "Anti checkpoint"

    Monitoring of patients with tumours treated by immune therapy.

    Timing of blood sampling:

    • inclusion
    • after #8 weeks on therapy
    • at progression or 6 months from inclusion for patient without progressive disease
    • if toxicity grade 3 or 4, or grade 2 until 1 month.
    Intervention: Biological: Blood sampling
  • Cohort 2 - "Oncoscan®"

    Monitoring of patients with HER 2+/- breast cancer and correlation with genome-wide copy number, loss of heterozygosity detection, as well as identification of frequently tested somatic mutations (Oncoscan® assays).

    Timing of blood sampling:

    • inclusion
    • after 1 cycle of therapy (weeks 3-4)
    • up to 2 other samples, timepoints decided by the investigator
    Intervention: Biological: Blood sampling
  • Experimental: Cohort 3 - "CirCe-PLA"

    Feasibility of Proximity-Ligation Assay (PLA) to study membrane proteins dimerisation by on isolated tumour cells in patients with HER2+/- breast cancer (HER 2+/-).

    One tumor sampling.

    Timing of blood sampling:

    • Inclusion
    • up to 3 other samples, timepoints decided by the investigator.
    Interventions:
    • Biological: Blood sampling
    • Procedure: Tumor sampling
  • Cohort 4 - "CDX PDX"

    Establishment of xenografts from tumor (PDX) and from Circulating Tumour Cell (CDX) by tumour and blood sampling.

    One tumor sampling.

    Timing of blood sampling:

    • Inclusion
    • up to 3 other samples, timepoints decided by the investigator.
    Interventions:
    • Biological: Blood sampling
    • Procedure: Tumor sampling
  • Cohort 5 - "Post-TP53"

    Follow-up of patients previously treated by neoadjuvant chemotherapy for triple negative breast cancer.

    Timing of blood sampling:

    • Inclusion
    • up to 3 other samples, timepoints decided by the investigator.
    Intervention: Biological: Blood sampling
  • Cohort 6 - "Palbociclib"

    Monitoring of patients treated with palbociclib

    Timing of blood sampling:

    • Inclusion day (2 samples)
    • after #2 weeks of therapy
    • after #4 weeks of therapy
    • at progression.
    Intervention: Biological: Blood sampling
  • Cohort 7 - "CTC_PD-L1_Breast"

    Detection of PD-L1 in metastatic breast cancer patients

    Timing of blood sampling:

    • Inclusion
    • up to 3 other samples, timepoints decided by the investigator.
    Intervention: Biological: Blood sampling
  • Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary"

    Detection of PD-L1 in metastatic lung cancer patients

    Timing of blood sampling:

    • Inclusion
    • up to 3 other samples, timepoints decided by the investigator.
    Intervention: Biological: Blood sampling
  • Cohort 9 - "NSCLC"

    Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy.

    Blood sampling at 4 timepoints.

    Interventions:
    • Biological: Blood sampling
    • Procedure: Tumor sampling
    • Other: Stool sampling
  • Cohort 10 - "Palbociclib II"

    Monitoring of patient with a metastatic breast cancer treated by palbociclib.

    Timing of blood sampling:

    • Inclusion
    • after #4 weeks of therapy
    • at the first tumoral evaluation (month 3 or 4)
    • at progression.
    Intervention: Biological: Blood sampling
  • Cohort 11 - Sarcomas
    The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging.
    Intervention: Biological: Blood sampling
  • Cohort 12 - Faslorad

    Monitoring of patient with a metastatic breast cancer initiating a treatment by Faslodex-Afinitor.

    Timing of blood sampling:

    • Inclusion
    • after #3-5 weeks of therapy
    • at the first tumoral evaluation (month 2 or 3)
    • at progression.
    Intervention: Biological: Blood sampling
  • Cohort 13 - MUm

    The cohort concerns patients with uveal melanoma in the 1st systemic line at the metastatic stage (may have had prior adjuvant therapy or surgery/radiofrequency).

    Timing of blood sampling:

    • J1C1
    • J2C1
    • J1C2
    • J1C5 (first tumoral evaluation).
    Intervention: Biological: Blood sampling
  • Cohort 14 - CNBC Snipe

    This cohort concerns patients with metastatic Non-Small Cell lung Cancer receiving anti-PD-1/PD-L1.

    One tumour sampling.

    Timing of blood sampling:

    • before treatment
    • at W8 of treatment (after radiological examination)
    • at W12 of treatment
    • at progression or 18 months after the beginning of treatment
    Interventions:
    • Biological: Blood sampling
    • Procedure: Tumor sampling
  • Cohort 15 - Breast CLI

    This cohort concerns patients with metastatic lobular breast cancer One tumour sampling.

    Timing of blood sampling:

    • At inclusion
    • After biopsy post inclusion (or in 15 days after)
    • after 1 or 2 months of treatment
    • at progression or 18 months after inclusion
    Interventions:
    • Biological: Blood sampling
    • Procedure: Tumor sampling
Publications * Not Provided

*   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: November 22, 2019)
760
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2016)
620
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient with any tumoral disease (proven or suspected), of any type and stage
  2. More than18 years old
  3. Signed informed consent form

    Additional inclusion criteria if a tumor sample is needed:

  4. Tumor considered as accessible by biopsy
  5. Normal blood coagulation tests on the last blood analysis

Non-inclusion Criteria:

  1. Patient in detention or protected by the law
  2. Patient who cannot comply with the study follow up for geographical, social or psychological reasons

    Additional non-inclusion criteria if a tumor sample is needed:

  3. Anticoagulant or antiaggregant that cannot be interrupted for the biopsy
  4. central-nervous system metastases only (unless a diagnostic or curative surgery is planned before the inclusion in the study)
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: Anne-Sophie PLISSONNIER anne-sophie.plissonnier@curie.fr
Contact: François-Clément BIDARD, MD PhD +33 144 324 682 francois-clement.bidard@curie.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866149
Other Study ID Numbers  ICMJE IC 2015-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Curie
Study Sponsor  ICMJE Institut Curie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: François-Clément BIDARD, MD PhD Institut Curie, Paris (FR)
PRS Account Institut Curie
Verification Date November 2019

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