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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 : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief Summary:
Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.

Condition or disease Intervention/treatment Phase
Cancer Biological: Blood sampling Procedure: Tumor sampling Other: Stool sampling Not Applicable

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.


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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 the Blood
Actual Study Start Date : July 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
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.
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

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
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

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.
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

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.
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

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.
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

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.
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

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.
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

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.
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

Cohort 9 - "NSCLC"

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

Blood sampling at 4 timepoints.

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

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.
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

Cohort 11 - Sarcomas
The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging.
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

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.
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points

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).
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points




Primary Outcome Measures :
  1. 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 ".


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866149


Contacts
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Contact: Patricia TRESCA, MD patricia.tresca@curie.fr
Contact: François-Clément BIDARD, MD PhD +33 144 324 682 francois-clement.bidard@curie.fr

Locations
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France
Centre Georges François Leclerc Not yet recruiting
Dijon, France, 21079
Principal Investigator: François GHIRINGHELLI, MD         
Institut du Cancer de Montpellier Recruiting
Montpellier, France, 34298
Contact: William JACOT, MD PhD       William.Jacot@icm.unicancer.fr   
Principal Investigator: William JACOT, MD PhD         
Institut Curie (Paris hospital) Recruiting
Paris, France, 75005
Contact: François-Clément BIDARD, MD PhD       francois-clement.bidard@curie.fr   
Principal Investigator: François-Clément BIDARD, MD PhD         
Institut Mutualiste Montsouris Not yet recruiting
Paris, France, 75014
Contact: Christophe LOUVET, MD PhD         
Principal Investigator: Christophe LOUVET, MD PhD         
Institut Curie (St Cloud hospital) Recruiting
Saint-cloud, France, 92210
Contact: Jean-Yves PIERGA, MD PhD       jean-yves.pierga@curie.fr   
Principal Investigator: Jean-Yves PIERGA, MD PhD         
Sponsors and Collaborators
Institut Curie
Investigators
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Study Director: François-Clément BIDARD, MD PhD Institut Curie, Paris (FR)

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02866149     History of Changes
Other Study ID Numbers: IC 2015-02
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Curie:
Cancer
circulating tumor biomarkers
circulating tumor DNA
Circulating tumor Cell (CTC)

Additional relevant MeSH terms:
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Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action