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Prospective Biobanking Study in Ovarian, Breast and Head and Neck Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE) (SCANDARE)

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ClinicalTrials.gov Identifier: NCT03017573
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief Summary:
SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast and head and neck cancer patients. This study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Triple-Negative Breast Cancer Head and Neck Cancer Procedure: Tumor biopsies / Tumor surgery Procedure: Blood withdrawal Not Applicable

Detailed Description:

Patients will have blood and +/- tumor samples at the following times :

  1. if eligible for surgery :

    • at surgery (blood + tumor and nodes)
    • after surgery (blood)
    • before cycle 1 of adjuvant chemotherapy (blood + tumor biopsie and nodes if possible)
    • before cycle 2 of adjuvant chemotherapy (blood)
    • at progression (blood + tumor biopsie and nodes if possible)
  2. if eligible for neoadjuvant chemotherapy :

    • before neoadjuvant therapy (blood + tumor biopsie and nodes)
    • during neoadjuvant therapy (post cycle 1) (blood)
    • at the time of surgery (blood + tumor and nodes)
    • before cycle 1 of adjuvant chemotherapy (blood + tumor biopsie and nodes)
    • before cycle 2 of adjuvant chemotherapy (blood)
    • at progression (blood + tumor biopsie and nodes)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prospective Biobanking Study in Ovarian, Breast and Head and Neck Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Tumor and blood sampling
Patients will have a biopsy or a surgery and blood sampling at different time points.
Procedure: Tumor biopsies / Tumor surgery

Tumoral tissues samples must be collected at different times points :

  • at the time of surgery
  • before first cycle of adjuvant treatment (if possible)
  • at progression (if possible)

OR

  • before neoadjuvant therapy
  • at the time of surgery
  • before first cycle of adjuvant treatment (if possible)
  • at progression (if possible)

Procedure: Blood withdrawal

Blood samples must be collected at different times points :

  • at the time of surgery
  • after surgery
  • before first cycle of adjuvant treatment
  • before second cycle of adjuvant treatment
  • at progression

OR

  • before neoadjuvant therapy
  • during neoadjuvant therapy (post cycle 1)
  • at the time of surgery
  • before first cycle of adjuvant treatment
  • before second cycle of adjuvant treatment
  • at progression




Primary Outcome Measures :
  1. Correlation between tumor molecular/immunological profile and Baseline clinicobiological features [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Correlation between disease recurrence and molecular and/or immunological biomarkers [ Time Frame: up to 24 months ]
  2. Correlation between genomic alterations and immune parameters [ Time Frame: up to 24 months ]
  3. Correlation between mutations load and immune parameters [ Time Frame: up to 24 months ]
  4. Correlation between ctDNA levels, de novo mutations in ctDNA and immune [ Time Frame: up to 24 months ]


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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. Tumor types :

    1. Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy
    2. Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy
    3. Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery
  2. Male or female patients ≥ 18 years of age
  3. Signed informed consent

Exclusion Criteria:

  1. Male or female patients ≤18 years old
  2. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  3. Individually deprived of liberty or placed under the authority of a tutor
  4. Patients not affiliated to the Social Security System

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): NCT03017573


Contacts
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Contact: Anne-Sophie PLISSONNIER 01 56 24 56 30 chrystelle.gastrin@curie.fr

Locations
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France
Institut Curie Recruiting
Paris, France, 75005
Contact: Christophe LE TOURNEAU, MD       christophe.letourneau@curie.fr   
Principal Investigator: Christophe LE TOURNEAU, MD         
Institut Curie Hopital Rene Huguenin Recruiting
Saint-cloud, France, 92210
Contact: Nicolas POUGET, MD       nicolas.pouget@curie.fr   
Principal Investigator: Nicolas POUGET, MD         
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Christophe LE TOURNEAU, Prof. Institut Curie

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03017573     History of Changes
Other Study ID Numbers: IC 2016-03
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Curie:
Immunological biomarkers
molecular profil
Circulating tumor DNA (ctDNA)

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Neoplasms
Breast Diseases
Skin Diseases