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Prospective Biobanking Study in Ovarian, Breast, Head and Neck and Cervical 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 : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
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Brief Summary:
SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, Head and Neck Cancer and Cervical 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 Cervical 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)
    • 6 months after surgery if non recurrence (Blood)
    • before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes if possible)
    • before cycle 2 of adjuvant chemotherapy or after radiotherapy (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)
    • 6 months after surgery if non recurrence (Blood)
    • before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes)
    • before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)
    • at progression (blood + tumor biopsie and nodes)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prospective Biobanking Study in Ovarian, Breast, Head and Neck and Cervical Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)
Actual Study Start Date : January 6, 2017
Estimated Primary Completion Date : August 2028
Estimated Study Completion Date : January 6, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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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 or before the beginning of chemoradiotherapy
  • after surgery or after chemoradiotherapy
  • 6 months after surgery if non recurrence
  • before first cycle of adjuvant treatment or before radiotherapy
  • before second cycle of adjuvant treatment or after radiotherapy
  • at progression

OR

  • before neoadjuvant therapy
  • during neoadjuvant therapy (post cycle 1)
  • at the time of surgery
  • 6 months after surgery if non recurrence
  • before first cycle of adjuvant treatment or before radiotherapy
  • before second cycle of adjuvant treatment or after radiotherapy
  • at progression


Outcome Measures
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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 ]
  5. For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence [ Time Frame: up to 24 months ]

Eligibility Criteria
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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. 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
    4. Newly diagnosed treatment-naïve cervical cancer patients (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2).
  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
Contacts and Locations
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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 47 11 23 78 drci.promotion@curie.fr

Locations
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France
Institut Bergonie Not yet recruiting
Bordeaux, France, 33076
Contact: Adeline PETIT, MD       A.Petit@.bordeaux.unicancer.fr   
Principal Investigator: Adeline PETIT, MD         
Centre Oscar Lambret Recruiting
Lille, France, 59000
Contact: Camille PASQUESOONE, MD       c.pasquesoone@o-lambret.fr   
Principal Investigator: Camille PASQUESOONE, MD         
Centre Leon Berard Not yet recruiting
Lyon, France, 69373
Contact: Nicolas CHOPIN, MD         
Contact       nicolas.chopin@lyon.unicancer.fr   
Principal Investigator: Nicolas CHOPIN, MD         
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03017573    
Other Study ID Numbers: IC 2016-03
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
Keywords provided by Institut Curie:
Immunological biomarkers
molecular profil
Circulating tumor DNA (ctDNA)
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
 Urogenital Neoplasms
Genital Diseases
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases