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)

April 10, 2024 updated by: Institut Curie
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33076
      • Lille, France, 59000
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
        • Principal Investigator:
          • Camille PASQUESOONE, MD
      • Lyon, France, 69373
      • Paris, France, 75005
        • Recruiting
        • Institut Curie
        • Contact:
        • Principal Investigator:
          • Christophe LE TOURNEAU, MD
      • Saint-cloud, France, 92210
        • Recruiting
        • Institut Curie Hopital Rene Huguenin
        • Contact:
        • Principal Investigator:
          • Nicolas POUGET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between tumor molecular/immunological profile and Baseline clinicobiological features
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between disease recurrence and molecular and/or immunological biomarkers
Time Frame: up to 24 months
up to 24 months
Correlation between genomic alterations and immune parameters
Time Frame: up to 24 months
up to 24 months
Correlation between mutations load and immune parameters
Time Frame: up to 24 months
up to 24 months
Correlation between ctDNA levels, de novo mutations in ctDNA and immune
Time Frame: up to 24 months
up to 24 months
For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: Christophe LE TOURNEAU, Prof., Institut Curie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2017

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

January 6, 2031

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimated)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2016-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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