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)

• ClinicalTrials.gov Identifier: NCT03017573
• Recruitment Status: Recruiting
• First Posted: January 11, 2017
• Last Update Posted: April 11, 2024
• Sponsor: Institut Curie
• Information provided by (Responsible Party): Institut Curie

Tracking Information

• First Submitted Date: January 9, 2017
• First Posted Date: January 11, 2017
• Last Update Posted Date: April 11, 2024
• Actual Study Start Date: January 6, 2017
• Estimated Primary Completion Date: August 2028 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 9, 2017): Correlation between tumor molecular/immunological profile and Baseline clinicobiological features [ Time Frame: up to 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 19, 2023)

• Correlation between disease recurrence and molecular and/or immunological biomarkers [ Time Frame: up to 24 months ]
• Correlation between genomic alterations and immune parameters [ Time Frame: up to 24 months ]
• Correlation between mutations load and immune parameters [ Time Frame: up to 24 months ]
• Correlation between ctDNA levels, de novo mutations in ctDNA and immune [ Time Frame: 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 ]

Original Secondary Outcome Measures (submitted: January 9, 2017)

• Correlation between disease recurrence and molecular and/or immunological biomarkers [ Time Frame: up to 24 months ]
• Correlation between genomic alterations and immune parameters [ Time Frame: up to 24 months ]
• Correlation between mutations load and immune parameters [ Time Frame: up to 24 months ]
• Correlation between ctDNA levels, de novo mutations in ctDNA and immune [ Time Frame: up to 24 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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)
• 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)
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Ovarian Cancer
• Triple-Negative Breast Cancer
• Head and Neck Cancer
• Cervical Cancer

Intervention

• 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

Study Arms

Experimental: Tumor and blood sampling

Patients will have a biopsy or a surgery and blood sampling at different time points.

Interventions:

• Procedure: Tumor biopsies / Tumor surgery
• Procedure: Blood withdrawal

• Publications *: Hoffmann C, Noel F, Grandclaudon M, Massenet-Regad L, Michea P, Sirven P, Faucheux L, Surun A, Lantz O, Bohec M, Ye J, Guo W, Rochefort J, Klijanienko J, Baulande S, Lecerf C, Kamal M, Le Tourneau C, Guillot-Delost M, Soumelis V. PD-L1 and ICOSL discriminate human Secretory and Helper dendritic cells in cancer, allergy and autoimmunity. Nat Commun. 2022 Apr 13;13(1):1983. doi: 10.1038/s41467-022-29516-w.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 13, 2021): 700
• Original Estimated Enrollment (submitted: January 9, 2017): 500
• Estimated Study Completion Date: January 6, 2031
• Estimated Primary Completion Date: August 2028 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Anne-Sophie PLISSONNIER; 01 47 11 23 78; drci.promotion@curie.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03017573
• Other Study ID Numbers: IC 2016-03
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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
• Supporting Materials: 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).

• Current Responsible Party: Institut Curie
• Original Responsible Party: Same as current
• Current Study Sponsor: Institut Curie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Institut Curie
• Verification Date: April 2024