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)
Primary Purpose
Ovarian Cancer, Triple-Negative Breast Cancer, Head and Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tumor biopsies / Tumor surgery
Blood withdrawal
Sponsored by
About this trial
This is an interventional basic science trial for Ovarian Cancer focused on measuring Immunological biomarkers, molecular profil, Circulating tumor DNA (ctDNA)
Eligibility Criteria
Inclusion Criteria:
Tumor types :
- Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy
- Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy
- Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery
- Male or female patients ≥ 18 years of age
- Signed informed consent
Exclusion Criteria:
- Male or female patients ≤18 years old
- Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Individually deprived of liberty or placed under the authority of a tutor
- Patients not affiliated to the Social Security System
Sites / Locations
- Institut Bergonie
- Centre Oscar Lambret
- Centre Leon Berard
- Institut CurieRecruiting
- Institut Curie Hopital Rene HugueninRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tumor and blood sampling
Arm Description
Patients will have a biopsy or a surgery and blood sampling at different time points.
Outcomes
Primary Outcome Measures
Correlation between tumor molecular/immunological profile and Baseline clinicobiological features
Secondary Outcome Measures
Correlation between disease recurrence and molecular and/or immunological biomarkers
Correlation between genomic alterations and immune parameters
Correlation between mutations load and immune parameters
Correlation between ctDNA levels, de novo mutations in ctDNA and immune
For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03017573
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)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2017 (Actual)
Primary Completion Date
August 2028 (Anticipated)
Study Completion Date
January 6, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 :
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)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Triple-Negative Breast Cancer, Head and Neck Cancer, Cervical Cancer
Keywords
Immunological biomarkers, molecular profil, Circulating tumor DNA (ctDNA)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tumor and blood sampling
Arm Type
Experimental
Arm Description
Patients will have a biopsy or a surgery and blood sampling at different time points.
Intervention Type
Procedure
Intervention Name(s)
Tumor biopsies / Tumor surgery
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Blood withdrawal
Intervention Description
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
Primary Outcome Measure Information:
Title
Correlation between tumor molecular/immunological profile and Baseline clinicobiological features
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Correlation between disease recurrence and molecular and/or immunological biomarkers
Time Frame
up to 24 months
Title
Correlation between genomic alterations and immune parameters
Time Frame
up to 24 months
Title
Correlation between mutations load and immune parameters
Time Frame
up to 24 months
Title
Correlation between ctDNA levels, de novo mutations in ctDNA and immune
Time Frame
up to 24 months
Title
For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tumor types :
Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy
Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy
Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery
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).
Male or female patients ≥ 18 years of age
Signed informed consent
Exclusion Criteria:
Male or female patients ≤18 years old
Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Individually deprived of liberty or placed under the authority of a tutor
Patients not affiliated to the Social Security System
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sophie PLISSONNIER
Phone
01 47 11 23 78
Email
drci.promotion@curie.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe LE TOURNEAU, Prof.
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric GUYON, MD
Email
f.guyon@unicancer.bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Frédéric GUYON, MD
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille PASQUESOONE, MD
Email
c.pasquesoone@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Camille PASQUESOONE, MD
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas CHOPIN, MD
Email
nicolas.chopin@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Nicolas CHOPIN, MD
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe LE TOURNEAU, MD
Email
christophe.letourneau@curie.fr
First Name & Middle Initial & Last Name & Degree
Christophe LE TOURNEAU, MD
Facility Name
Institut Curie Hopital Rene Huguenin
City
Saint-cloud
ZIP/Postal Code
92210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas POUGET, MD
Email
nicolas.pouget@curie.fr
First Name & Middle Initial & Last Name & Degree
Nicolas POUGET, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35418195
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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