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

NCT ID: NCT03017573

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-06

Study Completion Date

2032-01-06

Brief Summary

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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, advanced stage treatment-naïve cervical cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. 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

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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)

Conditions

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

Keywords

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Immunological biomarkers molecular profil Circulating tumor DNA (ctDNA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tumor and blood sampling

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

Group Type EXPERIMENTAL

Tumor biopsies / Tumor surgery

Intervention Type PROCEDURE

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)

Blood withdrawal

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
5. Newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment
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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe LE TOURNEAU, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

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Institut Bergonie

Bordeaux, , France

Site Status RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status RECRUITING

Centre Leon Berard

Lyon, , France

Site Status RECRUITING

Institut Curie

Paris, , France

Site Status RECRUITING

Institut Curie Hopital Rene Huguenin

Saint-Cloud, , France

Site Status RECRUITING

Institut de Cancérologie de Lorraine - Nancy

Vandœuvre-lès-Nancy, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Anne-Sophie PLISSONNIER

Role: CONTACT

Phone: 01 47 11 23 78

Email: [email protected]

Facility Contacts

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Adeline PETIT, MD

Role: primary

Camille PASQUESOONE, MD

Role: primary

Nicolas CHOPIN, MD

Role: primary

Role: backup

Edith BORCOMAN, MD

Role: primary

Nicolas POUGET, MD

Role: primary

Romina MASTRONICOLA, M

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35418195 (View on PubMed)

Other Identifiers

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IC 2016-03

Identifier Type: -

Identifier Source: org_study_id