AzTrials
AzTrials

Ovarian CancerSCANDARENCT03017573

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)

A study testing Tumor biopsies / Tumor surgery and Blood withdrawal in people with Ovarian Cancer and Triple-Negative Breast Cancer, run by Institut Curie at 6 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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, advanced stage treatment-naïve cervical or vulva cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tumor biopsies / Tumor surgery and Blood withdrawal
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
6 sitesFrance
Study dates
6 Jan 2017to 6 Jan 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 vulva cancer (all types) or cervical cancer patients with (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2).
  • Newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment
  • Male or female patients ≥ 18 years of age
  • Signed informed consent

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anne-Sophie PLISSONNIER contact

01 47 11 23 78

drci.promotion@curie.fr

6 sites in 1 country

France6 sites, 6 recruiting

  • Institut Bergonie

    Bordeaux, 33076

    Adeline PETIT, MD, A.Petit@.bordeaux.unicancer.fr

    Adeline PETIT, MD

    Recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Camille PASQUESOONE, MD, c.pasquesoone@o-lambret.fr

    Camille PASQUESOONE, MD

    Recruiting

  • Centre Leon Berard

    Lyon, 69373

    Nicolas CHOPIN, MD

    nicolas.chopin@lyon.unicancer.fr

    Recruiting

  • Institut Curie

    Paris, 75005

    Edith BORCOMAN, MD, edith.borcoman@curie.fr

    Edith BORCOMAN, MD

    Recruiting

  • Institut Curie Hopital Rene Huguenin

    Saint-Cloud, 92210

    Nicolas POUGET, MD, nicolas.pouget@curie.fr

    Nicolas POUGET, MD

    Recruiting

  • Institut de Cancérologie de Lorraine - Nancy

    Vandœuvre-lès-Nancy

    Romina MASTRONICOLA, M, r.mastronicola@nancy.unicancer.fr

    Romina MASTRONICOLA, MD

    Not yet recruiting

Other trials in France

About this study

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 or vulva 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.

Read the 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)
  1. 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)
Being tested
Tumor biopsies / Tumor surgery, Blood withdrawal
Keywords
Immunological biomarkers, molecular profil, Circulating tumor DNA (ctDNA)
Medical subject headings
Ovarian Neoplasms, Triple Negative Breast Neoplasms, Head and Neck Neoplasms, Uterine Cervical Neoplasms, Sarcoma, Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor biopsies / Tumor surgeryProcedure or 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)

  • Blood withdrawalProcedure or surgery

    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 groups in NCT03017573
Study groupRoleWhat they receive
Tumor and blood samplingExperimentalPatients will have a biopsy or a surgery and blood sampling at different time points.
Receives: Procedure: Tumor biopsies / Tumor surgery; Procedure: Blood withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between tumor molecular/immunological profile and Baseline clinicobiological features

    Measured: up to 6 months

Secondary outcomes (5)

  1. Correlation between disease recurrence and molecular and/or immunological biomarkers

    Measured: up to 24 months

  2. Correlation between genomic alterations and immune parameters

    Measured: up to 24 months

  3. Correlation between mutations load and immune parameters

    Measured: up to 24 months

  4. Correlation between ctDNA levels, de novo mutations in ctDNA and immune

    Measured: up to 24 months

  5. For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study start6 Jan 2017
  3. Primary completion6 Aug 2029 (estimated)
  4. Study completion6 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,050 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017573
Sponsor's protocol ID
IC 2016-03
Acronym
SCANDARE
Status last verified
Jan 2026
First submitted
9 Jan 2017
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Publications

  • Marret G, Lamy C, Vacher S, Cabel L, Sene M, Ahmanache L, Courtois L, El Beaino Z, Klijanienko J, Martinat C, Servant N, Kamoun C, Halladjian M, Bronzini T, Balsat C, Laes JF, Prevot A, Sauvage S, Lienard M, Martin E, Genin B, Badois N, Lesnik M, Dubray-Vautrin A, Choussy O, Ghanem W, Taouachi R, Planchon JM, Bieche I, Le Tourneau C, Kamal M. Deciphering molecular relapse and intra-tumor heterogeneity in non-metastatic resectable head and neck squamous cell carcinoma using circulating tumor DNA. Oral Oncol. 2025 Jan;160:107111. doi: 10.1016/j.oraloncology.2024.107111. Epub 2024 Nov 29.

    PubMed 39612700

  • 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.

    PubMed 35418195

Questions about this trial

What is this clinical trial studying?

A study testing Tumor biopsies / Tumor surgery and Blood withdrawal in people with Ovarian Cancer and Triple-Negative Breast Cancer, run by Institut Curie at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne-Sophie PLISSONNIER (01 47 11 23 78, drci.promotion@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between tumor molecular/immunological profile and Baseline clinicobiological features (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017573, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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