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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)

NCT03017573 — Not applicable, Recruiting, 1050 participants, Institut Curie

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RegistryNCT03017573, acronym SCANDARE
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, basic science
Enrollment1050 (Estimated)
SponsorInstitut Curie (Other)
ConditionsOvarian Cancer, Triple-Negative Breast Cancer, Head and Neck Cancer, Cervical Cancer, Sarcoma, Vulva Cancer
InterventionsTumor biopsies / Tumor surgery, Blood withdrawal (Procedure)
Datesstart 2017-01-06, primary completion 2029-08-06 (estimated), completion 2032-01-06 (estimated), first posted 2017-01-11, last updated 2026-02-03
Locations6 sites in France

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-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. 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.

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+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)

+Arms and interventions

ArmTypeInterventionsDescription
Tumor and blood samplingExperimentalProcedure: Tumor biopsies / Tumor surgery; Procedure: Blood withdrawalPatients will have a biopsy or a surgery and blood sampling at different time points.
  • Tumor biopsies / Tumor surgery (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 (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

+Outcome measures

Primary outcomes

  • Correlation between tumor molecular/immunological profile and Baseline clinicobiological features [up to 6 months]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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 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).
   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

+Locations (6)

FacilityCityCountryStatus
Institut BergonieBordeauxFranceRecruiting
Centre Oscar LambretLilleFranceRecruiting
Centre Leon BerardLyonFranceRecruiting
Institut CurieParisFranceRecruiting
Institut Curie Hopital Rene HugueninSaint-CloudFranceRecruiting
Institut de Cancérologie de Lorraine - NancyVandœuvre-lès-NancyFranceNot yet recruiting

+Publications

  • Results publication: 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. PMID 39612700
  • Results publication: 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. PMID 35418195

+Investigators

  • Edith BORCOMAN, Prof., Principal investigator, Institut Curie

My Notes