RecruitingNot ApplicableNCT03017573

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)


Sponsor

Institut Curie

Enrollment

1,050 participants

Start Date

Jan 6, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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

Exclusion Criteria4

  • 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

Interventions

PROCEDURETumor 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)

PROCEDUREBlood 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


Locations(6)

Institut Bergonie

Bordeaux, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Institut Curie

Paris, France

Institut Curie Hopital Rene Huguenin

Saint-Cloud, France

Institut de Cancérologie de Lorraine - Nancy

Vandœuvre-lès-Nancy, France

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NCT03017573


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