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NCT Number: NCT03017573

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)

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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Key information

Conditions

Ovarian Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Cervical Cancer Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Ovarian Diseases Ovarian Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms Triple-negative Breast Cancer Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vulva Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonie, Bordeaux, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 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

Treatment and study plan

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

Primary outcomes

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

    Time frame: up to 6 months

Secondary outcomes

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

    Time frame: up to 24 months

  2. Correlation between genomic alterations and immune parameters

    Time frame: up to 24 months

  3. Correlation between mutations load and immune parameters

    Time frame: up to 24 months

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

    Time frame: up to 24 months

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

    Time frame: up to 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Sophie PLISSONNIER

CONTACT

[email protected]

01 47 11 23 78

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: SCANDARE

Important dates

Study start
2017
Primary completion
2029
Study completion
2032
First posted
Jan 11, 2017
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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