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Status:

UNKNOWN

Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma

Lead Sponsor:

Institut Paoli-Calmettes

Collaborating Sponsors:

AstraZeneca

Conditions:

Ovarian Carcinoma

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

Detailed Description

The main objective is to explore the capacity of ctDNA to be an early marker of ovarian carcinoma recurrence after front-line treatments, i.e. to show significant modifications before clinical diagnos...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy.
  • Indication of preoperative and/or adjuvant chemotherapy.
  • Age ≥ 18 years old.
  • Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
  • Signed written informed consent prior to any screening procedures being performed
  • Non inclusion Criteria:
  • Contraindication to surgical assessment.
  • Pathological diagnosis of mucinous carcinoma.
  • History of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer).
  • Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol.
  • Patient in urgency situation, adult under legal protection, or unable to give his consent.
  • Exclusion Criteria after histological exam:
  • Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.

Exclusion

    Key Trial Info

    Start Date :

    October 10 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 30 2023

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT03302884

    Start Date

    October 10 2018

    End Date

    October 30 2023

    Last Update

    September 26 2019

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Centre Jean Perrin

    Clermont-Ferrand, France, 63011

    2

    Centre Oscar Lambret

    Lille, France, 59000

    3

    Institut Du Cancer de Montpellier

    Montpellier, France, 34298