Status:

RECRUITING

Study of Biomarkers in Gynecological Cancers

Lead Sponsor:

University Health Network, Toronto

Conditions:

Gynecologic Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

In recent years, there has been a significant improvement in understanding the biology of cancer and this information has been used to improve cancer care and patient outcome. Research has shown that...

Eligibility Criteria

Inclusion

  • Pre-Screening Eligibility:
  • Patients with probable diagnoses of gynecological malignancy (ovarian, tubal, primary peritoneal, uterine, cervical, vulvar and rare gynecological cancers) and confirmed to be undergoing upfront debulking surgery/radiation
  • Patient must be ≥16 years of age at the time of consent.
  • Ability to understand and provide written informed consent.
  • ECOG Performance Status ≤ 2.
  • Patient must consent to provide tissue sample from surgery and blood samples
  • Life expectancy ≥3 months.

Exclusion

  • Patients must be treatment naïve (no previous treatment of Neoadjuvant chemotherapy nor radiation for newly diagnosed disease)
  • Eligibility for Patients with Gynecological Diagnosis
  • Inclusion Criteria:
  • Patients with histological confirmation of gynecological malignancy (except ovarian cancer with high grade serous histology, tubal, primary peritoneal, uterine, cervical, vulvar and vaginal cancer and rare gynecological cancers).
  • Patient must be ≥16 years of age at the time of consent.
  • Ability to understand and provide written informed consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
  • Patient must consent to providing archival tissue and/or to undergo tumour biopsy and/or to provide blood or fluid collection samples. Patients will also be asked to provide a blood sample for germline mutation analysis.
  • Life expectancy ≥3 months.
  • No limits of previous lines of treatment.

Key Trial Info

Start Date :

December 21 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 21 2027

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT03420118

Start Date

December 21 2017

End Date

December 21 2027

Last Update

December 5 2025

Active Locations (1)

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1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 1Z5