Recruiting NA Gynecologic Cancer

New treatment option for Gynecologic Cancer

Official title Study of Biomarkers in Gynecological Cancers

ClinicalTrials.gov ID: NCT03420118

What this study is testing

What it's testing
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 changes in some genes and/or proteins may be important indicators for certain cancers and response to treatments.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Pre-Screening Eligibility:
  • Patients with probable diagnoses of gynecological malignancy (ovarian, tubal, primary peritoneal, uterine, cervical, vulvar and rare gynecological...
  • Patient must be ≥16 years of age at the time of consent.
  • Ability to understand and provide written informed consent.
  • ECOG Performance Status ≤ 2.

You likely can't join if

  • Patients must be treatment naïve (no previous treatment of Neoadjuvant chemotherapy nor radiation for newly diagnosed disease) Eligibility for...
  • Patients with histological confirmation of gynecological malignancy (except ovarian cancer with high grade serous histology, tubal, primary...
  • 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...
See the full eligibility criteria
Who can join
  • 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...
  • 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.
What rules you out
  • 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...
  • 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. Exclusion Criteria:
  • Any contraindication to tumour biopsy or blood collection
  • Patient with diagnosis of High grade serous Ovarian Cancer are excluded

The study team makes the final eligibility decision.

Where it's taking place

  • Toronto, Ontario, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.