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Biomarker Analysis for Gynecologic Cancers

N/A
Recruiting
Led By Amit Oza, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be ≥16 years of age at the time of consent.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying gene changes or protein expression of tumors in women with gynecologic cancer.

Who is the study for?
This study is for individuals with probable gynecological cancers (like ovarian, uterine, cervical) who are set to undergo surgery or radiation. Participants must understand the study and agree in writing, have a life expectancy of at least 3 months, be willing to provide tissue and blood samples for research, be 16 years or older, and have an ECOG Performance Status of 2 or less.
What is being tested?
The trial involves collecting tumor tissue during surgery and drawing blood from patients with gynecological cancers. Researchers aim to learn about gene changes or protein levels in tumors to improve understanding of cancer behavior and treatment responses.
What are the potential side effects?
Since this trial does not involve testing new drugs but rather collects data through tissue collection and blood draws, typical side effects associated with drug interventions are not expected. However, there may be general risks related to surgical procedures and discomfort from blood draws.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 16 years old or older.
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I have a gynecological cancer and am confirmed for initial major surgery or radiation.
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I can take care of myself and perform daily activities.
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I agree to give tissue and blood samples for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tumor tissue and blood samples collectionExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood draws
2010
Completed Phase 2
~520

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
502,672 Total Patients Enrolled
5 Trials studying Gynecologic Cancers
908 Patients Enrolled for Gynecologic Cancers
Amit Oza, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
10 Previous Clinical Trials
831 Total Patients Enrolled
1 Trials studying Gynecologic Cancers
510 Patients Enrolled for Gynecologic Cancers

Media Library

Tumour tissue collection Clinical Trial Eligibility Overview. Trial Name: NCT03420118 — N/A
Gynecologic Cancers Research Study Groups: Tumor tissue and blood samples collection
Gynecologic Cancers Clinical Trial 2023: Tumour tissue collection Highlights & Side Effects. Trial Name: NCT03420118 — N/A
Tumour tissue collection 2023 Treatment Timeline for Medical Study. Trial Name: NCT03420118 — N/A
~6 spots leftby Dec 2024
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