- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05877404
Practice Patterns Among Gynecologic Oncologists on Tumor Genetic Testing in Endometrial Cancer
April 17, 2024 updated by: Wake Forest University Health Sciences
In order to formulate strategies to improve adherence to best practice guidelines, as well as utilization of novel therapies, investigators must understand current practice patterns surrounding tumor genetic testing in endometrial cancer.
The aim is to survey a representative sample of gynecologic oncologists who belong to the society of gynecologic oncology, via an email survey, to better understand current practices surrounding tumor genetic testing as well as determine if there have been any changes to practice since the publication of recent trials on the use of immune-checkpoint inhibitors in endometrial cancer.
Study Overview
Detailed Description
Primary Objective: Proportion of physicians reporting the use of different tumor genetic testing strategies among newly diagnosed endometrial cancer patients.
Secondary Objectives:
- Explore the use of informed consent in tumor genetic testing in endometrial cancer
- Explore clinician confidence in utilizing tumor genetic testing to guide treatment decisions.
- Explore the impact of recent publications regarding immunotherapy on the use of tumor genetic testing in endometrial cancer.
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Gynecologic Oncologists and gynecologic oncology fellows-in-training from around the world, who are members of the Society of Gynecologic Oncology (SGO).
Description
Inclusion Criteria:
- Member of the Society of Gynecologic Oncology
- Gynecologic Oncologist or Gynecologic Oncology Fellow-in-Training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gynecologic Oncologists
Gynecologic Oncologists and gynecologic oncology fellows-in-training from around the world, who are members of the Society of Gynecologic Oncology (SGO).
|
Survey on practice patterns surrounding tumor genetic testing in endometrial cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of providers reporting the use of different tumor genetic testing strategies among newly diagnosed endometrial cancer patients
Time Frame: 4 months
|
The primary outcome is to estimate the percentage of providers who report the use of different tumor testing strategies.
Investigators will calculate the frequencies of responses to each testing strategy and then compare the percentage of physicians who choose different strategies, using a chi-square or Fisher's exact test.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of providers using different strategies of informed consent in tumor genetic testing in endometrial cancer
Time Frame: 4 months
|
Investigators will calculate the number of frequencies of different tumor testing informed consent strategies among physicians.
|
4 months
|
Number of providers reporting confidence in utilizing tumor genetic testing to guide treatment decisions
Time Frame: 4 months
|
Investigators will calculate the number of providers who are very confident, moderately confident, a little confident or not at all confident in their ability to explain tumor testing strategies and results.
|
4 months
|
Number of providers who change their counseling or testing strategies for endometrial cancer
Time Frame: 4 months
|
Investigators will compare the number of providers who have changed their counseling or testing strategy based on their familiarity with recent publications regarding immune-checkpoint inhibitors in advanced and recurrent endometrial cancer using a chi-square or Fisher's exact test.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kathryn Weaver, PhD, MPH, Wake Forest Baptist Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2023
Primary Completion (Actual)
February 28, 2024
Study Completion (Actual)
February 28, 2024
Study Registration Dates
First Submitted
May 17, 2023
First Submitted That Met QC Criteria
May 17, 2023
First Posted (Actual)
May 26, 2023
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00097221
- P30CA012197 (U.S. NIH Grant/Contract)
- WFBCCC 99323 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)
- NCI-2023-05554 (Other Identifier: CTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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