Endometrial CancerNCT05877404
Practice Patterns Among Gynecologic Oncologists on Tumor Genetic Testing in Endometrial Cancer
An observational study of Endometrial Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Surveys
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Gynecologic Oncologists and gynecologic oncology fellows-in-training from around the world, who are members of the Society of Gynecologic Oncology (SGO).
Who may be able to join
- Member of the Society of Gynecologic Oncology
- Gynecologic Oncologist or Gynecologic Oncology Fellow-in-Training
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- Surveys
- Keywords
- Genetic testing
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Survey on practice patterns surrounding tumor genetic testing in endometrial cancer.
| Study group | Role | What they receive |
|---|---|---|
| Gynecologic Oncologists | Gynecologic Oncologists and gynecologic oncology fellows-in-training from around the world, who are members of the Society of Gynecologic Oncology (SGO). Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of providers reporting the use of different tumor genetic testing strategies among newly diagnosed endometrial cancer patients
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.
Measured: 4 months
Secondary outcomes (3)
Frequency of providers using different strategies of informed consent in tumor genetic testing in endometrial cancer
Investigators will calculate the number of frequencies of different tumor testing informed consent strategies among physicians.
Measured: 4 months
Number of providers reporting confidence in utilizing tumor genetic testing to guide treatment decisions
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.
Measured: 4 months
Number of providers who change their counseling or testing strategies for endometrial cancer
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start15 Aug 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Why it stopped: This was a national survey of physicians. Per the protocol, they were only allowed to be contacted twice and they received less surveys back than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Weaver, PhD, MPH, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877404
- Sponsor's protocol ID
- IRB00097221
- Other IDs
- WFBCCC 99323, P30CA012197, NCI-2023-05554
- Status last verified
- Apr 2024
- First submitted
- 17 May 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Patterns Among Gynecologic Oncologists on Tumor Genetic Testing in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05877404
- Acronym / sponsor ID
- IRB00097221
- Conditions
- Endometrial Cancer
- Keywords
- Genetic testing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This was a national survey of physicians. Per the protocol, they were only allowed to be contacted twice and they received less surveys back than anticipated.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecologic Oncologists | – | Other: SurveysGynecologic Oncologists and gynecologic oncology fellows-in-training from around the world, who are members of the Society of Gynecologic Oncology (SGO). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Gynecologic Oncologists and gynecologic oncology fellows-in-training from around the world, who are members of the Society of Gynecologic Oncology (SGO).
Key inclusion criteria (2 listed)
- Member of the Society of Gynecologic Oncology
- Gynecologic Oncologist or Gynecologic Oncology Fellow-in-Training
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysSurvey on practice patterns surrounding tumor genetic testing in endometrial cancer. | Other | Gynecologic Oncologists |
Primary outcome
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.
3 secondary outcomes
Frequency of providers using different strategies of informed consent in tumor genetic testing in endometrial cancer
Time frame: 4 months
Number of providers reporting confidence in utilizing tumor genetic testing to guide treatment decisions
Time frame: 4 months
Number of providers who change their counseling or testing strategies for endometrial cancer
Time frame: 4 months
Results and safety
The study was stopped early (reason given: This was a national survey of physicians. Per the protocol, they were only allowed to be contacted twice and they received less surveys back than anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Weaver, PhD, MPH principal investigator
Wake Forest Baptist Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This was a national survey of physicians. Per the protocol, they were only allowed to be contacted twice and they received less surveys back than anticipated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of providers reporting the use of different tumor genetic testing strategies among newly diagnosed endometrial cancer patients (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.