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NCT06239766 · ClinicalTrials.gov registry record
BC Risk Assessment Before Top Surgery
A clinical trial, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- 25
- Enrollment target
NCT06239766: Completed study, sponsored by Medical College of Wisconsin.
NCT06239766 is a clinical trial that has completed, run by Medical College of Wisconsin. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06239766 has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
The population of transgender and gender-diverse (TGD) persons in Wisconsin and the U.S. is steadily increasing. As this population grows, the number of individuals seeking gender-affirming therapies, including gender-affirming operations and gender-affirming hormone therapy, is also growing. An example of gender-affirming surgery is chest masculinization surgery, in which most breast tissue is removed in a person assigned female or intersex at birth to allow the chest to appear masculine. Gender-affirming chest masculinization surgery is not generally considered equivalent to an oncologic mastectomy, which aims to removal all breast tissue for future breast cancer reduction or current breast cancer treatment. The goals of this investigation are to 1) determine the percent of TGD persons considering chest masculinization surgery who have an elevated lifetime risk of breast cancer development and/or a pathogenic genetic mutation; 2) measure the percent who are at risk and choose to undergo risk-reducing mastectomies as part of chest masculinization surgery; and 3) assess and compare self-perceived breast cancer risk with calculated risk. The results of this study will substantially inform TGD patients and surgeons on the utility of personalized breast cancer risk assessment prior to chest masculinization surgery and the accuracy of self-perceived breast cancer risk in TGD persons.
Primary Outcome
Validated breast cancer risk calculators (IBIS and Gail) will be used to determine lifetime breast cancer risk of participants enrolled into the study. Ranges and 95% CI will be made to estimate the percent of TGD persons at risk.
Interventions
- DIAGNOSTIC_TEST Breast Cancer Risk Assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2024-02-01 |
What the finished NCT06239766 record still lists
NCT06239766 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Breast Cancer Risk Assessment is the first listed.
NCT06239766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06239766 about?
NCT06239766 is a clinical study titled "BC Risk Assessment Before Top Surgery". The population of transgender and gender-diverse (TGD) persons in Wisconsin and the U.S. is steadily increasing. As this population grows, the number of individuals seeking gender-affirming therapies, including gender-affirming operations and gender-affirming hormone therapy, is also growing. An exa...
What is the current status of trial NCT06239766?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2023-03-15. Estimated completion is 2024-02-01.
What interventions are being tested in trial NCT06239766?
The interventions under investigation include: Breast Cancer Risk Assessment (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06239766?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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