Investigating cancer links and causes in women with congenital uterine anomalies
Congenital Uterine Anomalies: Identifying Cancer Associations and Genetic and Environmental Factors to Improve Clinical Care
This study is trying to see if women with certain uterine conditions are more likely to get different types of cancer and what factors might be involved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 13 Years and up |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04661072 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the health outcomes of women diagnosed with congenital uterine anomalies (CUAs) and to identify potential genetic and environmental factors contributing to these conditions. Researchers will assess the prevalence of various cancers, including breast, renal, ovarian, vaginal, and uterine cancers, in this population. The study will involve collecting blood samples for genetic analysis and conducting surveys to gather information on environmental exposures. The goal is to enhance clinical care by understanding the associations between CUAs and cancer risk.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 13 and older who have been diagnosed with any variation of congenital uterine anomaly.
Not a fit: Patients who decline to participate or are unable to provide informed consent due to mental disability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved clinical care and risk assessment for women with congenital uterine anomalies.
How similar studies have performed: While there have been studies investigating cancer associations with congenital anomalies, this specific approach focusing on CUAs and their potential genetic and environmental factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * females * age: 13 or older * encounters limited to: Yale New Haven Hospital, Bridgeport Hospital, Greenwich Hospital and Lawrence+ Memorial Hospital. * diagnosis of any variation of CUA Exclusion Criteria: * who will decline to participate in a study upon contact * non-English speaking except Spanish speaking * unable to participate in consent or assent process due to mental disability
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Alla Vash-Margita, MD — Yale University
- Study coordinator: Alla Vash-Margita, MD
- Email: alla.vash-margita@yale.edu
- Phone: 203-785-4010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.