Congenital Uterine Anomalies: Identifying Cancer Associations and Genetic and Environmental Facto… (NCT04661072) | Clinical Trial Compass
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Congenital Uterine Anomalies: Identifying Cancer Associations and Genetic and Environmental Factors to Improve Clinical Care
United States300 participantsStarted 2021-07-14
Plain-language summary
The purpose of this research study is to learn more about the health outcomes associated with congenital uterine anomalies (CUAs), and the possible environmental and genetic causes of the condition. The researchers plan to investigate whether any cancer associations (with breast, renal, ovarian, vaginal and uterine cancers) exist in females with CUAs. The investigator will also investigate any environmental and genetic factors that may be responsible for causing CUAs.
Who can participate
Age range
13 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of breast cancer in women with CUA's compared to women without CUA's
Timeframe: 6-months
2
Prevalence of ovarian cancer in women with CUA's compared to women without CUA's
Timeframe: 6-months
3
Prevalence of uterine cancer in women with CUA's compared to women without CUA's
Timeframe: 6-months
4
Prevalence of cervical cancer in women with CUA's compared to women without CUA's
Timeframe: 6 month
5
Prevalence of vaginal cancer in women with CUA's compared to women without CUA's
Timeframe: 6 month
6
Prevalence of renal cancer in women with CUA's compared to women without CUA's