Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT04661072

Conditions

Congenital Uterine Anomaly

Eligibility Criteria

Sex: Female

Age: 13+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Congenital Uterine Anomaly

Study ID

NCT04661072

Start date

Jul 14, 2021

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 13+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Congenital Uterine Anomalies (CUA)

The rates of renal, breast, uterine, ovarian and vaginal cancers in women who have been diagnosed with a CUA will be studies

Primary outcome measure

  • Prevalence of breast cancer in women with CUA's compared to women without CUA's [ Time Frame: 6-months ]
  • Prevalence of ovarian cancer in women with CUA's compared to women without CUA's [ Time Frame: 6-months ]
  • Prevalence of uterine cancer in women with CUA's compared to women without CUA's [ Time Frame: 6-months ]
  • Prevalence of cervical cancer in women with CUA's compared to women without CUA's [ Time Frame: 6 month ]
  • Prevalence of vaginal cancer in women with CUA's compared to women without CUA's [ Time Frame: 6 month ]
  • Prevalence of renal cancer in women with CUA's compared to women without CUA's [ Time Frame: 6 month ]

Central Contacts and Locations

Central contacts

Alla Vash-Margita, MD

203-785-4010alla.vash-margita@yale.edu

Miranda Margetts, PhD

miranda.margetts@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Monica G Konstantino, RN

203-785-5816monica.konstantino@yale.edu

Principal Investigator:

Alla Vash-Margita, MD, FACOG

More Information

Sponsor

Yale University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Cancer associations
  • Environmental factors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-09.