NCT04661072|RecruitingDMC
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Sponsor study identifier
Secondary identifiers
observational
300
1 country
1
Study Start
July 14, 2021
Actual (reported)Primary Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2020
Actual (reported)December 9, 2020
Actual (reported)July 14, 2021
Actual (reported)August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prevalence of breast cancer in women with CUA's compared to women without CUA's
Prevalence of breast cancer in women with CUA's compared to women without CUA's will be measured
6-months
Prevalence of ovarian cancer in women with CUA's compared to women without CUA's
Prevalence of ovarian cancer in women with CUA's compared to women without CUA's will be measured
6-months
Prevalence of uterine cancer in women with CUA's compared to women without CUA's
Prevalence of uterine cancer in women with CUA's compared to women without CUA's will be measured
6-months
Prevalence of cervical cancer in women with CUA's compared to women without CUA's
Prevalence of cervical cancer in women with CUA's compared to women without CUA's will be measured
6 month
Prevalence of vaginal cancer in women with CUA's compared to women without CUA's
Prevalence of vaginal cancer in women with CUA's compared to women without CUA's will be measured
6 month
Whole exome sequencing (WES) and microarray
24 months
The rates of renal, breast, uterine, ovarian and vaginal cancers in women who have been diagnosed with a CUA will be studies
Women and girls who have received care within the Yale New Haven Health system and have a CUA diagnosis Anticipated number - approximately 300 subjects Age range - from 13 years old and older Health status - able to participate in consent and assent (based on age) process
Yale University
New Haven, Connecticut, 06511, United States
Following informed consent, blood will be collected for genetic evaluation. DNA will be extracted from EDTA-blood and analyzed using an integrated approach of microarray for copy number variations (CNV), and Whole Exome Sequencing (WES) for Single Nucleotide Variation (SNV).
Alla Vash-Margita, MD
Yale University
Emanuele Pelosi, MD
Yale University
First Submitted
December 8, 2020
First Posted
December 9, 2020
Study Start
July 14, 2021
Actual (reported)Primary Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prevalence of renal cancer in women with CUA's compared to women without CUA's
Prevalence of renal cancer in women with CUA's compared to women without CUA's will be measured
6 month
Contact the study team to confirm eligibility.
Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 9, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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