An observational study in Abnormal Uterine Bleeding (AUB), Endometrial Cancer and Atypical Endometrial Hyperplasia, sponsored by Exact Sciences Corporation. Active, not recruiting at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Exact Sciences Corporation (part of Abbott) · Observational
This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
153 studies on the registry are indexed under Metrorrhagia; 35 are open to participants now.
This study's planned enrollment of 4,200 is above the median of 171 across 33 observational studies indexed under Metrorrhagia.
Browse Metrorrhagia studies →Exact Sciences Corporation is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
First submitted after Exact Sciences Corporation became part of Abbott.
Counted across the registry records on this site, refreshed daily.
Patients receiving routine clinical care within participating primary care, gynecology, oncology, and Veterans Affairs health systems across rural, urban, and suburban regions of the United States.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cohort 1 Participants:
Cohort 2 Participants:
Exclusion Criteria
Additional for Cohort 1:
Additional for Cohort 2:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergoing clinical evaluation for AUB
Participants diagnosed with EC or AEH/EIN
Collection of clinically characterized vaginal fluid specimens
Vaginal fluid specimens will be collected during a standard clinical exam using a swab-based collection method. Specimens will be used for research purposes to support the development of biomarker assays. No specific biomarkers or analytical methods are defined as part of this study.
Time frame: Within 90 days of enrollment.
Clinical data for biomarker assay development and evaluation
Clinical information will be collected as part of routine study participation and used to describe the study population and support research analyses. Data will be used in aggregate to contextualize research findings and inform future assay development.
Time frame: Within 90 days of enrollment
Collection devices for detection
Specimens will be collected using swab-based collection devices intended solely for specimen collection. These devices do not provide diagnostic results and are not used for clinical decision-making.
Time frame: Within 90 days of enrollment
Characterization of endometrial neoplasia, other neoplasms, or underlying causes
Characterization will be based on existing clinical assessments and diagnoses obtained through standard medical care. The study does not establish diagnostic criteria or endpoints and is intended for research and development purposes only.
Time frame: Within 90 days of enrollment
Plan to share: Yes — Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and the clinical study report (when applicable) will also be shared.
Supporting information: Study protocol, Informed consent form
Time frame: Data will be available from 2 years and ending 4 years after publication.
Access criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/IEC approvals or waivers as applicable to conduct research
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Apr 2028, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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