Clinical trial · Observational
Detection of Endometrial Cancer Through Risk Modelling
Non-Invasive Strategies for Early Detection of Uterine Cancer in Patients With Abnormal Uterine Bleeding
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study goal is to investigate a non-invasive approach to predict endometrial cancer (EC) risk, better understand disease progression and identify opportunities for intervention. This two-part case-cohort prospective study will recruit patients whose abnormal uterine bleeding is being evaluated via endometrial biopsy. Participants will complete an online health questionnaire, and a subset will be invited to self-collect vaginal samples for sequencing. Selected sequenced participants will be invited for longitudinal monitoring (questionnaires, wearable fitness tracker) and an additional vaginal self-collection to identify persistent genetic mutations or microbiome alterations 6-8 months later.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- EIN/EC BIOPSY RESULT
- description
- Vaginal samples sequenced. Participation ends here.
- label
- EH BIOPSY RESULT
- description
- Vaginal samples sequenced. Subset invited to move on to longitudinal monitoring and samples sequenced for 6 additional months.
- label
- NEGATIVE BIOPSY RESULT
- description
- Control for natural and spontaneous changes in vaginal samples sequenced. Random subset selected to move on to longitudinal monitoring and samples sequenced for 6 additional months.
Primary outcomes (2)
- measure
- Diagnostic Performance of cfDNA Mutation Detection for Endometrial Pathology
- timeFrame
- Through study completion, anticipated 1-2 years
- description
- Cell-free DNA (cfDNA) extracted from vaginal swabs will be sequenced to identify endometrial cancer-associated mutations. Diagnostic performance will be evaluated by calculating sensitivity, specificity, accuracy, positive predictive value, and negative predictive value for detecting endometrial pathology, using biopsy-confirmed pathology as the reference standard.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: Study Part A: * 40 years and older * Experiencing unexplained abnormal uterine bleeding (i.e., not from IUD, etc.) * Have an intact uterus * Referred for an endometrial biopsy Study Part B/Longitudinal monitoring: * Those selected for sequencing (from Part A) and who retained their uterus. Exclusion Criteria: Study Part A: * Endometrial sampling, pelvic radiation, or vaginal infection (vaginosis, yeast) in the past 3 months * Started hormone therapy (HRT, birth control, IUD) in the past year (with the exception of tamoxifen) * Intercourse, vaginal product use, or douching in the past 48 hours Study Part B/Longitudinal monitoring: * Same as Study Part A * EC or EIN, or anyone who is recommended a hysterectomy
References
Publications (1)
- BACKGROUNDPfeiffer RM, Park Y, Kreimer AR, Lacey JV Jr, Pee D, Greenlee RT, Buys SS, Hollenbeck A, Rosner B, Gail MH, Hartge P. Risk prediction for breast, endometrial, and ovarian cancer in white women aged 50 y or older: derivation and validation from population-based cohort studies. PLoS Med. 2013;10(7):e1001492. doi: 10.1371/journal.pmed.1001492. Epub 2013 Jul 30. PMID 23935463