Clinical trial · Observational
Investigations of Reproductive Cancers in Women
PROspective ACcrual To Investigate reprOductive Cancers in womeN
NCT06527157CI-TRIAL-00122293PROACTION:recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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 goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.
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 |
|---|---|---|---|
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Benign
- description
- sample collection from females with benign causes of AUB/PMB
- label
- Malignant
- description
- sample collection from females with malignant causes of AUB/PMB
Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- 12 months
- description
- ability to detect cancer
Secondary outcomes (1)
- measure
- Specificity
- timeFrame
- 12 months
- description
- ability to identify benign cases
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, study plan, and other procedures. 3. Expected to be available for the duration of the study and can be contacted by telephone during study participation. 4. Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50). 5. Presence of uterus. 6. AUB or PMB being worked up to diagnose the cause of the bleeding Exclusion Criteria: 1. Investigator site staff members directly involved in the conduct of the study and their family members or subjects who are PinkDx, Inc. employees or their family members. 2. Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator. 3. Women who have had a hysterectomy. 4. Women with a known history of endometrial cancer or uterine sarcoma. 5. Women who have received prior treatment for endometrial cancer. 6. Inability or unwillingness to sign informed consent. 7. Clinical suspicion of pregnancy. 8. Women who have used a tampon within 7 days of sample collection.
References
Publications (0)
Data not yet available
No reference posted for this study.