NCT06527157 Investigations of Reproductive Cancers in Women
| NCT ID | NCT06527157 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PinkDx, Inc. |
| Condition | Uterine Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,500 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,500 participants in total. It began in 2024-07-30 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Andrea Mariani, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06527157 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 100 Years, studying Uterine Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06527157 currently recruiting?
Yes, NCT06527157 is actively recruiting participants. Contact the research team at devon@pinkdx.com for enrollment information.
Where is the NCT06527157 trial being conducted?
This trial is being conducted at Birmingham, United States, San Carlos, United States, Orlando, United States, Lake Forest, United States and 11 additional locations.
Who is sponsoring the NCT06527157 clinical trial?
NCT06527157 is sponsored by PinkDx, Inc.. The principal investigator is Andrea Mariani, MD at Mayo Clinic. The trial plans to enroll 4,500 participants.
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