RecruitingNot Applicable

Investigations of Reproductive Cancers in Women

United States4,500 participantsStarted 2024-07-30

Plain-language 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.

Who can participate

Age range

45 Years – 100 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
. Willing and able to comply with scheduled visits, study plan, and other procedures.
. Expected to be available for the duration of the study and can be contacted by telephone during study participation.
. Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).
. Presence of uterus.
. AUB or PMB being worked up to diagnose the cause of the bleeding

Exclusion criteria

. 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.
. Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
. Women who have had a hysterectomy.
. Women with a known history of endometrial cancer or uterine sarcoma.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity

Timeframe: 12 months

Trial details

NCT IDNCT06527157

SponsorPinkDx, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10-30

Contact for this trial

VP, Clinical Operations

463-273-7024 devon@pinkdx.com

View on ClinicalTrials.gov More Uterine Cancer trials