Uterine CancerPROACTION:NCT06527157
Investigations of Reproductive Cancers in Women
An observational study of Uterine Cancer, run by PinkDx, Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 100 years, women only
- Conditions the study is for
- Uterine Cancer
- How many people
- 4,500 participants
- Where
- 16 sitesUnited States
- Study dates
- 30 Jul 2024to 15 Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- Women only
- Adult, Older adult
Study population: Females 45 years and older seeking medical attention for abnormal uterine or postmenopausal bleeding.
Who may be able to join
- 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
Who cannot join
- 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.
- Women who have received prior treatment for endometrial cancer.
- Inability or unwillingness to sign informed consent.
- Clinical suspicion of pregnancy.
- Women who have used a tampon within 7 days of sample collection.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 13 recruiting
- Recruiting
Summa Health
Akron, Ohio, 44304
Sarah Stanaszeks, 330-375-9753, stanaszeks@summahealth.org
Clarissa Polen-De, MD
- Recruiting
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Stephanie Clevenger, 205-934-0877, slangan@uabmc.edu
Janeen Arbuckle, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Cindy Overholts, 614-293-4365, cindy.overholts@osumc.edu
Anne-Marie Sinay, MD
- Recruiting
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Jennifer DeVolder, R.N., 832-822-7406, Jennifer.DeVolder@bcm.edu
Nishath Ali, M.D.
- Recruiting
Houston Methodist
Houston, Texas, 77030
Jaya Kamath, MS, 713-441-6616, jskamath@houstonmethodist.org
Pedro Ramirez, MD
- Recruiting
Indiana University, Eskenazi Health
Indianapolis, Indiana, 46202
Shelley Dowden, 317-880-3954, sburn@iu.edu
David M. Haas, MD
- Active, not recruiting
Ob-Gyne Associates of Lake Forest, Ltd
Lake Forest, Illinois, 60045
- Recruiting
University of Tennessee Health Science Center
Memphis, Tennessee, 38103
Annette Hickerson, abpayne@uthsc.edu
Alexa Swailes, MD
- Recruiting
Meharry Medical College
Nashville, Tennessee, 37208
Melissa Allison, MPH RN, 615-327-3108, melissa.allison@mmc.edu
- Recruiting
Columbia University
New York, New York, 10032
Reena Vattakalam, 212-305-3410, rmv2110@cumc.columbia.edu
Jason D Wright, MD
- Recruiting
Advent Health Orlando
Orlando, Florida, 32803
Jenni Freed, RN, jenni.freed@adventhealth.com
Erica Stockwell, DO
- Active, not recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Krystin Cunningham, RN, 210-450-8817, cunninghamk3@uthscsa.edu
Sally Kabro, M.Sc., 708-560-1402, kabro@uthscsa.edu
- Recruiting
Sutter Health
San Carlos, California, 94070
Kristina Teresinski, CPT, 279-800-9026, Kristina.Teresinski@sutterhealth.org
John Hoff, MD, PhD
- Active, not recruiting
Avera Research Institute
Sioux Falls, South Dakota, 57108
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
Megan Dorsey, MPH, 314-273-2561, m.dorsey@wustl.edu
David Mutch, MD
About this study
Official title: PROspective ACcrual To Investigate reprOductive Cancers in womeN
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
- Uterine Cancer
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign | sample collection from females with benign causes of AUB/PMB | |
| Malignant | sample collection from females with malignant causes of AUB/PMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
ability to detect cancer
Measured: 12 months
Secondary outcomes (1)
Specificity
ability to identify benign cases
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start30 Jul 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion15 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PinkDx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Mariani, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527157
- Sponsor's protocol ID
- PNK002
- Acronym
- PROACTION:
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective ACcrual To Investigate reprOductive Cancers in womeN
- ClinicalTrials.gov ID
- NCT06527157
- Acronym / sponsor ID
- PROACTION: / PNK002
- Conditions
- Uterine Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- PinkDx, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 15 Nov 2031 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign | – | –sample collection from females with benign causes of AUB/PMB |
| Malignant | – | –sample collection from females with malignant causes of AUB/PMB |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Females 45 years and older seeking medical attention for abnormal uterine or postmenopausal bleeding.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Women who have received prior treatment for endometrial cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity
Time frame: 12 months
ability to detect cancer
1 secondary outcome
Specificity
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Mariani, MD principal investigator
Mayo Clinic
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cancer, run by PinkDx, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP, Clinical Operations (463-273-7024, devon@pinkdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.