NCT06527157

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jul 2024Nov 2026

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

July 25, 2024

Last Update Submit

April 3, 2026

Conditions

Uterine Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    ability to detect cancer

    12 months

Secondary Outcomes (1)

  • Specificity

    12 months

Study Arms (2)

Benign

sample collection from females with benign causes of AUB/PMB

Malignant

sample collection from females with malignant causes of AUB/PMB

Eligibility Criteria

Age45 Years - 100 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females 45 years and older seeking medical attention for abnormal uterine or postmenopausal bleeding.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Sutter Health

Redwood City, California, 94062, United States

RECRUITING

Advent Health Orlando

Orlando, Florida, 32803, United States

RECRUITING

Ob-Gyne Associates of Lake Forest, Ltd

Lake Forest, Illinois, 60045, United States

ACTIVE NOT RECRUITING

Indiana University, Eskenazi Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

Summa Health

Akron, Ohio, 44304, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Avera Research Institute

Sioux Falls, South Dakota, 57108, United States

RECRUITING

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

RECRUITING

Meharry Medical College

Nashville, Tennessee, 37208, United States

RECRUITING

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Swab samples with DNA

MeSH Terms

Conditions

Uterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Andrea Mariani, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

VP, Clinical Operations

CONTACT

463-273-7024devon@pinkdx.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

July 30, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(16)