Clinical trial NCT06527157: Investigations of Reproductive Cancers in Women
Official title: PROspective ACcrual To Investigate reprOductive Cancers in womeN
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Cancer
Lead sponsor: PinkDx, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 4500
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females 45 years and older seeking medical attention for abnormal uterine or postmenopausal bleeding.

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.

Primary outcomes:
measure: Sensitivity
timeFrame: 12 months
Secondary outcomes:
measure: Specificity
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Redwood City
country: United States
facility: Sutter Health
state: California
city: Lake Forest
country: United States
facility: Ob-Gyne Associates of Lake Forest, Ltd
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Columbia University
state: New York
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Andrea Mariani, MD
role: PRINCIPAL_INVESTIGATOR
References: