Purpose

To develop a non-invasive test that can be collected in the office to rule out endometrial cancer early in the work-up and improve the patient journey.

Category

IRB Number
STUDY00001628
NCT Number
NCT06527157
Sponsor
-



Study Contact

Marisa Fernandez
210-450-8016
Fernandezm10@uthscsa.edu

Sally Kabro
708-560-1402
kabro@uthscsa.edu

Krystin Cunningham
210-450-8817
cunninghamk3@uthscsa.edu

Principal Investigator
Georgia McCann

Sally Kabro
210-567-3742
kabro@uthscsa.edu

Krystin Cunningham
210-567-3941
cunninghamk3@uthscsa.edu



Eligibility

Eligible Ages
45 - 100
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

    • Evidence of a personally signed and dated informed consent form (ICF) indicating that the subject has been informed of all pertinent aspects of the study.
    • Willing and able to comply with scheduled visits, investigational 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 (with roughly 80% of enrolled subjects over the age of 50).
    • Presence of uterus.
    • AUB or PMB being evaluated to rule out cancer.

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 acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgment of the Investigator.
    • Women who have undergone 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.

Study Design


Arm Groups