Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 45 Years and 100 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Benign sample collection from females with benign causes of AUB/PMB
Malignant sample collection from females with malignant causes of AUB/PMB

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Krystin Cunningham, RN
210-450-8817
cunninghamk3@uthscsa.edu

More Details

Status
Recruiting
Sponsor
PinkDx, Inc.

Study Contact

VP, Clinical Operations
463-273-7024
devon@pinkdx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.