Uterine Cancer
Conditions
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.
Interventions
None listed
Sponsors
PinkDx, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 12 months | ability to detect cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | 12 months | ability to identify benign cases |
Countries
United States
Contacts
CONTACTVP, Clinical Operations
PRINCIPAL_INVESTIGATORAndrea Mariani, MD
Mayo Clinic
Outcome results
None listed