Diagnostic test to Investigate reproductive cancers in women
Lay Description
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
- Cancers and Other Neoplasms
- Reproductive Health
- Womens Health
- Female Reproductive System Neoplasm
- IRB Number
- STUDY00001628
- NCT Number
- NCT06527157
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
Study Contact
Sally Kabro
210-567-3742
kabro@uthscsa.edu
Krystin Cunningham
210-567-3941
cunninghamk3@uthscsa.edu
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