Women's Health
Conditions
Brief summary
The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.
Interventions
None listed
Sponsors
PinkDx, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, investigational plan, and other procedures. 3. Females: 1. Aged \>45 for benign and pre-malignant cases 2. Aged \>18 with positive biopsies. 4. Presence of uterus. 5. Scheduled for hysterectomy.
Exclusion criteria
1. Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members. 2. Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator. 3. Women who have undergone a hysterectomy. 4. Inability or unwillingness to sign informed consent. 5. Contraindication to surgery, including pregnancy. 6. Women who have used a tampon within 7 days of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with optimal vaginal samples obtained during the collection process | 9 months | Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples. |
Countries
United States
Outcome results
None listed