Surgical Sample Collection- Sampling During Uterine Surgery

PinkDx, Inc.

Status: Completed

Conditions: Women's Health

Study type: Observational

Funder types: Industry

Identifiers

NCT06460818

PNK001

Details and patient eligibility

About

The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.

Enrollment: 234 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

234 participants in 2 patient groups

benign

Description:

tissue collection from women with benign reproductive conditions

malignant

Description:

tissue collection from women with suspected and malignant reproductive conditions