Surgical Sample Collection- Sampling During Uterine Surgery

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

Study Overview

• Status: Completed
• Conditions: Women's Health

• Study Type: Observational
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing hysterectomy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
benign; tissue collection from women with benign reproductive conditions
malignant; tissue collection from women with suspected and malignant reproductive conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with optimal vaginal samples obtained during the collection process	Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples.	9 months

Collaborators and Investigators

• Sponsor: PinkDx, Inc.
• Investigators: Principal Investigator: Andrea Mariani, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PNK001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No