Surgical Sample Collection- Sampling During Uterine Surgery

NCT06460818 | Completed

• 1 other identifier: PNK001
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Women's Health

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

benign

tissue collection from women with benign reproductive conditions

malignant

tissue collection from women with suspected and malignant reproductive conditions

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing hysterectomy.

You may qualify if:

• 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.
• Willing and able to comply with scheduled visits, investigational plan, and other procedures.
• Females:
• Aged \>45 for benign and pre-malignant cases
• Aged \>18 with positive biopsies.
• Presence of uterus.
• Scheduled for hysterectomy.

You may not qualify if:

• 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.
• Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.
• Women who have undergone a hysterectomy.
• Inability or unwillingness to sign informed consent.
• Contraindication to surgery, including pregnancy.
• Women who have used a tampon within 7 days of surgery.

Sponsors & Collaborators

• PinkDx, Inc.: lead

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

fresh and frozen tissue

Study Officials

• Andrea Mariani, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: February 27, 2024
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)