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.
Conditions:
🦠 Women's Health
🗓️ Study Start (Actual) 27 February 2024
🗓️ Primary Completion (Estimated) 1 November 2024
✅ Study Completion (Estimated) 29 November 2024
👥 Enrollment (Estimated) 270
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 June 2024
  • First Submitted that Met QC Criteria 13 June 2024
  • First Posted 14 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 June 2024
  • Last Update Posted 21 June 2024
  • Last Verified June 2024