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Surgical Sample Collection- Sampling During Uterine Surgery

NCT ID: NCT06460818

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-27

Study Completion Date

2024-11-29

Brief Summary

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

Detailed Description

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Conditions

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Women's Health

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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benign

tissue collection from women with benign reproductive conditions

No interventions assigned to this group

malignant

tissue collection from women with suspected and malignant reproductive conditions

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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PinkDx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Mariani, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Houston Methodist

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PNK001

Identifier Type: -

Identifier Source: org_study_id