NCT06460818

Completed

Surgical Sample Collection- Sampling During Uterine Surgery

PinkDx, Inc.Source

Other study identifiers

Sponsor study identifier

PNK001

Study Type

observational

Actual enrollment (reported)

234

Locations

1 country

Sites

3

Timeline

Study Start

February 27, 2024

Actual (reported)

Primary Completion

November 29, 2024

Actual (reported)

Study Completion

November 29, 2024

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 234 participants
Study completion date: November 29, 2024
Actual (reported)
Listed locations: 1 countries · 3 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 27, 2024
Actual (reported)
First Submitted
June 4, 2024
Actual (reported)
First Posted
June 14, 2024
Actual (reported)
Primary Completion
November 29, 2024
Actual (reported)
Study Completion
November 29, 2024
Actual (reported)

Last Updated: December 2, 2024
Status Verified: November 2024
Last Update Submitted: November 29, 2024

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

Age18 Years - 99 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

PinkDx, Inc.
Industrylead

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Columbia University

New York, New York, 10032, United States

Houston Methodist

Houston, Texas, 77030, United States

Biospecimen

Retention: SAMPLES WITH DNA

fresh and frozen tissue

Study Officials

Andrea Mariani, MD
Mayo Clinic
PRINCIPAL INVESTIGATOR

Enrollment

234 participants (actual enrollment reported by the registry).

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

Actual (reported)

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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.

Contact the study team to confirm eligibility.

Primary Completion

November 29, 2024

Actual (reported)

Study Completion

November 29, 2024

Actual (reported)

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06460818
Data provider: ClinicalTrials.gov
Source updated: 2024-12-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:37 UTC

Locations

US(3)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

benign

malignant

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations