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Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine

NCT06261892 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-02-15

No results posted yet for this study

Summary

The goal of this clinical trial is

1. To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.
2. If HPV DNA is not a promising biomarker, other biomarkers will be explored.
3. To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.

The main question it aims to answer is:

To validate whether HPV DNA from urine could be used as a non-invasive means for the detection of pre-cervical or cervical cancer

Participants will

1. Join the briefing session of the study
2. Sign the consent form and health questionnaire
3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test
4. Collect the urine sample

If there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if HPV DNA from urine is a promising biomarker for the detection of pre-cervical or cervical cancer

Conditions

Interventions

DIAGNOSTIC_TEST

Collect HPV DNA from urine

Use a sample collector to collect urine

Sponsors & Collaborators

  • Hong Kong Science and Technology Parks Corporation

    collaborator UNKNOWN

  • WomenX Biotech Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261892 on ClinicalTrials.gov