NCT06261892

Brief Summary

The goal of this clinical trial is

  1. 1.To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.
  2. 2.If HPV DNA is not a promising biomarker, other biomarkers will be explored.
  3. 3.To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.
  4. 4.Join the briefing session of the study
  5. 5.Sign the consent form and health questionnaire
  6. 6.Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test
  7. 7.Collect the urine sample

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

February 7, 2024

Last Update Submit

February 7, 2024

Conditions

Cervical Cancer

Keywords

pre-cervical cancercervical cancerCINSanitary padnon-invasive detection methodHPV

Outcome Measures

Primary Outcomes (1)

  • HPV DNA from urine is a promising biomarkers for the detection of pre-cervical/ cervical cancer

    Briefly, in order to concentrate all DNA, including cell free DNA fragments, gDNA extraction kit (Solarbio) will be used according to the manufacturer's instructions. Real time- polymerase chain reaction or multiple assays will be carried out using designed primers of HPV types. Primers for endogenous control are included to control DNA quality.

    From enrollment to sample analysis, 1month

Study Arms (1)

Collect HPV DNA from urine

EXPERIMENTAL
Diagnostic Test: Collect HPV DNA from urine

Interventions

Collect HPV DNA from urineDIAGNOSTIC_TEST

Use a sample collector to collect urine

Collect HPV DNA from urine

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female aged between 18 to 65
  • Have menstruation
  • Had sex before
  • Can read and write Chinese/ English
  • Without taking any medication (Except nutritional supplements, traditional Chinese medicine, and health care products etc.)

You may not qualify if:

  • Subjects who used medication will be excluded from the sample collection. Moreover, subjects with visible signs of gynarcological infections (e.g. gonorrhea, trichomonas vaginalis) or suffered an HIV/ hepatitis B virus (HBV)-infection will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WomenX Biotech Limited

Hong Kong, Hong Kong

RECRUITING

Related Publications (4)

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND

  • Teame H, Addissie A, Ayele W, Hirpa S, Gebremariam A, Gebreheat G, Jemal A. Factors associated with cervical precancerous lesions among women screened for cervical cancer in Addis Ababa, Ethiopia: A case control study. PLoS One. 2018 Jan 19;13(1):e0191506. doi: 10.1371/journal.pone.0191506. eCollection 2018.

    PMID: 29352278BACKGROUND

  • Aoki ES, Yin R, Li K, Bhatla N, Singhal S, Ocviyanti D, Saika K, Suh M, Kim M, Termrungruanglert W. National screening programs for cervical cancer in Asian countries. J Gynecol Oncol. 2020 May;31(3):e55. doi: 10.3802/jgo.2020.31.e55. Epub 2020 Feb 26.

    PMID: 32266804BACKGROUND

  • Wang B, He M, Chao A, Engelgau MM, Saraiya M, Wang L, Wang L. Cervical Cancer Screening Among Adult Women in China, 2010. Oncologist. 2015 Jun;20(6):627-34. doi: 10.1634/theoncologist.2014-0303. Epub 2015 May 8.

    PMID: 25956407BACKGROUND

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Founder, Principal Investigator, Director

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 15, 2024

Study Start

July 20, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)