NCT06528184

Brief Summary

Primary objective of the study is to determine the extent that offering of self-sampling in addition to clinician-sampling Human Papillomavirus (HPV) DNA testing will increase detection of HPV DNA through an increase in uptake rates of cervical cancer screening as compared to offering clinician-sampling HPV DNA testing alone. The hypothesis is that offering additional self-sampling will increase the detection of high-risk HPV DNA by at least 7.7%.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Aug 2024

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 Progress76%
Aug 2024Dec 2026

First Submitted

Initial submission to the registry

July 3, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

August 5, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 10, 2025

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

July 3, 2024

Last Update Submit

February 5, 2025

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Detection of high-risk Human Papillomavirus (HPV) DNA

    Difference in detection of high-risk HPV DNA between 2 arms

    3 months

Secondary Outcomes (8)

  • Uptake of cervical cancer screening

    3 months

  • Colposcopy referrals

    2 years

  • Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers

    2 years

  • Treatments for CIN 2, CIN 3 and cervical cancers

    2 years

  • Cost-effectiveness of cervical cancer screening

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Usual care arm

ACTIVE COMPARATOR

Participants will only be offered clinician-sampling for HPV DNA testing to determine if they are agreeable to undergo screening.

Diagnostic Test: Clinician-sampled HPV DNA test

Intervention arm

EXPERIMENTAL

Participants will be offered clinician-sampling or self-sampling for HPV DNA testing to determine if they are agreeable to undergo screening using either modality.

Diagnostic Test: Self-sampled HPV DNA testingDiagnostic Test: Clinician-sampled HPV DNA test

Interventions

Self-sampled HPV DNA testingDIAGNOSTIC_TEST

Participants will be offered HPV DNA testing done through self-sampling (using self-sampling HPV DNA kits to obtain a mid-vaginal swab)

Intervention arm
Clinician-sampled HPV DNA testDIAGNOSTIC_TEST

Participants will be offered HPV DNA testing through clinician sampling (clinician-sampling (speculum examination by a nurse to obtain a cervical swab)

Intervention armUsual care arm

Eligibility Criteria

Age30 Years - 69 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old female Singapore citizens
  • Due for cervical cancer screening
  • Engaged in sexual intercourse before
  • Able to give informed consent
  • Able to read and communicate in English, Chinese or Malay

You may not qualify if:

  • Virgo intacta
  • Pregnancy
  • History of cervical cancer, precancerous cervical lesions and total hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Healthcare Group Polyclinics

Singapore, Singapore, 138543, Singapore

RECRUITING

Related Publications (1)

  • Ng XR, Quek IP, Pereira MJ, Molina JA, Ngeow J, Wong SKW. Randomised controlled trial evaluating the impact of different methods of HPV DNA testing for cervical cancer screening in Singapore's primary care settings: a study protocol. BMJ Open. 2025 Mar 24;15(3):e095091. doi: 10.1136/bmjopen-2024-095091.

    PMID: 40132819DERIVED

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 Officials

  • Ng Xin Rong, MBBS

    National Healthcare Group Polyclinics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ng Xin Rong, MBBS

CONTACT

+65 63553000xin_rong_ng@nhgp.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Family Physician

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 30, 2024

Study Start

August 5, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 10, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)