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Clinical Trials/ISRCTN13476702
ISRCTN13476702
Completed
未知

Prospective cohort study to evaluate point-of-care HPV-DNA testing for the early detection and treatment of cervical pre-cancer in high-burden, low-resource settings

Kirby Institute UNSW Sydney0 sites4,285 target enrollmentSeptember 25, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Cervical pre-cancer and cervical cancer
Sponsor
Kirby Institute UNSW Sydney
Enrollment
4285
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35878625/ (added 26/07/2022)

Registry
who.int
Start Date
September 25, 2018
End Date
March 30, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Kirby Institute UNSW Sydney

Eligibility Criteria

Inclusion Criteria

  • 1\. Aged 30\-59 years
  • 2\. Attending a participating Well Woman Clinic
  • 3\. Willing to provide self\-collected vaginal swabs for baseline Xpert HPV testing
  • 4\. Willing to comply with study follow\-up procedures
  • 5\. Willing to undergo a clinical interview and pelvic examination
  • 6\. Willing to provide self\-collected and clinician\-collected specimens for laboratory investigations
  • 7\. Able to complete study informed consent procedures, to understand why the study is being carried out, and the potential risks and benefits associated with study participation;
  • 8\. Able to provide reliable contact details to facilitate future community tracing and follow\-up

Exclusion Criteria

  • 1\. Currently pregnant or given birth in the last 6 weeks
  • 2\. Previous diagnosis of cervical cancer and/or has had a hysterectomy
  • 3\. Permanent disability, that prevents or impedes study participation and/or comprehension (such that it is not possible to obtain informed consent to participate)
  • 4\. Women having their menstrual period at the time of the clinic visit will be advised to return for screening in 1\-2 weeks

Outcomes

Primary Outcomes

Not specified

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