A study to assess whether urine and vaginal samples collected by the women themselves can be used for screening for cervical cancer by testing them with the Xpert HPV assay, which provides results in a very short time

Clinical and Analytical Performance of Urine and Self-collected Vaginal Samples by Point-of-care Xpert HPV Assay on GeneXpert Platform for Detecting HPV and CIN2-plus Lesions - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112271

Enrollment

110

Registered

2026-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N871- Moderate cervical dysplasia

Interventions

Intervention1: Urine and vaginal self samples for testing for HR-HPV DNA by Xpert assay: Women recruited to the study will provide urina samples and vaginal self-samples for testing for HR-HPV DNA by

Eligibility

Inclusion criteria

Inclusion criteria: Women with HSIL on cervical cytology, Age between 30-60 years, Willing to participate.

Exclusion criteria

Exclusion criteria: Pregnancy Less than 6 weeks postpartum HPV vaccinated

Design outcomes

Primary

Measure	Time frame
Primary outcomes: Analytical performance point-of-care HPV Xpert Assay on self-collected urine and vaginal samples as compared GeneXpert assay on physician-collected cervical samples in detecting hr-HPV DNA. The clinical performance of point-of-care HPV Xpert Assay on self-collected urine and vaginal samples in terms of concordance with cervical cytology and detection of CIN2 and above lesion. Secondary outcome: Acceptance and preference of various sampling methods by women. Timepoint: Preparation and procurement over 3 months (completed) Recruitment and study procedures and data entry and data management simultneously over 18 months Data analysis and report writing over 3 months	—

Measure

Time frame

Primary outcomes: Analytical performance point-of-care HPV Xpert Assay on self-collected urine and vaginal samples as compared GeneXpert assay on physician-collected cervical samples in detecting hr-HPV DNA. The clinical performance of point-of-care HPV Xpert Assay on self-collected urine and vaginal samples in terms of concordance with cervical cytology and detection of CIN2 and above lesion. Secondary outcome: Acceptance and preference of various sampling methods by women. Timepoint: Preparation and procurement over 3 months (completed) Recruitment and study procedures and data entry and data management simultneously over 18 months Data analysis and report writing over 3 months

—

Secondary

Measure	Time frame
Acceptance and preference of various sampling methods by women.Timepoint: The procedures for the secondary objective will be carried out simultaneously	—

Countries

India

Contacts

Public ContactRimpi Singla

Post Graduate Institute of Medical Education and Research, Chandigarh

drrimpisingla@gmail.com7087008008

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026