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Predictors of CIN Study Series 5.0:Stability Study in Vaginal Self-samples

NCT02622997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-15

No results posted yet for this study

Summary

60 women from the Colposcopy Clinic at the Royal London Hospital will be recruited, having been referred following an abnormal cervical screening result.

Aim Human Papillomavirus (HPV) is very common and can cause cervical cancer in some women. There is interest in HPV testing in place of the smear test currently used for cervical screening. HPV testing has potential for women to take self-samples.

These self-samples have up to now mostly been placed into liquid to preserve them before testing. Using liquid however, makes it more difficult to collect samples at home due to spillage and the logistics of posting. Investigators plan to investigate whether dry samples are reliable. Investigators would also like to know if samples can still be used if not tested immediately, particularly in warm temperatures. This would prove useful in the countries that have found it difficult to set up national cervical screening programmes.

Trial Design Investigators are asking women to take three vaginal self-samples before patients' colposcopy examination. The samples will be two swabs and a third using the HerSwab device, designed to make taking a sample easier. Investigators will give women instruction sheets with illustrations. Samples, taken in a random order so that all samples have an equal chance, will be sent to the laboratory for testing but under different conditions. Samples will be either frozen immediately, stored at 25ºC for one week or two weeks and then frozen. All samples will then undergo HPV testing. Investigators wish to see if all conditions and swabs provide similar amounts of HPV.

Enrolment is planned to start in May 2015. Sample processing and testing will continue until enrolment is complete and for a further month. Smear and biopsy results will be collected for up to 6 months to see if they affect quantities of HPV.

Conditions

  • Human Papillomavirus

Interventions

OTHER

Cervico-vaginal self-sample taken with first flocked swab

Cervico-vaginal self-sample taken with first flocked swab

OTHER

Cervico-vaginal self-sample taken with a second flocked swab

Cervico-vaginal self-sample taken with a second flocked swab

OTHER

Cervico-vaginal self-sample taken with a HerSwab device

Cervico-vaginal self-sample taken with a HerSwab device

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Mangesh A Thorat, MBBS · Queen Mary University of London

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

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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 NCT02622997 on ClinicalTrials.gov