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

NCT02622997 | Completed

• 1 other identifier: 10575
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

HPV self-sampling

Outcome Measures

Primary Outcomes (3)

• Presence of Human DNA measured by a qPCR assay and the quantity remaining under different storage conditions using dry flocked swabs and HerSwab

  From sample taken at baseline visit

• Presence of HPV DNA (primarily HPV16) measured by qPCR and the quantity remaining under different storage conditions using dry flocked swabs and HerSwab

  From sample taken at baseline visit

• RLUs or ct values measured using a validated HPV test on samples under different storage conditions using dry flocked swabs and HerSwab

  From sample taken at baseline visit

Secondary Outcomes (3)

• Primary endpoint 1 analysed by grade of histologically confirmed cervical intraepithelial neoplasia (CIN) or cytology

  Up to six months from baseline visit

• Primary endpoint 2 analysed by grade of histologically confirmed CIN or cytology

  Up to six months from baseline visit

• Primary endpoint 3 analysed by grade of histologically confirmed CIN or cytology

  Up to six months from baseline visit

Study Arms (1)

Flocked swab 1

EXPERIMENTAL

Cervico-vaginal self-sample taken with first flocked swab followed by cervico-vaginal self-sample taken with a second flocked swab and finally cervico-vaginal self-sample taken with a HerSwab device

Other: Cervico-vaginal self-sample taken with first flocked swab; Other: Cervico-vaginal self-sample taken with a second flocked swab; Other: Cervico-vaginal self-sample taken with a HerSwab device

Interventions

Cervico-vaginal self-sample taken with first flocked swab OTHER

Cervico-vaginal self-sample taken with first flocked swab

Flocked swab 1

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

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

Flocked swab 1

Cervico-vaginal self-sample taken with a HerSwab device OTHER

Cervico-vaginal self-sample taken with a HerSwab device

Flocked swab 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women attending for colposcopic examination at the Royal London Bart's Health Colposcopy Clinic
• Referred as a consequence of abnormal screening cytology
• Who have a cervix
• Who give written informed consent
• Aged 18 years and above

You may not qualify if:

• Pregnant at time of visit
• History of excisional or ablative treatment for CIN within the last three years

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Officials

• Mangesh A Thorat, MBBS

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will take two cervico-vaginal self-samples using flocked swabs and then a further cervicao-vaginal self-sample using a HerSwab collection device.

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: December 7, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 15, 2023

Record last verified: 2016-01