Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: CERVICHECKââ??¢
Self-Sampling KIT: 1. Disposable Sample collection device with a cytobrush 2. Lubricant Gel 3. Sample Collection Media with Customer Identification Form 4. Resealable
Sponsors
Pragmatech Healthcare Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women with a positive cervical cancer screening test report (Pap, VIA or an HPV test done outside of the study) in the past one year but without any history of treatment for a cervical abnormality 2.All the women referred to colposcopy clinic in the age group from 25 to 60 years (25 and 60 years included) 3. Women ever exposed to sex/ married women. 4. Able to understand and sign voluntarily the consent to participate or willing to provide a thumb impression.
Exclusion criteria
Exclusion criteria: 1.Women who have been treated for cervical abnormalities and now have a normal screening test report 2.Women in the menstruating phase 3.Women who are pregnant 4.Women who have used vaginal medicines in the past 1 week 5.Previous history of hysterectomy 6.Previous history of cervical cancer 7.Negative LBC/HPV less than 3 years ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of self-sampled and clinician collected cervical cell sample for estimating Percent Positive agreement (PPA) in HPV assayed samplesTimepoint: At Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability and feasibility of self-sampling kit based on the participantsââ?¬â?¢ views from a questionnaire. ââ?¬Â¢The concordance for both HPV 16/18 and other high-risk HPV types separately in the self-sample and the clinician collected samples. ââ?¬Â¢Estimating concordance between LBC results for self- and clinician-sampled specimens using kappa statistic. Timepoint: At Baseline | — |
Countries
India
Contacts
Public ContactMr Anirban Palit
Pragmatech Healthcare Solutions Pvt.Ltd
Outcome results
None listed