None listed
Conditions
Sponsors
IOTA Diagnostic Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy women volunteers are chosen aged 30 to 55 years. 2. Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure. 3. Subjects who are compliant with the study
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women. 2. Clinical evidence of any serious systemic disease or acute illness, in the clinical opinion of the Investigator. 3. Subjects who are surgically sterile or have attained menopause (if they had their last menstruation more than 2 years back. 4. Subjects who were previously included or had participated in any other clinical study within 30 days prior to the date of consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of adequate samples for evaluation out of total samples collected. 2. Concordance between HPV positive samples in Menstrual blood collected using M StripTM versus conventional method.Timepoint: Day 1, Day 2 & Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Laboratory analysis and confirmation of the menstrual blood samples collected on the first three days of menstruation. 2. The prevalence of the different high risk HPV subtypes and the associated cyto-morphological status of the cervix.Timepoint: Day 1, Day 2 & Day 3 | — |
Countries
India
Contacts
Public ContactMeena Dalal
Sterling Hospital
Outcome results
None listed