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Immunological profile of women with HPV in comparison to women without HPV

Immunological profile of women having HPV associated cervico-vaginal intraepithelial lesions and cancers in comparison to HPV negative women with or without cervico-vaginal pathology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/03/032288
Enrollment
128
Registered
2021-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: C530- Malignant neoplasm of endocervix

Interventions

None listed

Sponsors

Manipal Academy of higher education
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for the phase-1 study: All physically and mentally competent sexually exposed married women with cervico-vaginal intraepithelial neoplasias (CIN) or histologically confirmed cervical squamous cell cancers and retro-positive women with or without cytological abnormalities and women attending routine check-ups will be enrolled. Inclusion criteria for the phase-2 study: Age group between 18 to 45 years who can complete the questionnaires in English or Kannada.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the phase-1 study: Pregnant women, Women below 30 years, and women above 65 years of age, except those with diagnosed cancer cervix, where irrespective of age, women will be included, Women with auto-immune diseases, Women who previously received immunosuppressive treatment, radiotherapy, or chemotherapy, Women with a history of taking anti-inflammatory drugs within two weeks before sampling, Women who are actively taking oral contraceptives. Exclusion criteria for the phase-2 study: Pregnant women, women with history of hysterectomy

Design outcomes

Primary

MeasureTime frame
Our study will give information about immunological profile of genital HPV infected immunocompetent women and women having concurrent HIV infection Timepoint: 3 years

Secondary

MeasureTime frame
This study is expected to provide a sound rationale for decision making with respect to vaccination.Timepoint: 2

Countries

India

Contacts

Public ContactDr Revathi P Shenoy

Manipal academy of higher education

revathi.shenoy@manipal.edu9449367734

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026