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Accuracy of mRNA EXPRESSION OF SERPIN B3 AND LRG1 IN detecting premalignant lesions of the cervix.

SENSITIVITY AND SPECIFICITY OF mRNA EXPRESSION OF SERPIN B3 AND LRG1 IN PREDICTING CERVICAL PREMALIGNANT LESIONS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029690
Enrollment
222
Registered
2020-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: N72- Inflammatory disease of cervix uteri

Interventions

None listed

Sponsors

Manipal College of Health Professions
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For healthy controls: 1 Negative for intraepithelial lesion For premalignant lesions: 1 Women above 25 to 65 years attending the department of OBG at Kasturba Hospital, Manipal undergoing Pap smear testing 2 Epithelial cell abnormality ââ?¬â?? Squamous cells which include ASC-US Squamous cells (Atypical squamous cells of uncertain significance), ASC-H (Atypical squamous cells ââ?¬â?? HSIL cannot be excluded), LSIL (Low grade squamous intraepithelial lesion), HSIL (High grade squamous intraepithelial lesion) - Moderate dysplasia (CIN-II), Severe dysplasia (CIN- III) For malignant lesions: 1 Women with clinically diagnosed carcinoma of cervix attending Radiotherapy and Oncology department.

Exclusion criteria

Exclusion criteria: For healthy controls: � NILM without any infection or reactive changes For premalignant lesions � Heavy discharge and infections � Menstruation � History of CC � Atypical Glandular cells on Pap test

Design outcomes

Primary

MeasureTime frame
Performance of Serpin B3 and LRG1 mRNA expression for the early prediction of cervical malignant lesionTimepoint: At baseline

Secondary

MeasureTime frame
- Association of HPV DNA (16 and 18) with alteration in microbiota of cervix - Reliability of automated pap smear reports with predictive values Timepoint: 4 years

Countries

India

Contacts

Public ContactReshma Maria Cocess Dsouza

Manipal College of Health Profssions

reshma.dsouza@manipal.edu08147804182

Outcome results

None listed

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