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临床试验/CTRI/2026/02/104600
CTRI/2026/02/104600尚未招募不适用

HPV Detection in Urine and Cervical Swabs: A Comparative Analysis with Oncogenic Risk Assessment

Poornisha J1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2026年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
216
试验地点
1

研究概览

简要总结

Cervical cancer remains a major global public health concern, ranking as the fourth most common cancer among women worldwide, with an estimated 6,60,000 new cases and 3,50,000 deaths reported in 2022. The burden falls disproportionately on low- and middle-income countries. The Southeast Asia Region reports the second-highest incidence and mortality, with India contributing more than 65% of the regional burden. In India, cervical cancer is the second most common cancer among women, yet national screening coverage remains extremely low. Persistent infection with high-risk types of Human Papillomavirus (HPV), particularly types 16 and 18, is responsible for nearly 99% of cases. Although cervical cancer is largely preventable through vaccination and early detection, gaps in awareness, access, and acceptance continue to hinder effective prevention.

The World Health Organization (WHO) has introduced a global strategy to eliminate cervical cancer, setting the 90–70–90 targets to be reached by 2030.(1) However, several challenges continue to slow this progress, including inadequate access to screening services, limited awareness about HPV and its vaccination, and the hesitation many women feel toward invasive sample collection procedures. Against this backdrop, the proposed study assumes considerable importance. By examining HPV detection in both cervical swabs and urine samples, the study seeks to explore a screening alternative that is less invasive and potentially more acceptable to women, thereby supporting broader participation in screening initiatives. The inclusion of a questionnaire to evaluate knowledge, awareness, and attitudes related to HPV infection, HPV-related cancers, and HPV vaccination among women of reproductive age is expected to shed light on prevailing knowledge gap. Additionally, correlating Pap smear cytology findings with virological HPV test results will enhance the clinical significance of the research. Together, these components support the development of accessible, evidence-based screening strategies, directly contributing to WHO elimination goals and strengthening cervical cancer prevention efforts in the current public health trend.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Women who come for cervical screening in the reproductive age group and elderly (aged 21-65 years) White discharge per-vaginum Pain in the lower abdomen Intermenstrual bleeding Post-menopausal bleeding Dyspareunia Menstrual abnormalities.

排除标准

  • Women below 20 years of age Women who are pregnant Women who use local douche Women not willing to give consent for pap smear/ HPV testing.

研究者

发起方
Poornisha J
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

Poornisha J

Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)

研究点 (1)

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