Transmission of Oncogenic HPV Infection Among Families
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- HPV genotype among patients with HPV associated disease and their sexual couples
研究概览
简要总结
The goal of the Transmission of Oncogenic HPV Infection Among Families (TREVINO) study is to improve understanding of how high-risk human papillomavirus (HPV) infections are transmitted within families. The research focuses on transmission between sexual partners and between parents and children. It also examines how the various microbes may influence the persistence of HPV infections and the development of HPV-related cancers.
The study will include up to 300 couples recruited from gynecology and ear, nose, and throat (ENT) clinics in Finland, as well as their children. Participants include individuals with persistent HPV infection, cervical precancer or cancer, or HPV-related head and neck cancer, along with their partners and potentially their offspring.
Participants will provide self-collected samples from the oral and genital areas at multiple time points over up to five years. Questionnaires addressing medical, behavioural, and environmental factors will be completed.
The study is conducted at Tampere University Hospital and Kuopio University Hospital in Finland. Results will inform HPV screening and prevention programs, improve understanding of family-level transmission, and identify potential microbial and genetic markers linked to cancer risk.
详细描述
TREVINO (Transmission of Oncogenic HPV Infection Among Families) is a prospective and longitudinal research project aimed at investigating the transmission, persistence, and clinical consequences of high-risk human papillomavirus (HPV) infections within family. The study also explores how various microbes, as well as genetic and environmental factors, influence HPV infection outcomes.
The study consists of three main parts:
Part 1 focuses on assessing the prevalence, concordance and transmission of HPV infections among individuals with HPV-associated precancerous or cancerous lesions and their sexual partners (spouses).
Part 2 aims to characterize the role of the microbes in HPV persistence and the progression to cervical and oropharyngeal cancer.
Part 3 investigates vertical and horizontal transmission of HPV and microbial communities within families by including offspring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with colposcopy clinic detected persisting HR-HPV infection
- •Patient with diagnosed cervical cancer
- •Patient with diagnosed OSCC
- •Patients' sexual partners of women or men that are referred to the colposcopy/gynecological oncology/ENT
- •offspring (over 12 years old) of the referred couples
排除标准
- •Candidate who don't speak Finnish
结局指标
主要结局
HPV genotype among patients with HPV associated disease and their sexual couples
时间窗: From enrollment to 24 month follow-up samples
All oral and genital samples are genotypes using extended HPV genotyping assays that detect at least 25 different HPV genotypes separately.
次要结局
未报告次要终点