Transmission of Oncogenic HPV Infection Among Families

Not yet recruiting

• Conditions: Human Papilloma Virus (HPV); Cervical Carcinoma; Oropharyngeal Carcinoma; Transmission Vertical; Transmission; Human Papillomavirus Infection

• Registration Number: NCT07036211
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

Detailed Description

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.

Participants will include up to 300 couples recruited from Tampere University Hospital and Kuopio University Hospital in Finland, as well as their children. Recruitment targets women or men attending gynecology or ENT clinics with confirmed persistent HPV infection, cervical precancer or cancer, or oropharyngeal squamous cell carcinoma (OSCC). Partners are invited to participate regardless of symptom status.

Samples will be collected from patients with HPV associated decease at baseline, and then at 6, 12, and 24 months, with extended follow-up to 60 months for individuals with persistent infections. Self-sampling kits for oral, genital, urine, saliva, and gargle samples will be distributed and returned via mail. Partners will give samples at 0, 12 and 24 months and will have the extended follow-up for individuals with persistent infections. Children will provide oral samples, and optional urine or vaginal samples at 0, 12 and 24 months. Offspring over 30 years old will also have the opportunity to participate the extended follow-up.

Biological assays include HPV genotyping, HLA typing, immunohistochemistry, in situ hybridization, metagenomic sequencing, methylation analysis, and targeted sequencing.

Statistical analysis plans will vary by study objective and will include logistic regression, generalized estimating equations (GEE), ROC curve construction, and compositional methods for microbial profiling. All analyses will be conducted using Stata.

The study has been approved by the Pirkanmaa County Ethical Review Board. Recruitment is expected to begin in spring 2025. Findings will support the development of prevention strategies, improved risk stratification, and innovative diagnostic and therapeutic approaches for HPV-associated diseases.

Study Timeline

• Study First Submitted: 2025-04-23
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-08-01
• Primary Completion: 2027-05
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• 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

Exclusion Criteria

• Candidate who don't speak Finnish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV genotype among patients with HPV associated disease and their sexual couples	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.

Trial Locations

Locations (2)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland