Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
700 participants
OBSERVATIONAL
2025-08-31
2031-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with HPV associated disease
1\) colposcopy clinic detected persisting HR-HPV infection, 2) diagnosed cervical cancer; or 3) diagnosed Oral squamous cell carcinoma (OSCC).
No interventions assigned to this group
Offspring of patients with HPV associated disease
Children over 12 years old
No interventions assigned to this group
Sexual partner (spouse) of patients with HPV associated disease
Women or men
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
100 Years
ALL
Yes
Sponsors
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Kuopio University Hospital
OTHER
Tampere University Hospital
OTHER
Responsible Party
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Principal Investigators
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Karolina Louvanto, Professor
Role: PRINCIPAL_INVESTIGATOR
Tampere University
Locations
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Kuopio University Hospital
Kuopio, , Finland
Tampere University Hospital
Tampere, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R23092
Identifier Type: -
Identifier Source: org_study_id
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