Transmission of Oncogenic HPV Infection Among Families

NCT07036211 | Not Yet Recruiting

• 1 other identifier: R23092
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Oropharyngeal cancer; Cervical cancer; HPV

Outcome Measures

Primary Outcomes (1)

• HPV genotype among patients with HPV associated disease and their sexual couples

  All oral and genital samples are genotypes using extended HPV genotyping assays that detect at least 25 different HPV genotypes separately.

  From enrollment to 24 month follow-up samples

Study Arms (3)

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).

Offspring of patients with HPV associated disease

Children over 12 years old

Sexual partner (spouse) of patients with HPV associated disease

Women or men

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will be attending either the ObGyn or ENT at Tampere University Hospital (TAUH) or at Kuopio University Hospital (KUH) concerning HPV associated decease and their spouses and offspring.

You may qualify if:

• 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

You may not qualify if:

• Candidate who don't speak Finnish

Sponsors & Collaborators

• Tampere University Hospital: lead
• Kuopio University Hospital: collaborator

Study Sites (2)

Kuopio University Hospital

Kuopio, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will take swab/brush samples from the oral cavity, and cervix/vagina/anus (women), additionally urine (men) as well as saliva samples and gargle samples from oral cavity from all participating. The follow-up samples are self-collected samples: saliva, oral gargle, genital/urine sample. From the offspring the oral gargle and saliva is collected at each follow-up visit with optional vagina and urine sample.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Oropharyngeal Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karolina Louvanto, Professor

  Tampere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Louvanto, Professor

CONTACT

+35850 4713838; karolina.louvanto@pirha.fi

Eerika Karinen, Licentiate of Medicine

CONTACT

eerika.karinen@tuni.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: June 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months after publication with no end date
• Access Criteria: IPD that underlie the results reported in a publication, after de-identification, will be available for researchers who provide a methodologically sound proposal with achievable aims. Proposals should be directed via e-mail to the PI of the study (KL); data requestors will need to sign a data access agreement.

Locations

FI (2)