Human Papilloma Virus (HPV)TREVINONCT07036211
Transmission of Oncogenic HPV Infection Among Families
An observational study of Human Papilloma Virus (HPV) and Cervical Carcinoma, run by Tampere University Hospital at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus (HPV), Cervical Carcinoma, Oropharyngeal Carcinoma
- Type of treatment
- Pill or oral medicine
- How many people
- 700 participants
- Where
- 2 sitesFinland
- Study dates
- Aug 2025to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Candidate who don't speak Finnish
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eerika Karinen, Licentiate of Medicine contact
Finland2 sites
Kuopio University Hospital
Kuopio
Anna Jouppila-Mättö, Doctor of medical science, +35844 7172834, anna.jouppila-matto@pshyvinvointialue.fi
Teemu Taalamo, Licentiate of Medicine, teemu.taalamo@pshyvinvointialue.fi
Tampere University Hospital
Tampere
Karolina Louvanto, Professor, +35850 4713838, karolina.louvanto@pirha.fi
Eerika Karinen, Licentiate of Medicine, eerika.karinen@tuni.fi
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Human Papilloma Virus (HPV), Cervical Carcinoma, Oropharyngeal Carcinoma, Transmission Vertical, Transmission, Human Papillomavirus Infection
- Keywords
- Oropharyngeal cancer, Cervical cancer, HPV
- Medical subject headings
- Uterine Cervical Neoplasms, Oropharyngeal Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 24 month follow-up samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus (HPV)Studies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital
- Responsible party
- Sponsor
- Investigators
- Karolina Louvanto, Professor, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036211
- Sponsor's protocol ID
- R23092
- Acronym
- TREVINO
- Status last verified
- Jun 2025
- First submitted
- 23 Apr 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission of Oncogenic HPV Infection Among Families
- ClinicalTrials.gov ID
- NCT07036211
- Acronym / sponsor ID
- TREVINO / R23092
- Conditions
- Human Papilloma Virus (HPV), Cervical Carcinoma, Oropharyngeal Carcinoma, Transmission Vertical, Transmission, Human Papillomavirus Infection
- Keywords
- Oropharyngeal cancer, Cervical cancer, HPV
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Kuopio University Hospital
- Study start
- Aug 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Candidate who don't speak Finnish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HPV genotype among patients with HPV associated disease and their sexual couples
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eerika Karinen, Licentiate of Medicine contact
Karolina Louvanto, Professor principal investigator
Tampere University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus (HPV) and Cervical Carcinoma, run by Tampere University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karolina Louvanto, Professor (+35850 4713838, karolina.louvanto@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV genotype among patients with HPV associated disease and their sexual couples (time frame: From enrollment to 24 month follow-up samples). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.