Recurrent Respiratory PapillomatosisNCT06412172
The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)
An observational study of Recurrent Respiratory Papillomatosis and Pulmonary Neoplasm, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Recurrent respiratory papillomatosis (RRP) is an orphan disease that affects approximately 20,000 people in the United States and is caused by infection with human papillomavirus (HPV) types 6 and 11. Since RRP is an orphan disease, it is an understudied disease entity with correspondingly few treatment options. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Recurrent Respiratory Papillomatosis, Pulmonary Neoplasm
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 15 Apr 2030
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with HPV-associated RRP. The investigators will collect, store, and study primary tissue and distant anatomic sites of disease which were removed as part of standard of care.
Who may be able to join
- History of HPV-associated Recurrent Respiratory Papillomatosis
- Has pulmonary lesions
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marcelle Stiff contact
United States1 site, 1 recruiting
- Recruiting
Yale School of Medicine
New Haven, Connecticut, 06520
Sara Pai, MD, PhD
About this study
Recurrent respiratory papillomatosis (RRP) is an orphan disease that affects approximately 20,000 people in the United States and is caused by infection with human papillomavirus (HPV) types 6 and 11. Since RRP is an orphan disease, it is an understudied disease entity with correspondingly few treatment options. The investigators hypothesize that by understanding the biology of RRP and the failed host immune responses against HPV, novel and rational therapies can be developed. This study will examine the genetic and immunologic alterations found in these rare tumors and distant metastatic involved sites (such as the lung) in patients diagnosed with RRP.
Read the detailed description
Since RRP is an orphan disease, any single institution or hospital treats a limited number of RRP patients. The primary purpose for establishing a tissue repository is to collect RRP tissue from various institutions and hospitals and to provide investigators access to a large number of RRP tissues to perform genetic and immunologic studies of these rare tumors. This is both a prospective and retrospective tissue collection repository. Tissue that will be collected will include excess fresh or archived human tissue, either normal or pathological, that was removed as part of standard of care clinical procedures and/or during procedures performed for separate research purposes, such as a therapeutic clinical trial. Prospectively collected and archived pathology samples will be obtained under informed consent from those patients who are still living. The tissue repository will be de-identified. The PI and the RRP Foundation will collaborate and serve as the gatekeepers of the repository and oversee any tissue requests. Any academic collaborator(s) or for-profit collaborator(s) can request access to the tissue specimens. The investigator or collaborators should submit a letter to express interest in obtaining tissue from the tissue repository to the RRP Foundation and the PI.
- Medical subject headings
- Recurrent respiratory papillomatosis, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with HPV 6 or 11 infection in the pulmonary lesions
HPV 6 and 11 genotyping will be done via polymerase chain reaction
Measured: 24 months
Number of Participants with different mutational profiles in the matched laryngeal and pulmonary lesions
Sequencing of the HPV genome in the matched laryngeal and pulmonary lesions will be performed.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 Apr 2024
- Primary completion14 Apr 2026 (estimated)
- Study completion15 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Pai, MD, PhD, Massachusetts General Hospital
- Investigators
- Sara Pai, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412172
- Sponsor's protocol ID
- HIC# 2000037079
- Status last verified
- Aug 2025
- First submitted
- 14 Apr 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)
- ClinicalTrials.gov ID
- NCT06412172
- Acronym / sponsor ID
- HIC# 2000037079
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 14 Apr 2026 (estimated)
- Study completion
- 15 Apr 2030 (estimated)
- First posted
- 14 May 2024 (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.
Recurrent respiratory papillomatosis (RRP) is an orphan disease that affects approximately 20,000 people in the United States and is caused by infection with human papillomavirus (HPV) types 6 and 11. Since RRP is an orphan disease, it is an understudied disease entity with correspondingly few treatment options. The investigators hypothesize that by understanding the biology of RRP and the failed host immune responses against HPV, novel and rational therapies can be developed. This study will examine the genetic and immunologic alterations found in these rare tumors and distant metastatic involved sites (such as the lung) in patients diagnosed with RRP.
Detailed description
Since RRP is an orphan disease, any single institution or hospital treats a limited number of RRP patients. The primary purpose for establishing a tissue repository is to collect RRP tissue from various institutions and hospitals and to provide investigators access to a large number of RRP tissues to perform genetic and immunologic studies of these rare tumors. This is both a prospective and retrospective tissue collection repository. Tissue that will be collected will include excess fresh or archived human tissue, either normal or pathological, that was removed as part of standard of care clinical procedures and/or during procedures performed for separate research purposes, such as a therapeutic clinical trial. Prospectively collected and archived pathology samples will be obtained under informed consent from those patients who are still living. The tissue repository will be de-identified. The PI and the RRP Foundation will collaborate and serve as the gatekeepers of the repository and oversee any tissue requests. Any academic collaborator(s) or for-profit collaborator(s) can request access to the tissue specimens. The investigator or collaborators should submit a letter to express interest in obtaining tissue from the tissue repository to the RRP Foundation and the PI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with HPV-associated RRP. The investigators will collect, store, and study primary tissue and distant anatomic sites of disease which were removed as part of standard of care.
Key inclusion criteria (2 listed)
- History of HPV-associated Recurrent Respiratory Papillomatosis
- Has pulmonary lesions
Key exclusion criteria (1 listed)
- None
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
Number of Participants with HPV 6 or 11 infection in the pulmonary lesions
Time frame: 24 months
HPV 6 and 11 genotyping will be done via polymerase chain reaction
Number of Participants with different mutational profiles in the matched laryngeal and pulmonary lesions
Time frame: 24 months
Sequencing of the HPV genome in the matched laryngeal and pulmonary lesions will be performed.
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 12 Aug 2025.
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Recurrent Respiratory Papillomatosis (RRP)
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.
Marcelle Stiff contact
Sara Pai principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Respiratory Papillomatosis and Pulmonary Neoplasm, run by Massachusetts General Hospital at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Sara Pai, MD, PhD (203-785-5820, RRPBiorepository@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with HPV 6 or 11 infection in the pulmonary lesions (time frame: 24 months). The study lists 2 primary outcomes in all. 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 12 Aug 2025.