The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)

NCT06412172 | Recruiting

• 1 other identifier: HIC# 2000037079
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Recurrent Respiratory Papillomatosis; Pulmonary Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  24 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• History of HPV-associated Recurrent Respiratory Papillomatosis
• Has pulmonary lesions

You may not qualify if:

• None

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin embedded tissue and/or unstained slides.

MeSH Terms

Conditions

Recurrent respiratory papillomatosis; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sara Pai

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Pai, MD, PhD

CONTACT

203-785-5820; RRPBiorepository@yale.edu

Marcelle Stiff

CONTACT

mstiffpulmonary@rrpf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgeon

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: May 14, 2024
• Study Start: April 15, 2024
• Primary Completion: April 14, 2026
• Study Completion (Estimated): April 15, 2030
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (1)