Actively Recruiting

Age: 18Years - 99Years
All Genders
ID06412172

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

Led by Massachusetts General Hospital · Updated on 2025-08-12

100

Participants Needed

1

Research Sites

208 weeks

Total Duration

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AI-Summary

What this Trial Is About

Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus (HPV) types 6 and 11, affecting about 20,000 people in the United States. This research aims to better understand the biology and immune response failures in RRP, especially focusing on the genetic and immunologic features of these rare tumors and their spread to distant sites like the lungs. Because RRP is rare, it has limited treatment options and there is a need for more study to develop new therapies. This study involves collecting tissue samples from patients with RRP from various hospitals and institutions to create a tissue repository. Both fresh and archived tissues, whether normal or diseased, removed during standard care or other research procedures will be gathered. Living patients will provide informed consent for prospective samples. The repository will be de-identified and managed by the investigators and the RRP Foundation, who will oversee requests for tissue access from academic and for-profit researchers. Participants will contribute tissue samples that researchers will use to examine HPV infection in lung lesions and to study genetic mutations in both lung and laryngeal lesions over a 24-month period. The study does not involve treatment but focuses on tissue collection and analysis. The repository allows broad access for research to better understand RRP and support future studies. Participation duration depends on tissue availability and consent, with ongoing monitoring of genetic and immunologic changes in the collected samples.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of HPV-associated Recurrent Respiratory Papillomatosis
  • Has pulmonary lesions
  • Age between 18 and 99 years
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Ongoing throughout study participation

Tissue samples from routine clinical procedures are collected for genetic and immunologic studies of pulmonary recurrent respiratory papillomatosis.

Samples collected during routine care procedures as they occur

Long-term Monitoring

Duration - Up to 24 months

Participants are observed over time to study the natural history and biological characteristics of pulmonary recurrent respiratory papillomatosis using collected tissue specimens.

Follow-up assessments may occur depending on tissue collection and study needs

Trial Site Locations

Total: 1 location

1

Yale School of Medicine

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

S

Sara Pai, MD, PhD

M

Marcelle Stiff

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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