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

NCT ID: NCT06412172

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2030-04-15

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.

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.

Conditions

Recurrent Respiratory Papillomatosis; Pulmonary Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sara Pai, MD, PhD

Associate Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Pai

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara Pai, MD, PhD

Role: CONTACT

RRPBiorepository@yale.edu

203-785-5820

Marcelle Stiff

Role: CONTACT

mstiffpulmonary@rrpf.org

Facility Contacts

Sara Pai, MD, PhD

Role: primary

Other Identifiers

HIC# 2000037079

Identifier Type: -

Identifier Source: org_study_id