Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06412172

Conditions

Recurrent Respiratory Papillomatosis

Pulmonary Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06412172

Start date

Apr 15, 2024

Status verified date

Aug, 2025

Completion date

Apr 15, 2030

Anticipated

Primary completion date

Apr 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of Participants with HPV 6 or 11 infection in the pulmonary lesions [ Time Frame: 24 months ]
  • Number of Participants with different mutational profiles in the matched laryngeal and pulmonary lesions [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-08-12.