Recurrent Respiratory Papillomatosis Clinical Trial
Official title:
The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 15, 2030 |
Est. primary completion date | April 14, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - History of HPV-associated Recurrent Respiratory Papillomatosis - Has pulmonary lesions Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Yale School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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