The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of HPV-associated Recurrent Respiratory Papillomatosis
Has pulmonary lesions
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
24 months2
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.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov