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

Recurrent Respiratory Papillomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06412172
• Other study ID #: HIC# 2000037079
• Status: Recruiting
• Start date: April 15, 2024
• Est. completion date: April 15, 2030

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Sara Pai, MD, PhD
• Phone: 203-785-5820
• Email: RRPBiorepository[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lung Neoplasms
• Papilloma
• Papillomavirus Infections
• Pulmonary Neoplasm
• Recurrence
• Recurrent Respiratory Papillomatosis
• Respiratory Tract Infections

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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