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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06412172
Other study ID # HIC# 2000037079
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT01020747 - Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP) Phase 1
Completed NCT00038714 - A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis Phase 2
Completed NCT00205374 - Use of Cidofovir for Recurrent Respiratory Papillomatosis Phase 4
Active, not recruiting NCT04724980 - Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis Phase 1/Phase 2
Not yet recruiting NCT04645602 - Lenvatinib and Pembrolizumab Combination Therapy In HPV-associated Recurrent Respiratory Papilloma Patients With Laryngeal, Tracheal, and/or Pulmonary Involvement Phase 2
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Withdrawn NCT01058317 - Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis Phase 2/Phase 3
Withdrawn NCT00829608 - Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis Phase 0
Completed NCT00550914 - Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP N/A
Not yet recruiting NCT01995721 - 4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children Phase 3
Completed NCT02217358 - Value of Narrow Band Imaging (NBI) Endoscopy in the Early Diagnosis of Laryngeal Cancer and Precancerous Lesions N/A
Completed NCT00571701 - Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis Phase 2
Recruiting NCT02555800 - Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis Phase 2
Completed NCT03707587 - M7824 in People With Recurrent Respiratory Papillomatosis Phase 2
Completed NCT02859454 - Avelumab for People With Recurrent Respiratory Papillomatosis Phase 2
Active, not recruiting NCT02632344 - Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients Phase 2
Completed NCT02592902 - Recurrent Respiratory Papillomatosis and Extraesophageal Reflux N/A
Recruiting NCT03465280 - Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)