Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412172
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-14
Brief Title:
The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis pRRP
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis pRRP
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recurrent respiratory papillomatosis RRP is an orphan disease that affects approximately 20000 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
Detailed 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 andor 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 collaborators or for-profit collaborators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None