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Recruiting

NCT Number: NCT06412172

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location status: Recruiting

Location contact

Sara Pai, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of HPV-associated Recurrent Respiratory Papillomatosis
  • Has pulmonary lesions

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Number of Participants with HPV 6 or 11 infection in the pulmonary lesions

    Time frame: 24 months

    HPV 6 and 11 genotyping will be done via polymerase chain reaction

  2. Number of Participants with different mutational profiles in the matched laryngeal and pulmonary lesions

    Time frame: 24 months

    Sequencing of the HPV genome in the matched laryngeal and pulmonary lesions will be performed.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcelle Stiff

CONTACT

[email protected]

Sara Pai, MD, PhD

CONTACT

[email protected]

203-785-5820

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
May 14, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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