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Clinical observation of the benefit of HPV vaccination in patients with recurrent respiratory papilloma (RRP)

Clinical observation of the benefit of HPV vaccination in patients with recurrent respiratory papilloma (RRP)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103158
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent respiratory papillomatopathy

Interventions

Observation group:N/A
Mixed control group:N/A

Sponsors

Beijing Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
9 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for the observation group: (1) Age 9-45 years old, divided into four age groups: 9-17 years old, 18-26 years old, 27-35 years old, and 36-45 years old (including the cut-off value) to match the cases in the control group; (2) female; (3) Papillomatous lesions can be seen in the respiratory tract, and recurrent respiratory papillomatosis is diagnosed, or papilloma is confirmed by pathology; (4) Have completed the three-dose standard immunization schedule and have been 7-12 months since the first dose; (5) The total number of surgeries before enrollment was divided into five ranges: 0-5, 6-10, 11-15, 16-20 (including the cut-off value) and more than 20 to match the cases in the control group; (6) Patients who are positive for HPV vaccine coverage type infection (i.e., HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 are positive for any type), and match control cases according to HPV type. 2. Inclusion criteria for the control group: (1) Age 9-45 years old, divided into four age groups: 9-17 years old, 18-26 years old, 27-35 years old, and 36-45 years old (including the cut-off value) for matching cases in the observation group; (2) female; (3) Papillomatous lesions can be seen in the respiratory tract, and recurrent respiratory papillomatosis is diagnosed, or papilloma is confirmed by pathology; (4) Previously or contemporaneously underwent surgery in our hospital and have not been vaccinated against HPV; (5) The number of surgeries before enrollment was divided into five ranges: 0-5, 6-10, 11-15, 16-20 (including the cut-off value) and more than 20 cases. (6) Patients who are positive for HPV vaccine coverage type infection (i.e., HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 are positive for any type), and the cases in the observation group are matched according to the HPV type.

Exclusion criteria

Exclusion criteria: (1) Those who have received other adjuvant therapy in the past, such as bevacizumab, interferon, traditional Chinese medicine, etc.; (2) Those with a history of gastrointestinal perforation, severe bleeding, arterial thromboembolism, chemical drugs, and radiotherapy in the past; (3) Patients with severe heart, liver and kidney insufficiency or other contraindications to drugs; (4) Those with a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, and poor compliance; (5) Those who have been immunosuppressed or potentially immunosuppressed in the past, or are currently immunocompromised, or have been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases; (6) Those who have undergone splenectomy in the past; (7) Pregnant and lactating females who have no plans to become pregnant in the next 1 year; (8) Unable to complete regular endoscopy after surgery, incomplete medical records and imaging data, or refusal of the patient's family members and guardians to participate in this study; (9) Known hypersensitivity reaction to HPV vaccine.

Design outcomes

Primary

MeasureTime frame
Changes in the rate of tumor proliferation;

Secondary

MeasureTime frame
Cohen grading;VHI score;GRBAS score;Evaluation of lung lesions;Assessment of dyspnea;

Countries

China

Contacts

Public ContactJun Wang

Beijing Tongren Hospital

18910137727@163.com+86 189 1013 7727

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026