Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062285) titled 'A Multicenter Study Using Gargle Samples to Detect Early HPV-Related Tonsillar Lesions' on July 21.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - HPV-related early tonsillar lesions, including HPV-related precancerous lesions and early-stage cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - To identify HPV-related precancerous lesions and early-stage cancer, collectively defined as HPV-related early tonsillar lesions, in resected tonsils from patients undergoing tonsillectomy for benign diseases, and to determine the diagnostic performance of high-risk HPV E6/E7 mRNA in preoperative gargle samples by comparing the assay results with the presence or absence of HPV-related early tonsillar lesions. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria are eligible:

1. Patients scheduled to undergo tonsillectomy for a benign disease 2. Eastern Cooperative Oncology Group Performance Status of 0 or 1 3. Age 18 years or older and younger than 85 years at the time of informed consent 4. Written informed consent to participate in the study provided by the patient Key exclusion criteria - Patients who meet any of the following criteria will be excluded:

1. A history of bilateral tonsillectomy or radiotherapy to the oropharynx 2. A psychiatric disorder or psychiatric symptoms that interfere with daily activities and make participation in the study difficult 3. Patients considered unsuitable for participation in the study by the investigator for any other reason Target Size - 2000

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 06 Month 23 Day Date of IRB - 2025 Year 07 Month 24 Day Anticipated trial start date - 2025 Year 11 Month 18 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071252

Disclaimer: Curated by HT Syndication.