Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens
研究概览
简要总结
This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and anogenital cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies or circulating HPV DNA may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.
详细描述
PRIMARY SCIENTIFIC OBJECTIVES:
I. To determine the association of antibodies to human papillomavirus type 16 (HPV16) early (E) antigens and circulating HPV16 DNA (cHPVDNA) with oral HPV16 prevalence.
II. To determine the association of antibodies to HPV16 E antigens and/or cHPVDNA with site-specific HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer).
III. To determine the association of 12-month persistence of oral rinse HPV16 DNA with site-specific oropharyngeal HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer).
EXPLORATORY SCIENTIFIC OBJECTIVE:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Stage 1 Inclusion Criteria: United States (US) resident
- •Stage 1 Inclusion Criteria: Fluent in English
- •Stage 1 Inclusion Criteria: Sign an approved informed consent document
- •Stage 2 (longitudinal study) Inclusion Criteria:
- •Eligible for and enrolled in Stage 1
- •Test positive to HPV16 E antibodies; be identified as a negative control; test positive for oral HPV16 infection by oral rinse; or test positive for cvDNA
- •Sign an approved informed consent document
排除标准
- •Stage 1 Exclusion Criteria: Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis
- •Stage 1 Exclusion Criteria: Received radiation cancer therapy to the head and neck in the past
- •Stage 1 Exclusion Criteria: On active cancer therapy now or in the past 6 months
- •Stage 1 Exclusion Criteria: Ever had a transplant (stem cell, bone marrow, or solid organ)
- •Stage 1 Exclusion Criteria: Patients who received blood transfusions in the last 6 months
- •Stage 1 Exclusion Criteria: Other medical or psychiatric illness or social situation that would limit study compliance
- •Stage 2 (longitudinal study) Exclusion Criteria: Any seronegative and cvDNA-negative man who tests negative for oral HPV16 DNA by swab and oral rinse at two consecutive follow-up visits will be excluded from further follow-up. Any man who is seropositive, cvDNA-positive, or has evidence of integration at any time will continue to be followed regardless of oral HPV16 status
研究组 & 干预措施
Screening (specimen collection, HPV testing)
STAGE I: Participants fill out a survey and undergo collection of blood and oral rinse samples.
STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, collection of oral rinse sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, penile exam, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, ultrasound, and blood sample collection once every year for 5 years. Select participants will provide oral rinse sample by mail every six months.
干预措施: Biomarker Analysis (Other)
Screening (specimen collection, HPV testing)
STAGE I: Participants fill out a survey and undergo collection of blood and oral rinse samples.
STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, collection of oral rinse sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, penile exam, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, ultrasound, and blood sample collection once every year for 5 years. Select participants will provide oral rinse sample by mail every six months.
干预措施: Biospecimen Collection (Procedure)
Screening (specimen collection, HPV testing)
STAGE I: Participants fill out a survey and undergo collection of blood and oral rinse samples.
STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, collection of oral rinse sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, penile exam, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, ultrasound, and blood sample collection once every year for 5 years. Select participants will provide oral rinse sample by mail every six months.
干预措施: Ultrasonography (Procedure)
结局指标
主要结局
Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens
时间窗: Up to 5 years
Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.
Cancer detection rate of the seropositive group
时间窗: Up to 5 years
Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.
次要结局
未报告次要终点
研究者
Erich Sturgis
Professor and Vice-Chair of Clinical Affairs, Dept of Otolaryngology-Head and Neck Surgery; Brown Foundation Endowed Chair; Head, Neck, & Thyroid Cancer Multidisciplinary Program Director
Baylor College of Medicine