Oropharynx (OPX) Biomarker Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Change in biomarkers
研究概览
简要总结
The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent.
详细描述
PRIMARY OBJECTIVE:
I. To identify a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls).
OUTLINE: This is an observational study.
Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Able to provide written consent
- •Groups 1-3:
- •Must undergo p16 staining on biopsy for enrollment
- •Patients with < 70% of tumor cells positive for p16 will be considered p16 negative
- •Must undergo HPV16 family in situ hybridization (ISH) and/or RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it
- •Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol
- •Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm
- •Primary salivary neoplasm
- •Primary thyroid neoplasm
- •Primary head and neck neoplasm
- •Multi-cancer early detection (MCED) testing concerning for cancer
- •Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Primary language: English, Spanish, Arabic
排除标准
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
- •Groups 1-3:
- •Other active malignancy ≤ 5 years prior to registration
- •EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal squamous cell carcinoma (SCC) (which can be enrolled in group 3)
- •NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
- •History of any head and neck malignancy, other than the tumor for which they are being treated
- •Group 4, Cohort A, B, C:
- •Other active malignancy ≤ 5 years prior to registration
- •EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma
- •NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- •History of any head and neck malignancy, other than the present neoplasm
- •Note these are clarifications of inclusion into Group 4, Cohorts D and E:
- •Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm
- •Receipt of cancer specific therapy for other malignancy is allowed in this arm
研究组 & 干预措施
Observational
Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Change in biomarkers
时间窗: Up to 24 months
Biospecimen samples will be assessed for a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls).
Oncologic outcomes associated with biomarkers
时间窗: Up to study completionUp to 24 months
Survival outcome (overall survival, disease-free survival, and distant failure) will be compared with blood, tissue and saliva biomarkers identified throughout the treatment course.
Genetic alterations
时间窗: Up to 24 months
Alterations in oropharynx tumor specimens will be compared with the detection rate of corresponding circulating DNA in oropharynx cancer patients throughout their treatment course
Immunologic biomarkers for diagnosis
时间窗: Up to 24 months
Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict diagnosis.
Immunologic biomarkers for prognosis
时间窗: Up to 24 months
Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict prognosis.
次要结局
未报告次要终点