NCT05334069招募中不适用
Blinded Reference Set for Multicancer Early Detection Blood Tests
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 745
- 主要终点
- Provision of blinded reference set of cancer versus non-cancer blood samples
研究概览
简要总结
This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.
详细描述
PRIMARY OBJECTIVE:
I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection.
SECONDARY OBJECTIVES:
I. Evaluate test performance at the time of initial cancer diagnosis by tumor type.
II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with a cancer diagnosis: Documentation of disease:
- •Histologic documentation: Histologically confirmed diagnosis of invasive cancer
- •Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma
- •For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia [AML])
- •For lymphoma: Stage I-IV based on Ann Arbor staging
- •For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)
- •One of the following tumor types:
- •Colorectal
- •Head and neck
- •Hepatobiliary
- •Ovary *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
- •Pancreas *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
- •Multiple myeloma
- •Gastric, esophageal or gastroesophageal
- •For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
- •Endometrium
- •*** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
- •Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention
- •Participants with a cancer diagnosis: Age >= 40 and =< 75
- •Participants with a cancer diagnosis: No known current pregnancy by self-report
- •Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
- •Participants with a cancer diagnosis: Willingness to provide blood samples for research use
- •Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL
- •Participants with a cancer diagnosis: No history of organ transplantation
- •Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish
- •* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
- •Participants without a cancer diagnosis and without suspicion of cancer: Age >= 40 and =< 75
- •Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report
- •Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)
- •Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use
- •Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
- •Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation
- •Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish
- •* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
- •Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw
- •* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma
- •Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs
- •Participants with a high suspicion of cancer: Age >= 40 and =< 75
- •Participants with a high suspicion of cancer: No known current pregnancy by self-report
- •Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
- •Participants with a high suspicion of cancer: Willingness to provide blood samples for research use
- •Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
- •Participants with a high suspicion of cancer: No history or organ transplantation
- •Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
排除标准
- 未提供
研究组 & 干预措施
Screening (questionnaire, biospecimen collection)
Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.
干预措施: Questionnaire Administration (Other)
Screening (questionnaire, biospecimen collection)
Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Provision of blinded reference set of cancer versus non-cancer blood samples
时间窗: Up to 1 year
Diagnostic ability will be assessed across the entire cohort of 2000 subjects by estimating the sensitivity and specificity with 95% confidence intervals.
次要结局
- Test performance at the time of initial cancer diagnosis by tumor type(Up to 1 year)
- Test performance at the time of initial cancer diagnosis by clinical stage(Up to 1 year)
研究者
研究点 (745)
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