The Vanguard Study: Testing a New Way to Screen for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24,000
- 试验地点
- 44
- 主要终点
- Feasibility of enrollment onto study
研究概览
简要总结
The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).
详细描述
PRIMARY OBJECTIVES:
I. Assess the feasibility of recruitment and adherence to protocol-required baseline and follow-up data and blood collection.
II. Assess the feasibility of achieving representative enrollment across participating recruitment sites.
SECONDARY OBJECTIVES:
I. To assess the impact of participant blinding on willingness to participate, adherence to protocol required baseline and follow-up data, blood collection, and rates of standard of care screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
Four ACCESS Hubs will institute participant blinding to their randomly assigned group. Participants recruited in the remaining ACCESS Hubs will be told the arm to which they have been assigned. The purpose of having some Hubs institute blinding and others unblinded is to assess the impact of blinding on recruitment, participation in standard of care cancer screening, and adherence to the study protocol.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 45-75 years old
- •Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment
- •Agree to allow collection of information from their medical records for study-related purposes
- •Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic
- •Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion
排除标准
- •Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years
- •Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible. Persons with a history of prostate cancer that has not been treated are not eligible, regardless of when the diagnosis occurred
- •Ongoing cancer diagnostic work-up
- •Ongoing participation in another study of an investigational cancer screening test or technology not currently utilized in routine clinical practice
- •Currently breastfeeding or pregnant, or planning to become pregnant in the next year
- •History of solid organ or hematopoietic transplantation at any time, or blood transfusion within the last 30 days
研究组 & 干预措施
Arm II (Avantect MCD test)
Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Device Usage (Device)
Arm II (Avantect MCD test)
Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Biospecimen Collection (Procedure)
Arm II (Avantect MCD test)
Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Questionnaire Administration (Other)
Arm I (Shield MCD test)
Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Questionnaire Administration (Other)
Arm I (Shield MCD test)
Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Electronic Health Record Review (Other)
Arm II (Avantect MCD test)
Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Multi-Cancer Detection Test (Procedure)
Arm II (Avantect MCD test)
Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Electronic Health Record Review (Other)
Arm I (Shield MCD test)
Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Biospecimen Collection (Procedure)
Arm III (Control)
Participants undergo blood collection at enrollment and after one year on study.
干预措施: Biospecimen Collection (Procedure)
Arm I (Shield MCD test)
Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Device Usage (Device)
Arm III (Control)
Participants undergo blood collection at enrollment and after one year on study.
干预措施: Electronic Health Record Review (Other)
Arm III (Control)
Participants undergo blood collection at enrollment and after one year on study.
干预措施: Questionnaire Administration (Other)
Arm I (Shield MCD test)
Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
干预措施: Multi-Cancer Detection Test (Procedure)
结局指标
主要结局
Feasibility of enrollment onto study
时间窗: At time of randomization
The number of participants enrolled into the study compared to trial goals.
Proportion of participants who complete baseline and follow-up questionnaires within 60 days of receipt
时间窗: Up to 3 years
The proportion of participants who are complete questionnaires and timing of completion.
Proportion of participants who provide the required blood sample for year 1 for Multi-Cancer Detection (MCD) testing within 90 days of recommended time point
时间窗: Up to 2 years
The proportion of participants who have a second blood draw and the timing of the blood draw.
Proportion of participants considered lost to follow-up within 2 years of randomization
时间窗: Up to 2 years
The proportion of participants who do not complete study procedures and are not able to be contacted.
Representative enrollment
时间窗: Up to 2 years
Meeting or exceeding the trial enrollment goals on a population basis.
Staggered start of intervention arm 2
时间窗: Up to 1 year
Advantages and challenges arising from trial activation with one intervention arm and later addition of a second intervention arm.
次要结局
- Factors contributing to lack of diagnostic resolution of an abnormal MCD test(Up to 2 years)
- Contamination(Up to 3 years)
- Effects of participant characteristics(Up to 2 years)
- Complications related to diagnostic evaluation of an abnormal MCD test result(Up to 1 year)
- Anxiety and Cancer Worry Questionnaire(Up to 2 years)
- Specificity of each MCD assay(1 year)
- Effects of participant characteristics(Up to 2 years)
- Impact of participant blinding(Up to 2 years)
- Timely return of MCD test result(Up to 2 years)
- Factors contributing to lack of diagnostic resolution of an abnormal MCD test(Up to 2 years)
- Contamination(Up to 3 years)
- Diagnostic resolution following an abnormal MCD test result(Within 12 months following an abnormal MCD test result)
- Time to diagnostic resolution(Up to 2 years)
- Participation in standard of care screening(Up to 2 years)
- Accuracy of tissue of origin prediction(Up to 2 years)
- Complications related to diagnostic evaluation of an abnormal MCD test result(Up to 1 year)
- Anxiety and Cancer Worry Questionnaire(Up to 2 years)
- Sensitivity of clinical diagnostic performance of each MCD assay(Up to 2 years)
- Test positive rates(Up to 2 years)
- False positives(Up to 2 years)
- (Targeted cancer) Positive predictive value (PPV)(Up to 2 years)
- (All cancer) PPV(Up to 2 years)
- Interval cancers(1 year)
- Detected cancers(1 year)
- (Targeted cancer) Negative predictive value(1 year)