Using Guardant ShieldTM to Facilitate Colorectal Cancer Screening in Under-screened Individuals in a Diverse Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months
研究概览
简要总结
The purpose of this research is to identify individuals overdue for colon cancer screening and send them a reminder to complete their screening, which includes standard of care colonoscopy or stool-based testing. The investigators are randomizing patients (like a flip of a coin) to either receive the standard reminder by mail/email or to receive the standard reminder and have the option to provide a blood sample for screening (ShieldTM by Guardant).
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
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 45 - 85 years of age at average risk and able to provide informed consent.
- •Patients overdue for a screening colonoscopy or stool-based test that was ordered by their University of Miami (UM) clinician.
排除标准
- •Impaired decision-making capability/unable to provide informed consent.
- •Patients with high-risk conditions:
- •Personal history of colorectal cancer (CRC), adenomas, or other cancers
- •Those who had a positive result on another CRC screening method within the last six months, an abnormal stool test that found blood in your stool within the last 12 months, or abnormal Cologuard (FIT-DNA Test) in the last 3 years
- •Those with Inflammatory Bowel Disease (IBD), chronic ulcerative colitis (CUC), Crohn's disease
- •Those who have a family history of colorectal cancer (in a parent, brother, sister, or child)
- •Genetic predisposition requiring more frequent screening (such as Lynch syndrome, IBD, history of colectomy, etc.)
- •Symptoms like rectal bleeding, weight loss, or other signs for which your doctor ordered a colonoscopy - not simply as a screening tool
研究组 & 干预措施
Reminder + Blood-Based Option Group
Participants in this group will receive a similar reminder, but with the additional option of completing a blood-based screening test (ShieldTM). Communication will be delivered via mailed letter or the UHealth patient portal.
Total participation duration is approximately nine (9) months.
干预措施: Screening Reminder (Behavioral)
Reminder-Only Group
Participants in this group will receive a standard screening reminder via mailed letter or, if they have an active patient portal account through the University of Miami health (UHealth) portal.
Total participation duration is approximately nine (9) months.
干预措施: Screening Reminder (Behavioral)
Reminder + Blood-Based Option Group
Participants in this group will receive a similar reminder, but with the additional option of completing a blood-based screening test (ShieldTM). Communication will be delivered via mailed letter or the UHealth patient portal.
Total participation duration is approximately nine (9) months.
干预措施: Blood Sample Collection (Procedure)
结局指标
主要结局
Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months
时间窗: Up to 6 months
Percentage of participants, between both arms, who complete colorectal cancer screening within 6 months.
次要结局
未报告次要终点
研究者
Shria Kumar
Associate Professor of Clinical
University of Miami