New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Positive Predictive Value (PPV)
研究概览
简要总结
Bluestar Genomics has developed a non-invasive test that aids in detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older. The purpose of this study is to evaluate the performance of Bluestar Genomics early-detection pancreatic cancer test in a clinical setting. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the test returns a pancreatic cancer signal "detected" result the study participant will undergo MRI imaging to evaluate for the presence of pancreatic cancer. The study is planned to enroll 6,550 newly diagnosed type 2 diabetic subjects according to inclusion and exclusion criteria.
详细描述
This is a prospective longitudinal and interventional study of the Bluestar Genomics early detection pancreatic cancer test. The test will be ordered and results returned to site-investigators. The study is planned to enroll 6,550 male and female, ≥ 50 years of age and newly diagnosed with type II diabetes (within 90 days prior to enrollment). NOD subjects will be assessed for eligibility and consented. Each subject can undergo up to 2 blood draws and electronic medical record search at 12 months from diabetes diagnosis.
The study population will be targeted to enroll a subjects with a BMI < 32. Subjects ≥ 50 years of age will be divided into two cohorts based on age as described below:
Cohort 1 = 65 years old or older Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1.
Cohort 2 = 50 - 64 years old Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1.
Imaging Strategy MRI imaging (or alternate imaging if subject is unable to undergo MRI) will be performed on subjects whose test result is "detected".
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 50 years of age or older at the time of enrollment
- •Willing to sign the informed consent form
- •Must have 2 occurrences from among the below parameters of diabetes mellitus (PDMs) in past 90 days measured in outpatient setting (not in urgent care, emergency room or while inpatient):
- •FBG ≥126mg/dl HbA1c ≥6.5% RBG ≥ 200mg/dl 2-hour post-glucose ≥200mg/dl (OGTT)
- •Must have had glycemic parameter measured in 3-18 months prior to screening that did NOT meet DM criteria
- •Must be willing to provide several tubes of blood without endangering health
- •No history of pancreatic cancer or other known pancreatic neoplasia
- •No active cancers within the past 5 years (with the exception of non-melanoma skin cancers resolved/treated > 1 year prior to enrollment and in situ cancers)
排除标准
- •Prior DM diagnosis
- •Met criteria for DM ≥91 days prior to enrollment (patients with prior gestational diabetes that has resolved are NOT acceptable to enroll)
- •Carried a DM diagnosis or used anti-DM medications at a time greater than or equal to 91 days prior to enrollment
- •Any known pancreatic lesions (aside from diabetes)
- •Received cancer treatment within the past 5 years (with the exception of treatment of non-melanoma skin cancer), carrying a current cancer diagnosis, and/or being investigated for suspicion of past cancer recurrence.
- •Current chronic or acute oral steroid use
- •History of intra-articular steroid injections (<1 week) of the qualifying DM blood test (allowed exception: nasal, topical, oral budesonide)
- •Any surgery requiring general anesthesia within 2 months of collection
- •Local anesthetic (including dental novocaine) within 1 week of collection
- •History or presence of HIV/AIDs, Hepatitis A or E within the past five years, TB, any kind of prion disorder (e.g., CJD)
- •Blood transfusion within 1 month
- •Organ transplant recipient
- •Currently pregnant, or pregnancy within last 12 months
- •Receipt of systemic immunomodulation therapy within past 12 months
- •Significant medical condition that in the site investigator's opinion would compromise the subject's ability to tolerate study interventions
结局指标
主要结局
Positive Predictive Value (PPV)
时间窗: 12 months or until diagnostic resolution
defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result.
Negative Predictive Value (NPV)
时间窗: 12 months or until diagnostic resolution
defined as the proportion of participants with no pancreatic neoplasia diagnosis out of all the subjects with pancreatic signal "not detected" test results.
Specificity
时间窗: 12 months or until diagnostic resolution
defined as the proportion of participants with pancreatic signal "not detected" results out of all subjects with no pancreatic neoplasia diagnosis.
次要结局
- Time to pancreatic cancer diagnosis(12 months or until diagnostic resolution)
- Stage Shift(12 months or until diagnostic resolution)