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Clinical Trial Summary

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 assay 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 2,500 newly diagnosed type 2 diabetic subjects according to inclusion and exclusion criteria.


Clinical Trial Description

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 2,500 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 minimum of 50% of subjects with a BMI < 32. Subjects ≥ 50 years of age will be divided into two cohorts based on age, and the study will include a negative control arm 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. Negative Control Arm The negative control arm consists of randomly selected "not-detected" subjects who will be sent for MRI imaging at each of the three study timepoints, with four "non-detected" subjects imaged for each "detected" subject imaged. At T0 and T1, the subjects in the negative control arm will be pre-specified according to gender and age-matched (within 5 years) to the subjects who tested "detected" at 4:1 ratio. Since testing will not occur at T2, subjects who were "not-detected" at T0 and T1 and showed no evidence of cancer after 12-month EMR review will be gender and age matched (within 5 years) to the "detected" subjects at T1 at 4:1 ratio. Imaging Strategy MRI imaging (or alternate imaging if subject is unable to undergo MRI) will be performed oin subjects whose test result is "detected", and for the pre-specified test negative control arm subjects. If the imaging study results are abnormal, the subject will be referred back to their enrolling clinician for additional diagnostic work up as part of routine healthcare. If pancreatic cancer or other pancreatic lesion is diagnosed, the diagnostic reports will be collected as part of the study clinical data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05188586
Study type Interventional
Source Bluestar Genomics Inc.
Contact Anna Bergamaschi, PhD
Phone 650-714-9212
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date April 1, 2022
Completion date April 1, 2024

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