Pancreatic Cancer Clinical Trial
— NODMEDOfficial title:
New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
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.
Status | Recruiting |
Enrollment | 6500 |
Est. completion date | December 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: = 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) Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | JEM Research Institute - Headlands - PPDS | Atlantis | Florida |
United States | Prisma Health/Endocrinology specialist and Thyroid | Greenville | South Carolina |
United States | Manassas Clinical Research Center | Manassas | Virginia |
United States | Headlands Research - Scottsdale - PPDS | Scottsdale | Arizona |
United States | Consano Clinical Research, LLC | Shavano Park | Texas |
Lead Sponsor | Collaborator |
---|---|
Bluestar Genomics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive Predictive Value (PPV) | defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result. | 12 months or until diagnostic resolution | |
Primary | Negative Predictive Value (NPV) | defined as the proportion of participants with no pancreatic neoplasia diagnosis out of all the subjects with pancreatic signal "not detected" test results. | 12 months or until diagnostic resolution | |
Primary | Specificity | defined as the proportion of participants with pancreatic signal "not detected" results out of all subjects with no pancreatic neoplasia diagnosis. | 12 months or until diagnostic resolution | |
Secondary | Time to pancreatic cancer diagnosis | Median time to pancreatic cancer diagnosis (using Pancreatic Cancer Signal Detection testing) relative to new onset diabetes (NOD) diagnosis compared to Median time to pancreatic cancer diagnosis relative to NOD diagnosis in the absence of Pancreatic Cancer Signal Detection testing, based on published data | 12 months or until diagnostic resolution | |
Secondary | Stage Shift | Stage Shift in NODs with Pancreatic Cancer in subjects that have undergone Pancreatic Cancer Signal Detection testing vs subjects without Pancreatic Cancer Signal Detection testing | 12 months or until diagnostic resolution |
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