Status:
UNKNOWN
EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
Lead Sponsor:
ClearNote Health
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Bluestar Genomics has developed a non-invasive test that aids in the qualitative detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older. ...
Detailed 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 st...
Eligibility Criteria
Inclusion
- ≥50 years of age or older at the time of enrollment
- Willing to provide and 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 without meeting DM criteria
- Must be willing to provide several tubes of blood without endangering health
- No history of pancreatic cancer
- No history of IPMNs, other neoplastic cysts and pancreatitis
- 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 carcinomas)
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT05188573
Start Date
June 1 2022
End Date
May 31 2025
Last Update
January 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bluestar Genomics, Inc.
San Diego, California, United States, 92121