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Cancer Detection Test
Pancreatic Cancer Detection Test for New-Onset Diabetes
N/A
Waitlist Available
Led By Kelly Bethel, MD
Research Sponsored by Bluestar Genomics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of pancreatic cancer
≥50 years of age or older at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months or until diagnostic resolution
Awards & highlights
Study Summary
This trial is testing a new, non-invasive method to detect pancreatic cancer in patients with type II diabetes who are 50 years old or older.
Who is the study for?
This trial is for people over 50 with new-onset type II diabetes who have never had pancreatic cancer or certain other pancreatic diseases. Participants must not have a history of any active cancers in the past five years (except some skin cancers and in situ carcinomas) and should be able to provide blood samples safely.Check my eligibility
What is being tested?
The study tests Bluestar Genomics' non-invasive early detection test for hidden pancreatic cancer in patients newly diagnosed with type II diabetes. If the test indicates potential cancer, an MRI will confirm its presence. The study aims to enroll 10,000 participants.See study design
What are the potential side effects?
Since this trial involves a diagnostic test rather than medication or invasive procedures, side effects are minimal but may include discomfort or bruising from blood draws and anxiety from testing results.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had pancreatic cancer.
Select...
I am 50 years old or older.
Select...
I have never had pancreatitis or any type of cysts in my pancreas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months or until diagnostic resolution
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months or until diagnostic resolution
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical performance of test: IPMNs sensitivity
Clinical performance of test: Specificity
Clinical performance of test: pancreatic cancer sensitivity
Secondary outcome measures
Negative Predictive Value
Positive Predictive Value
Stage Shift
Trial Design
2Treatment groups
Experimental Treatment
Group I: EpiDetect ArmExperimental Treatment1 Intervention
Each subject can undergo to up to 3 blood draws; at the time of enrollment (T0), at 6 months (T1) and 12 months (T2) from diabetes diagnosis. After 24 months from diabetes diagnosis, a review of the electronic medical records (EMR) will be performed for all subjects with a "not detected" test result.
Group II: EpiDetect "not detected" MRI ArmExperimental Treatment1 Intervention
A pre-specified number of cases with test results "not detected" will be randomly selected, gender ratio and age matched to subjects with test results "detected" and will undergo MRI imaging at T0 (n=226), at T1 (n=208 ) at T2 (n=208 ) and 24 months (n=208) from diabetes diagnosis.
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Who is running the clinical trial?
Bluestar Genomics Inc.Lead Sponsor
2 Previous Clinical Trials
13,000 Total Patients Enrolled
ClearNote HealthLead Sponsor
2 Previous Clinical Trials
13,000 Total Patients Enrolled
Kelly Bethel, MDPrincipal InvestigatorBluestar Genomics
1 Previous Clinical Trials
6,500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood sugar levels have been checked within the last 3-18 months, and you do not meet the criteria for diabetes.I have not had HIV/AIDS, Hepatitis A or E, TB, or any prion disorder like CJD in the last 5 years.I have lesions in my pancreas.I have never had pancreatic cancer.I have been diagnosed with diabetes.You have been diagnosed with diabetes for at least 91 days before joining the study. If you had gestational diabetes that went away, you cannot enroll.I have not had any local anesthetic in the last week.I have received an organ transplant.I am 50 years old or older.I haven't had steroid injections into a joint less than a week before my qualifying blood test.I have never had pancreatitis or any type of cysts in my pancreas.I haven't had surgery with general anesthesia in the last 2 months.I have not had immunotherapy in the last year.I have not had a blood transfusion in the last month.I have been treated for cancer, excluding non-melanoma skin cancer, in the last 5 years.I am currently taking oral steroids regularly.I have had high blood sugar readings twice in the last 3 months.I haven't had any active cancers in the last 5 years, except for non-melanoma skin cancer or in situ carcinomas treated over a year ago.I have been diagnosed with diabetes or have been on diabetes medication for at least 91 days.
Research Study Groups:
This trial has the following groups:- Group 1: EpiDetect Arm
- Group 2: EpiDetect "not detected" MRI Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study currently seeking participants?
"The most recent edition of the clinicaltrial.gov data reveals that this particular study is not in need of patients at present. Initially posted on June 1st 2021 and last amended December 27th 2021, it is no longer accepting participants despite 701 other trials actively seeking volunteers."
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