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Cancer Screening Test
Early Detection Test + MRI for Pancreatic Cancer (NODMED Trial)
N/A
Recruiting
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
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)
No history of pancreatic cancer or other known pancreatic neoplasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months or until diagnostic resolution
Awards & highlights
NODMED Trial Summary
This trialevaluates a new test that can detect pancreatic cancer in people 50+ with type 2 diabetes. Participants will have the test & MRI to confirm results. 6,550 newly diagnosed Type 2 diabetics will take part.
Who is the study for?
This trial is for people over 50 with new onset type II diabetes, who have not had pancreatic cancer or other pancreatic diseases. Participants must be willing to give blood samples and have no active cancers in the past 5 years (except certain skin cancers). They cannot join if they've been treated for diabetes before, are currently pregnant, have significant health issues that could affect their participation, or have used steroids or undergone major surgery recently.Check my eligibility
What is being tested?
The NODMED trial is testing a non-invasive test by Bluestar Genomics for early detection of hidden pancreatic cancer in patients newly diagnosed with type II diabetes. If the test indicates possible cancer, an MRI will confirm its presence. This study involves regular follow-ups and imaging tests to monitor participants' health status.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures like blood tests and MRI imaging rather than medication or invasive treatments, side effects are minimal but may include discomfort from needle insertion during blood draws and claustrophobia or discomfort during MRI scans.
NODMED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had two high blood sugar readings in the last 90 days outside of a hospital.
Select...
I have never had pancreatic cancer or any known pancreatic tumors.
Select...
I am 50 years old or older.
NODMED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months or until diagnostic resolution
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 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
Negative Predictive Value (NPV)
Positive Predictive Value (PPV)
Specificity
Secondary outcome measures
Stage Shift
Time to pancreatic cancer diagnosis
NODMED Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pancreatic Cancer Signal Detection = DetectedExperimental Treatment1 Intervention
Subjects with test results "detected" will undergo MRI/Imaging
Group II: Pancreatic Cancer Signal Detection = Not DetectedActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Bluestar Genomics Inc.Lead Sponsor
2 Previous Clinical Trials
16,500 Total Patients Enrolled
ClearNote HealthLead Sponsor
2 Previous Clinical Trials
16,500 Total Patients Enrolled
Kelly Bethel, MDPrincipal InvestigatorBluestar Genomics
1 Previous Clinical Trials
10,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had HIV/AIDS, Hepatitis A or E, TB, or any prion disorder in the last 5 years.I haven't had surgery with general anesthesia in the last 2 months.I have been diagnosed with diabetes or have been on diabetes medication for at least 91 days.I have not had any local anesthetic in the last week.I've had cancer treatment in the last 5 years, or I'm being checked for cancer coming back.I have not had immunotherapy in the last year.You have been diagnosed with diabetes at least 91 days before joining the study. If you had gestational diabetes in the past but it went away, you cannot join.I have not had a blood transfusion in the last month.I have received an organ transplant.I have had two high blood sugar readings in the last 90 days outside of a hospital.My blood sugar levels were normal in the last 3-18 months.I have a pancreatic condition that is not diabetes.I am currently taking oral steroids regularly.I haven't had steroid injections into a joint less than a week before my qualifying blood test.I have never had pancreatic cancer or any known pancreatic tumors.I am 50 years old or older.I have been diagnosed with diabetes mellitus.I haven't had any active cancers in the last 5 years, except for non-melanoma skin cancers or in situ cancers treated over a year ago.
Research Study Groups:
This trial has the following groups:- Group 1: Pancreatic Cancer Signal Detection = Detected
- Group 2: Pancreatic Cancer Signal Detection = Not Detected
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.
How many participants is this research endeavor accommodating?
"Affirmative. The clinicaltrials.gov portal shows that this experiment is actively recruiting participants, first posted on October 31st 2022 and last updated November 1st 2022. 6500 individuals will be recruited from a single site."
Answered by AI
Is enrollment currently open for this clinical experimentation?
"Affirmative. According to information hosted on clinicaltrials.gov, the trial which began recruiting participants on October 31st 2022 is still actively looking for 6500 individuals from one medical centre."
Answered by AI
Who else is applying?
What site did they apply to?
JEM Research Institute - Headlands - PPDS
What portion of applicants met pre-screening criteria?
Did not meet criteria
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