Early Detection Initiative for Pancreatic Cancer

Status Enrolling by invitation

Clinical Trial Summary

The Early Detection Initiative for Pancreatic Cancer is a multi-center randomized controlled trial to determine if algorithm-based screening in patients with new onset hyperglycemia and diabetes can result in earlier detection of pancreatic ductal adenocarcinoma.

Clinical Trial Description

The Early Detection Initiative (EDI), is designed to evaluate if imaging at the time of new onset hyperglycemia and diabetes, especially at its earliest discovery through passive surveillance of the electronic medical record (EMR), results in earlier detection of pancreatic ductal adenocarcinoma (PDAC). Eligible patients are identified and enrolled based on a first-time elevation in fasting blood glucose or glycated hemoglobin (HbA1c) to the level indicating diabetes as derived from records in their EMR. All enrolled patients are randomized to either the Observational Arm or Intervention Arm of the study. Patients randomized to the Intervention Arm have Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated using age, body weight and glucose or glycated hemoglobin values in their EMR. Patients with high ENDPAC score (>0) are approached for informed consent to participate in up to two imaging studies by computerized tomography (CT) scan or magnetic resonance imaging (MRI). In addition to imaging, participants will be asked to complete study questionnaires and participate in serial blood collection at up to five time points. Blood samples collected in the EDI study will contribute to the National Institutes of Health (NIH) National Cancer Institute (NCI) biorepository located at the Frederick National Laboratory for Cancer Research facility. Patients in both study arms are followed for development of PDAC. This study is performed at locations with broad (institutional) consent for use of patient EMR information for research studies. Passive follow-up by EMR will occur for five years following enrollment. Any patient that has declined participation in EMR-based research at the institution is not included in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04662879
Study type	Interventional
Source	Pancreatic Cancer Action Network
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	October 14, 2021
Completion date	July 2030

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03743779` - Mastering Diabetes Pilot Study
Completed	`NCT03786978` - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus	N/A
Completed	`NCT01804803` - DIgital Assisted MONitoring for DiabeteS - I	N/A
Completed	`NCT05039970` - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT04068272` - Safety of Bosentan in Type II Diabetic Patients	Phase 1
Completed	`NCT03243383` - Readmission Prevention Pilot Trial in Diabetes Patients	N/A
Completed	`NCT03730480` - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)	N/A
Recruiting	`NCT02690467` - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.	N/A
Completed	`NCT02229383` - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus	Phase 3
Completed	`NCT06181721` - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes	N/A
Completed	`NCT05799976` - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure	N/A
Recruiting	`NCT04489043` - Exercise, Prediabetes and Diabetes After Renal Transplantation.	N/A
Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4
Completed	`NCT03542084` - Endocrinology Auto-Triggered e-Consults	N/A
Completed	`NCT02229396` - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo	Phase 3
Recruiting	`NCT05544266` - Rare and Atypical Diabetes Network
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed	`NCT05031000` - Blood Glucose Monitoring Systems: Discounter Versus Brand	N/A
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Early Detection Initiative for Pancreatic Cancer — EDI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms