Early Detection Initiative for Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus
- Hyperglycemia
- Pancreas Ductal Adenocarcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled trial with post-randomization consentMasking: Single (Participant)Primary Purpose: Screening
Participation Requirements
- Age
- Between 50 years and 85 years
- Gender
- Both males and females
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 (PD...
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.
Tracking Information
- NCT #
- NCT04662879
- Collaborators
- Fred Hutchinson Cancer Research Center
- National Institutes of Health (NIH)
- Investigators
- Study Chair: Suresh Chari, MD M.D. Anderson Cancer Center Principal Investigator: Anirban Maitra, MBBS M.D. Anderson Cancer Center Principal Investigator: Bechien Wu, MD Kaiser Permanente Principal Investigator: Avinash Kambadakone-Ramesh, MD, FRCR Massachusetts General Hospital Principal Investigator: Ziding Feng, PhD Fred Hutchinson Cancer Research Center