Neoplasms

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Body Weight

Hyperglycemia

Metabolic Diseases

Glucose Metabolism Disorders

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Two interventions are performed:

1. Have Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated, and if Score is \>0,
2. Have abdominal imaging performed.

Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.

ENDPAC is a model to risk-stratify patients with new onset diabetes and hyperglycemia for PDAC. Score is calculated using i) age, ii) change, over past year, in body weight and iii) change, over past year, in glucose/HbA1c values obtained from the electronic medical record.

Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score

Using computerized tomography (CT) scan or magnetic resonance imaging (MRI), if CT scan is contra-indicated, patients with a high ENDPAC score (\>0) are approached for informed consent to participate in the imaging intervention. Imaging (CT scan) is performed at up to two time points, study baseline and approximately 3-9 months following the first imaging study.

Abdominal imaging

Suresh Chari, MD

Anirban Maitra, MBBS

Bechien Wu, MD

Avinash Kambadakone-Ramesh, MD, FRCR

Ziding Feng, PhD

Jackie Dahlgren

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.

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.

Randomized controlled trial with post-randomization consent

Early Detection Initiative for Pancreatic Cancer

A Randomized Controlled Trial of Algorithm-based Screening in Patients With New Onset Hyperglycemia and Diabetes for Early Detection of Pancreatic Ductal Adenocarcinoma (Early Detection Initiative (EDI) for Pancreatic Cancer)

Determine if algorithm-based screening in new onset hyperglycemia and diabetes (NOD) results in earlier detection of pancreatic ductal adenocarcinoma (PDAC) as evidenced by a lower proportion of Stage III/IV disease at the time of PDAC diagnosis in intervention vs observation arm.

Determine if Intervention results in earlier detection of PDAC defined as a smaller proportion of unresectable disease.

Determine if Intervention results in earlier detection of PDAC defined as less Stage IV disease.

Determine if Intervention results in earlier detection of PDAC defined as a smaller proportion with advanced pancreatic cancer symptoms.

Estimate the risk of PDAC in NOD and Enriching New-onset Diabetes (or hyperglycemia) for Pancreatic Cancer (ENDPAC) subgroups.

Determine the magnitude of over diagnosis due to imaging intervention of NOD.

Determine, on imaging in NOD, the proportion with incidental findings that require clinical workup.

Contribute blood biospecimens to a previously established NOD cohort biobank for future biomarker validation studies.

Determine if symptoms of depression and anxiety are early indicators of PDAC.

Spots Global Cancer Trial Database for endpac score

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