Early Detection Initiative for Pancreatic Cancer (EDI)
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|ClinicalTrials.gov Identifier: NCT04662879|
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hyperglycemia Diabetes Mellitus Pancreas Ductal Adenocarcinoma||Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score Other: Abdominal imaging||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial with post-randomization consent|
|Official Title:||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)|
|Actual Study Start Date :||October 14, 2021|
|Estimated Primary Completion Date :||July 2030|
|Estimated Study Completion Date :||July 2030|
Experimental: Intervention Arm
Two interventions are performed:
Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score
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.
Other: Abdominal imaging
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.
No Intervention: Observation Arm
Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.
- Earlier detection of pancreatic ductal adenocarcinoma (PDAC) [ Time Frame: Baseline and approximately every six months for up to five years ]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.
- Smaller proportion of unresectable disease [ Time Frame: Baseline and approximately every six months for up to five years ]Determine if Intervention results in earlier detection of PDAC defined as a smaller proportion of unresectable disease.
- Less Stage IV disease [ Time Frame: Baseline and approximately every six months for up to five years ]Determine if Intervention results in earlier detection of PDAC defined as less Stage IV disease.
- Smaller proportion with advanced pancreatic cancer symptoms [ Time Frame: Baseline and approximately every six months for up to five years ]Determine if Intervention results in earlier detection of PDAC defined as a smaller proportion with advanced pancreatic cancer symptoms.
- Estimating risk in subgroups [ Time Frame: Baseline and approximately every six months for up to five years ]Estimate the risk of PDAC in NOD and Enriching New-onset Diabetes (or hyperglycemia) for Pancreatic Cancer (ENDPAC) subgroups.
- Validate ENDPAC model [ Time Frame: Baseline and approximately every six months for up to five years ]Prospectively validate the ENDPAC model.
- Over diagnosis due to imaging intervention of NOD [ Time Frame: Baseline and imaging follow-up visit, up to 9 months ]Determine the magnitude of over diagnosis due to imaging intervention of NOD.
- Determine the proportion of incidental findings [ Time Frame: Baseline and approximately every six months for up to five years ]Determine, on imaging in NOD, the proportion with incidental findings that require clinical workup.
- Contribute to NOD biobank [ Time Frame: Baseline and blood collection follow-up visits, up to 36 months ]Contribute blood biospecimens to a previously established NOD cohort biobank for future biomarker validation studies.
- Depression and Anxiety as early indicators [ Time Frame: Baseline and follow-up visits ]Determine if symptoms of depression and anxiety are early indicators of PDAC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662879
|Contact: Nadia Yosuf, MPHfirstname.lastname@example.org|
|Contact: Omer Mushtaq||(206) email@example.com|
|United States, California|
|Kaiser Permanente Southern California, Kaiser Permanente Research||Recruiting|
|Pasadena, California, United States, 91101|
|Contact: Soon Kyu Choi, MPP, MSc 888-203-5401 EDI@kp.org|
|Principal Investigator: Bechien Wu, MD|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Amy Wood, MPH 713-798-8960 firstname.lastname@example.org; email@example.com|
|Principal Investigator: William Fisher, MD|
|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 Center|
|Study Director:||Jackie Dahlgren||Fred Hutchinson Cancer Center|