2021-10-14
2028-01
2028-01
8869
NCT04662879
Pancreatic Cancer Action Network
Pancreatic Cancer Action Network
INTERVENTIONAL
Early Detection Initiative for Pancreatic Cancer
The Early Detection Initiative for Pancreatic Cancer is a multi-center prospective study to determine if algorithm-based screening in patients with glycemically defined new onset hyperglycemia and diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma.
The Early Detection Initiative (EDI), is designed to prospectively evaluate the performance characteristics of the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) model to enrich glycemically defined new-onset diabetes for pancreatic cancer. The study will also determine with elevated ENDPAC score occurs at a clinically meaningful lead time (>/= 4 months) before pancreatic cancer diagnosis. Eligible patients are identified and enrolled based on a first-time elevation in fasting blood glucose parameters or glycated hemoglobin (HbA1c) to the level indicating glycemically defined new-onset diabetes as derived from records in their EMR. At sites performing the Intervention component of the study, all enrolled participants will have the 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 a study questionnaire. At sites that do not perform the Intervention component of the study, participants will be identified, enrolled, and followed by EMR data only. All enrolled participants 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 three years following enrollment. Any patient that has declined participation in EMR-based research at the institution is not included in the study.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2020-11-20 | N/A | 2025-06-04 |
2020-12-04 | N/A | 2025-06-08 |
2020-12-10 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Screening
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Intervention Arm (Site) 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. | OTHER: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score
OTHER: Abdominal imaging
|
NO_INTERVENTION: Observation Arm (Site) Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis. |
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Validate the ENDPAC model | Prospectively validate the ENDPAC model. | Baseline and approximately every six months for up to three years |
Quantify potentially clinically meaningful lead time for earlier detection of PDAC | Measure the duration from G-NOD to date of clinical diagnosis of PDAC. | Baseline and approximately every six months for up to three years |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Evaluate the risk of PDAC in G-NOD | Estimate the risk of PDAC in G-NOD in the average risk population including potentially clinically meaningful lead time for earlier detection of PDAC. | Baseline and approximately every six months for up to three years |
Proportion of incidental findings on imaging | Evaluate, on imaging at the time of G-NOD, the proportion with incidental findings including those that require clinical work-up. | Baseline and imaging follow-up visit, up to 9 months |
Risk of PDAC by subgroups | Estimate the risk of PDAC in the study population by racial and ethnic groups. | Baseline and approximately every six months for up to three years |
Reasons consent for intervention was declined | Evaluate the reasons invited participants decline consent for imaging intervention. | Baseline and approximately every six months for up to five years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
50 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.