Early Detection Initiative For Pancreatic Cancer

Study Overview

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.

Hyperglycemia
Diabetes Mellitus
Pancreas Ductal Adenocarcinoma

OTHER: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score
OTHER: Abdominal imaging

466
STU25020081 (OTHER Identifier) (OTHER: Univo Institutional Review Board)
ONC-15162 (OTHER Identifier) (OTHER: Contract Research Organization)

Study Record Dates

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
First Submitted 2020-11-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-04
First Submitted that Met QC Criteria 2020-12-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-08
First Posted (ACTUAL) 2020-12-10	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

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 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 electro 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 perfor
NO_INTERVENTION: Observation Arm (Site) Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.

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

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 electro

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 perfor

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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:

Patient must have given institutional consent for minimal risk studies.
Patient must be ≥50 and ≤85 years of age at the time of diagnosis [index date Parameters of Diabetes Mellitus (PDM)].
Patient must have index weight and left-window weight values available in electronic medical record (EMR).
Patient must have hyperglycemia and/or diabetes as one of the following (all glycemic parameters, except for HbA1c, must be measured in an outpatient setting):

Fasting Blood Glucose (FBG) ≥126 mg/dl
Glycated hemoglobin (HbA1c) ≥ 6.5%
Random Blood Glucose (RBG) ≥200 mg/dl
2 hour Post Glucose (PG) ≥ 200mg (11.1 mmol/L) during oral glucose tolerance test (OGTT)

Patient must have ≥1 glycemic parameter measured in the past 91-548 days prior to the index PDM date (Left Window) without meeting inclusion criteria A, B, or C.
For Intervention Sites, patients must meet inclusion criteria A, B, or C ≤90 days prior to enrollment.

Patient has declined institutional consent for minimal risk studies.
Patient must not have any known past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C

Patient must not be on ongoing active treatment for cancer, and/or carry a current diagnosis of any cancer (except non-melanoma skin cancer). Non-invasive cancer of any organ (carcinoma-in-situ/high grade dysplasia) is not an exclusion.

Patient must not have had a definitive diagnosis of pancreatic cancer prior to index PDM date.
Patient must not be on any anti-diabetes medications prior to index PDM date.
Patient must not be on chronic or acute use of steroid medications ≤90 days prior to the index PDM date.

Patient must not have had an intra-articular steroid injection ≤ 7 days prior to the index PDM date.
Patient must have values available in the EMR to calculate the ENDPAC score.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Suresh Chari, MD, M.D. Anderson Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Sharma A, Kandlakunta H, Nagpal SJS, Feng Z, Hoos W, Petersen GM, Chari ST. Model to Determine Risk of Pancreatic Cancer in Patients With New-Onset Diabetes. Gastroenterology. 2018 Sep;155(3):730-739.e3. doi: 10.1053/j.gastro.2018.05.023. Epub 2018 Jun 11.
Sharma A, Smyrk TC, Levy MJ, Topazian MA, Chari ST. Fasting Blood Glucose Levels Provide Estimate of Duration and Progression of Pancreatic Cancer Before Diagnosis. Gastroenterology. 2018 Aug;155(2):490-500.e2. doi: 10.1053/j.gastro.2018.04.025. Epub 2018 Apr 30.
Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007.
Khan S, Safarudin RF, Kupec JT. Validation of the ENDPAC model: Identifying new-onset diabetics at risk of pancreatic cancer. Pancreatology. 2021 Apr;21(3):550-555. doi: 10.1016/j.pan.2021.02.001. Epub 2021 Feb 8.
Chen W, Butler RK, Lustigova E, Chari ST, Wu BU. Validation of the Enriching New-Onset Diabetes for Pancreatic Cancer Model in a Diverse and Integrated Healthcare Setting. Dig Dis Sci. 2021 Jan;66(1):78-87. doi: 10.1007/s10620-020-06139-z. Epub 2020 Feb 28.
Chari ST, Maitra A, Matrisian LM, Shrader EE, Wu BU, Kambadakone A, Zhao YQ, Kenner B, Rinaudo JAS, Srivastava S, Huang Y, Feng Z; Early Detection Initiative Consortium. Early Detection Initiative: A randomized controlled trial of algorithm-based screening in patients with new onset hyperglycemia and diabetes for early detection of pancreatic ductal adenocarcinoma. Contemp Clin Trials. 2022 Feb;113:106659. doi: 10.1016/j.cct.2021.106659. Epub 2021 Dec 23.

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