Clinical trial · Interventional
Early Detection Initiative for Pancreatic Cancer
A Prospective Study of Algorithm-based Screening in Patients With Glycemically Defined New Onset Diabetes to Evaluate Risk for and Earlier Detection of Pancreatic Ductal Adenocarcinoma; Early Detection Initiative (EDI) for Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus | — | UNRESOLVED | — |
| Hyperglycemia | — | UNRESOLVED | — |
| Pancreas Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal imaging | Other | — | UNRESOLVED |
| Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm (Site)
- description
- 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.
- interventionNames
- Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score
- Other: Abdominal imaging
- type
- NO_INTERVENTION
- label
- Observation Arm (Site)
- description
- Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.
Primary outcomes (2)
- measure
- Validate the ENDPAC model
- timeFrame
- Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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): A. Glycated hemoglobin (HbA1c) ≥ 6.5% OR B. Any (2) PDMs on consecutive (≤90 days between PDMs) or simultaneous testing: * 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) OR C. Any one (1) PDM present followed by an anti- diabetes medication ≤90 days after the index PDM date * 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. Exclusion Criteria: * 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 \*Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion. * 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. \*Ongoing work up for suspicion of pancreatic cancer 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. \*Allowed: Nasal, topical steroids, oral budesonide, ophthalmic * 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.
References
Publications (8)
- BACKGROUNDChari ST, Wu B, Lopez C, Lustigova E, Chen Q, Van Den Eeden SK, Leimpeter AD, Fisher W, Wood A, Alexander AS, Valenta J, Vege SS, Carlson EE, Rabe KG, Hart PA, Qian L, Zhao YQ, Yosuf N, Matrisian L, Kenner B, Rinaudo JA, Maitra A, Feng Z. Risk of Pancreatic Cancer in Glycemically Defined New-Onset Diabetes: A Prospective Cohort Study. Gastroenterology. 2026 Jan;170(1):106-117. doi: 10.1053/j.gastro.2025.06.025. Epub 2025 Jul 7. PMID 40633624
- BACKGROUNDSharma 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. PMID 29775599
- BACKGROUNDSharma 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. PMID 29723506
- BACKGROUNDChari 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. PMID 16083707
- BACKGROUNDKhan 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. PMID 33583686
- BACKGROUNDChen 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. PMID 32112260
- DERIVEDChari ST, Feng Z, Wu B, Fisher W, Kambadakone A, Zhao YQ, Maitra A, Kenner B, Matrisian LM. Heuriskance: a novel paradigm for systematic earlier detection of sporadic pancreatic cancer. J Natl Cancer Inst. 2026 Aug 1;118(8):1353-1363. doi: 10.1093/jnci/djaf291.