NCT04662879

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,869

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Oct 2021Jan 2028

First Submitted

Initial submission to the registry

November 20, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

October 14, 2021

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 12, 2026

Status Verified

June 1, 2025

Enrollment Period

6.2 years

First QC Date

November 20, 2020

Last Update Submit

March 10, 2026

Conditions

HyperglycemiaDiabetes MellitusPancreas Ductal Adenocarcinoma

Keywords

New Onset DiabetesHyperglycemiaDiabetes MellitusPancreatic Ductal AdenocarcinomaENDPAC scoreWeight lossGlycemically defined new onset diabetes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Evaluate the risk of PDAC in G-NOD

    Baseline and approximately every six months for up to three years

  • Proportion of incidental findings on imaging

    Baseline and imaging follow-up visit, up to 9 months

  • Risk of PDAC by subgroups

    Baseline and approximately every six months for up to three years

  • Reasons consent for intervention was declined

    Baseline and approximately every six months for up to five years

Other Outcomes (4)

  • Stage of disease at PDAC diagnosis

    Baseline and approximately every six months for up to three years

  • Glycemic parameters for ENDPAC model

    Baseline and approximately every six months for up to three years

  • ENDPAC model by subgroups

    Baseline and approximately every six months for up to three years

  • +1 more other outcomes

Study Arms (2)

Intervention Arm (Site)

EXPERIMENTAL

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) scoreOther: Abdominal imaging

Observation Arm (Site)

NO INTERVENTION

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

Interventions

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

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.

Intervention Arm (Site)
Abdominal imagingOTHER

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.

Intervention Arm (Site)

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%
  • 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
  • hour Post Glucose (PG) ≥ 200mg (11.1 mmol/L) during oral glucose tolerance test (OGTT)
  • C. Any one (1) PDM present followed by an anti- diabetes medication ≤90 days after the index PDM date

You may not qualify if:

  • Patient has declined institutional consent for minimal risk studies.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente Southern California, Kaiser Permanente Research

Pasadena, California, 91101, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (7)

  • Chari 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

    BACKGROUND

  • 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.

    PMID: 29775599BACKGROUND

  • 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.

    PMID: 29723506BACKGROUND

  • 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.

    PMID: 16083707BACKGROUND

  • 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.

    PMID: 33583686BACKGROUND

  • 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.

    PMID: 32112260BACKGROUND

  • 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.

    PMID: 34954100DERIVED

Related Links

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suresh Chari, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Post-enrollment consent
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

December 10, 2020

Study Start

October 14, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

March 12, 2026

Record last verified: 2025-06

Locations

US(2)