Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
8869 participants
INTERVENTIONAL
2021-10-14
2028-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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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.
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.
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.
Observation Arm (Site)
Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
\*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.
Exclusion Criteria
50 Years
85 Years
ALL
No
Sponsors
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Pancreatic Cancer Action Network
OTHER
Responsible Party
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Principal Investigators
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Suresh Chari, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Anirban Maitra, MBBS
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Bechien Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Avinash Kambadakone-Ramesh, MD, FRCR
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Ziding Feng, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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Kaiser Permanente Southern California, Kaiser Permanente Research
Pasadena, California, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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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.
Related Links
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Pancreatic Cancer Action Network Early Detection Initiative
Other Identifiers
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STU25020081
Identifier Type: OTHER
Identifier Source: secondary_id
ONC-15162
Identifier Type: OTHER
Identifier Source: secondary_id
466
Identifier Type: -
Identifier Source: org_study_id
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