Early Detection Initiative for Pancreatic Cancer
- Conditions
- HyperglycemiaDiabetes MellitusPancreas Ductal Adenocarcinoma
- Interventions
- Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) scoreOther: Abdominal imaging
- Registration Number
- NCT04662879
- Lead Sponsor
- Pancreatic Cancer Action Network
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 9000
- 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.
-
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.
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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
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Patient must not have had an intra-articular steroid injection ≤ 7 days prior to the index PDM date.
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Patient must have values available in the EMR to calculate the ENDPAC score.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm (Site) Abdominal imaging 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. Intervention Arm (Site) Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score 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.
- Primary Outcome Measures
Name Time Method Validate the ENDPAC model Baseline and approximately every six months for up to three years Prospectively validate the ENDPAC model.
Quantify potentially clinically meaningful lead time for earlier detection of PDAC Baseline and approximately every six months for up to three years Measure the duration from G-NOD to date of clinical diagnosis of PDAC.
- Secondary Outcome Measures
Name Time Method Evaluate the risk of PDAC in G-NOD Baseline and approximately every six months for up to three years Estimate the risk of PDAC in G-NOD in the average risk population including potentially clinically meaningful lead time for earlier detection of PDAC.
Proportion of incidental findings on imaging Baseline and imaging follow-up visit, up to 9 months Evaluate, on imaging at the time of G-NOD, the proportion with incidental findings including those that require clinical work-up.
Reasons consent for intervention was declined Baseline and approximately every six months for up to five years Evaluate the reasons invited participants decline consent for imaging intervention.
Risk of PDAC by subgroups Baseline and approximately every six months for up to three years Estimate the risk of PDAC in the study population by racial and ethnic groups.
Trial Locations
- Locations (2)
Kaiser Permanente Southern California, Kaiser Permanente Research
🇺🇸Pasadena, California, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States