Diabetes Mellitus, Hyperglycemia, Pancreas Ductal Adenocarcinoma
Conditions
Keywords
New Onset Diabetes, Hyperglycemia, Diabetes Mellitus, Pancreatic Ductal Adenocarcinoma, ENDPAC score, Weight loss, Glycemically defined new onset diabetes
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 if 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 a minimum of three years following enrollment, until the planned study cutoff date January 31, 2028. Any patient that has declined participation in EMR-based research at the institution is not included in the study.
Interventions
OTHEREnriching 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.
OTHERAbdominal 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.
Sponsors
Pancreatic Cancer Action Network
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Post-enrollment consent
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validate the ENDPAC model | Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028 | Prospectively validate the ENDPAC model. |
| Quantify potentially clinically meaningful lead time for earlier detection of PDAC | Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028 | Measure the duration from G-NOD to date of clinical diagnosis of PDAC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the risk of PDAC in G-NOD | Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028 | 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. |
| Risk of PDAC by subgroups | Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028 | Estimate the risk of PDAC in the study population by racial and ethnic groups. |
| Reasons consent for intervention was declined | Baseline and imaging follow-up visit, up to 9 months | Evaluate the reasons invited participants decline consent for imaging intervention. |
Countries
United States
Contacts
STUDY_CHAIRSuresh Chari, MD
M.D. Anderson Cancer Center
PRINCIPAL_INVESTIGATORAnirban Maitra, MBBS
Perlmutter Cancer Center at NYU Langone Health
PRINCIPAL_INVESTIGATORBechien Wu, MD
Kaiser Permanente
PRINCIPAL_INVESTIGATORAvinash Kambadakone-Ramesh, MD, FRCR
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORZiding Feng, PhD
Fred Hutchinson Cancer Center
PRINCIPAL_INVESTIGATORWilliam Fisher, MD
Baylor College of Medicine
Outcome results
None listed