Early Detection Initiative for Pancreatic Cancer (EDI)

Pancreatic Cancer Action Network

Status: Active, not recruiting

Conditions: Hyperglycemia; Diabetes Mellitus; Pancreas Ductal Adenocarcinoma

Treatments: Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score; Other: Abdominal imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04662879

466

ONC-15162 (Other Identifier)

STU25020081 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,869 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8,869 participants in 2 patient groups

Intervention Arm (Site)

Experimental group

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.

Treatment:

Other: Abdominal imaging

Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score

Observation Arm (Site)

No Intervention group

Description:

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