Early Detection Initiative for Pancreatic Cancer (EDI)

  • STATUS
    Recruiting
  • End date
    Jul 27, 2030
  • participants needed
    12500
  • sponsor
    Pancreatic Cancer Action Network
Updated on 27 April 2022
cancer
fasting
oral glucose tolerance test
fasting blood glucose
hyperglycemia
hemoglobin a1c
glucose tolerance test

Summary

The Early Detection Initiative for Pancreatic Cancer is a multi-center randomized controlled trial to determine if algorithm-based screening in patients with new onset hyperglycemia and diabetes can result in earlier detection of pancreatic ductal adenocarcinoma.

Description

The Early Detection Initiative (EDI), is designed to evaluate if imaging at the time of new onset hyperglycemia and diabetes, especially at its earliest discovery through passive surveillance of the electronic medical record (EMR), results in earlier detection of pancreatic ductal adenocarcinoma (PDAC).

Eligible patients are identified and enrolled based on a first-time elevation in fasting blood glucose or glycated hemoglobin (HbA1c) to the level indicating diabetes as derived from records in their EMR. All enrolled patients are randomized to either the Observational Arm or Intervention Arm of the study. Patients randomized to the Intervention Arm have 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 study questionnaires and participate in serial blood collection at up to five time points. Blood samples collected in the EDI study will contribute to the National Institutes of Health (NIH) National Cancer Institute (NCI) biorepository located at the Frederick National Laboratory for Cancer Research facility. Patients in both study arms 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 five years following enrollment. Any patient that has declined participation in EMR-based research at the institution is not included in the study.

Details
Condition Hyperglycemia, Diabetes Mellitus, Pancreas Ductal Adenocarcinoma
Treatment Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score, Abdominal imaging, Abdominal imaging
Clinical Study IdentifierNCT04662879
SponsorPancreatic Cancer Action Network
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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 ≤90 days prior to randomization (all glycemic parameters, except for HbA1c, must be measured in an outpatient setting)
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
OR
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
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

Exclusion Criteria

Patient has declined institutional consent for minimal risk studies
Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion
Patient must not have any known past history of hyperglycemia and/or diabetes as
defined by inclusion criteria A, B, or C
Ongoing work up for suspicion of pancreatic cancer is not an exclusion
Patient must not be on active treatment for cancer, carry a current diagnosis of any
Patient must not be on any anti-diabetes medications prior to index PDM date
cancer, and/or investigated for suspicion of recurrence of past cancer (except
Allowed: Nasal, topical steroids, oral budesonide, ophthalmic
non-melanoma skin cancer or carcinoma in-situ of the cervix)
Patient must not have had a definitive diagnosis of pancreatic cancer 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
Patient must not have had an intra-articular steroid injection ≤ 7 days prior to the
index PDM date
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