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Early Detection Initiative for Pancreatic Cancer (EDI)

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ClinicalTrials.gov Identifier: NCT04662879
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : November 1, 2021
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Pancreatic Cancer Action Network

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Diabetes Mellitus Pancreas Ductal Adenocarcinoma Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score Other: Abdominal imaging Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with post-randomization consent
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: A Randomized Controlled Trial of Algorithm-based Screening in Patients With New Onset Hyperglycemia and Diabetes for Early Detection of Pancreatic Ductal Adenocarcinoma (Early Detection Initiative (EDI) for Pancreatic Cancer)
Actual Study Start Date : October 14, 2021
Estimated Primary Completion Date : July 2030
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm

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.
Other: 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.

Other: 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.

No Intervention: Observation Arm
Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.



Primary Outcome Measures :
  1. Earlier detection of pancreatic ductal adenocarcinoma (PDAC) [ Time Frame: Baseline and approximately every six months for up to five years ]
    Determine if algorithm-based screening in new onset hyperglycemia and diabetes (NOD) results in earlier detection of pancreatic ductal adenocarcinoma (PDAC) as evidenced by a lower proportion of Stage III/IV disease at the time of PDAC diagnosis in intervention vs observation arm.


Secondary Outcome Measures :
  1. Smaller proportion of unresectable disease [ Time Frame: Baseline and approximately every six months for up to five years ]
    Determine if Intervention results in earlier detection of PDAC defined as a smaller proportion of unresectable disease.

  2. Less Stage IV disease [ Time Frame: Baseline and approximately every six months for up to five years ]
    Determine if Intervention results in earlier detection of PDAC defined as less Stage IV disease.

  3. Smaller proportion with advanced pancreatic cancer symptoms [ Time Frame: Baseline and approximately every six months for up to five years ]
    Determine if Intervention results in earlier detection of PDAC defined as a smaller proportion with advanced pancreatic cancer symptoms.

  4. Estimating risk in subgroups [ Time Frame: Baseline and approximately every six months for up to five years ]
    Estimate the risk of PDAC in NOD and Enriching New-onset Diabetes (or hyperglycemia) for Pancreatic Cancer (ENDPAC) subgroups.

  5. Validate ENDPAC model [ Time Frame: Baseline and approximately every six months for up to five years ]
    Prospectively validate the ENDPAC model.

  6. Over diagnosis due to imaging intervention of NOD [ Time Frame: Baseline and imaging follow-up visit, up to 9 months ]
    Determine the magnitude of over diagnosis due to imaging intervention of NOD.

  7. Determine the proportion of incidental findings [ Time Frame: Baseline and approximately every six months for up to five years ]
    Determine, on imaging in NOD, the proportion with incidental findings that require clinical workup.

  8. Contribute to NOD biobank [ Time Frame: Baseline and blood collection follow-up visits, up to 36 months ]
    Contribute blood biospecimens to a previously established NOD cohort biobank for future biomarker validation studies.

  9. Depression and Anxiety as early indicators [ Time Frame: Baseline and follow-up visits ]
    Determine if symptoms of depression and anxiety are early indicators of PDAC.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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):

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.

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 active treatment for cancer, carry a current diagnosis of any cancer, and/or investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

    *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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662879


Contacts
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Contact: Omer Mushtaq 206-667-2808 omushtaq@fredhutch.org
Contact: Jackie Dahlgren (206) 667-4170 jdahlgre@fredhutch.org

Locations
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United States, California
Kaiser Permanente Southern California, Kaiser Permanente Research Recruiting
Pasadena, California, United States, 91101
Contact: Soon Kyu Choi, MPP, MSc    888-203-5401    EDI@kp.org   
Principal Investigator: Bechien Wu, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Amy Wood, MPH    713-798-8960    pancreas@bcm.edu; amy.wood@bcm.edu   
Principal Investigator: William Fisher, MD         
Sponsors and Collaborators
Pancreatic Cancer Action Network
Fred Hutchinson Cancer Research Center
National Institutes of Health (NIH)
Investigators
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Study Chair: Suresh Chari, MD M.D. Anderson Cancer Center
Principal Investigator: Anirban Maitra, MBBS M.D. Anderson Cancer Center
Principal Investigator: Bechien Wu, MD Kaiser Permanente
Principal Investigator: Avinash Kambadakone-Ramesh, MD, FRCR Massachusetts General Hospital
Principal Investigator: Ziding Feng, PhD Fred Hutchinson Cancer Research Center
Additional Information:
Publications:
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Responsible Party: Pancreatic Cancer Action Network
ClinicalTrials.gov Identifier: NCT04662879    
Other Study ID Numbers: 466
10533 ( Other Identifier: Fred Hutchinson Institutional Review Board )
RG1007916 ( Other Identifier: Fred Hutchinson Cancer Research Center )
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pancreatic Cancer Action Network:
New Onset Diabetes
Hyperglycemia
Diabetes Mellitus
Pancreatic Ductal Adenocarcinoma
ENDPAC score
Weight loss
Additional relevant MeSH terms:
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Adenocarcinoma
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms