A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
NCT ID: NCT03937453
Last Updated: 2024-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2018-01-19
2028-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New-Onset Diabetes Mellitus
Diabetes Mellitus diagnosed within the past 12 months
MRI/MRCP
An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed at baseline. Further imaging upon recommendation by study committee
Deteriorating Diabetes Mellitus
History of Diabetes Mellitus with recent deteriorating within the past 6 months confirmed with repeat testing and not associated with weight gain or diabetes medication non-compliance
MRI/MRCP
An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed at baseline. Further imaging upon recommendation by study committee
Interventions
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MRI/MRCP
An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed at baseline. Further imaging upon recommendation by study committee
Eligibility Criteria
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Inclusion Criteria
* DM of Confirmed Duration: DM diagnosed within the past 12 months AND documentation of prior normal FPG, OGTT or HbA1c levels within the past 2 years. Requirement for HbA1c ≥ 6.5% OR
* DM of Unconfirmed Duration: DM diagnosed within the past 12 months BUT no prior record of normal FPG, HbA1c or OGTT within the past 2 years. Requirement for HbA1c ≥ 7.0% OR
* Transition from pre-Diabetes to Diabetes Mellitus within the past 12 months characterized by a change in the HbA1c of ≥ 0.5% OR
* DM With Only One FDR: DM diagnosed within the past 12 months that is of Confirmed or Unconfirmed Duration, in an individual with 1 FDR. Requirement for HbA1c ≥ 6.5%. OR
* Deteriorating Diabetes: DM with \>2% spike in HbA1c within past 6 months confirmed with repeat testing and NOT associated with weight gain and diabetes medication non-compliance
* ECOG Performance Status of 0-1.
* No known contraindications to MRI examination or gadolinium contrast.
* Willing to undergo MRI and screening for metal implants or metal injury.
* Recent BUN and Cr
* Estimated GFR (eGFR) must be greater than 30 mL/min.
* Ability to provide informed consent.
* Willing to return to study site for all study assessments.
Exclusion Criteria
* Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
* Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
* Hereditary pancreatitis.
* eGFR \< 30 mL/min.
* Contraindication to MRI examination or gadolinium contrast.
* Pregnant or nursing women.
* Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.
50 Years
ALL
Yes
Sponsors
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Nuvance Health
OTHER
Responsible Party
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Richard Frank
Director of Cancer Research
Principal Investigators
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Richard Frank, MD
Role: PRINCIPAL_INVESTIGATOR
Nuvance Health
Locations
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Nuvance Health
Norwalk, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18-01
Identifier Type: -
Identifier Source: org_study_id
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