Clinical trial NCT03937453: A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
Official title: A PAncreatic Cancer Screening Study in Individuals With New-Onset or DeteriOrating Diabetes MEllitus (PANDOME Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Pancreatic Neoplasms
Keywords: Pancreas
Cancer
Diabetes Mellitus
MRI
Early Detection
Lead sponsor: Nuvance Health
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50+ years of age. New-onset diabetes mellitus (diagnosed with within the preceding 12 months) or Deteriorating diabetes mellitus (spike in HbA1c within past 6 months without weight gain and medication non-compliance)

Brief summary: The main goal of this study is to explore the relationship between new-onset diabetes mellitus/deteriorating diabetes and a subsequent diagnosis of pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for pancreatic cancer.

Detailed description: Individuals over 50 years of age who have developed new-onset diabetes mellitus (diagnosed within the past 12 months) or deteriorating diabetes will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed at baseline. Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. Additional MRI will be performed on case-by-case basis

Eligibility criteria: Inclusion Criteria:

* Age of at least 50 years.
* 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:

* Prior history of pancreatic cancer.
* 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.

Primary outcomes:
measure: Early Stage Pancreatic Cancer or Precursor Lesions
timeFrame: Through study completion, up to 3 years
Secondary outcomes:
measure: Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes
timeFrame: Through study completion, up to 3 years
measure: Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes
timeFrame: Through study completion, up to 3 years
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Nuvance Health
state: Connecticut
Study officials:
affiliation: Nuvance Health
name: Richard Frank, MD
role: PRINCIPAL_INVESTIGATOR
References: