A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus

Pancreatic Cancer Clinical Trial

— PANDOME  

Official title:

A PAncreatic Cancer Screening Study in Individuals With New-Onset or DeteriOrating Diabetes MEllitus (PANDOME Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03937453
• Other study ID #: 18-01
• Status: Recruiting
• Start date: January 19, 2018
• Est. completion date: January 19, 2028

Study information

• Verified date: March 2024
• Source: Nuvance Health
• Contact: Tammy Lo, APRN
• Phone: 203-855-3551
• Email: Tammy.Lo[@]nuvancehealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 19, 2028
• Est. primary completion date: January 19, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	Nuvance Health	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Nuvance Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Stage Pancreatic Cancer or Precursor Lesions	Determine incidence of pancreatic cancer or precursor lesions in individuals with new-onset diabetes mellitus or deteriorating diabetes	Through study completion, up to 3 years
Secondary	Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes	Assess utility of MRI as a screening tool for pancreatic cancer and ascertain relative risk of pancreatic cancer in study population of individuals with new-onset diabetes compared to a normal population of the same age	Through study completion, up to 3 years
Secondary	Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes	Assess utility of MRI as a screening tool for pancreatic cancer and ascertain relative risk of pancreatic cancer in study population of individuals with deteriorating diabetes compared to a normal population of the same age	Through study completion, up to 3 years

External Links

•   More information regarding the Pancreatic Cancer Screening Study may be found here