Screening for pancreatic cancer in people with new or worsening diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the link between new-onset or deteriorating diabetes mellitus and the diagnosis of pancreatic cancer. Participants aged 50 and older will be recruited and undergo MRI and MRCP imaging to detect early-stage pancreatic cancer or precursor lesions. Additionally, blood samples will be collected every six months for three years to create a bio-bank for future blood-based screening tests. The study will also include psychological assessments to support participant well-being.

Why it matters

Who can join: the full rules

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.
* 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.
* Use of high dose glucocorticoid steroids (at least 20 mg daily of prednisone) within 3 months of diabetes diagnosis or elevation of HbA1c. Lower doses of steroid use as a cause of glucocorticoid-induced diabetes will be made on a case-by-case basis.
* 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.

Where it's running

• Nuvance Health
  Norwalk, Connecticut, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Not yet recruiting

Study contacts

• Principal investigator: Richard Frank, MD — Nuvance Health
• Study coordinator: Tammy Lo, MSN
• Email: Tammy.Lo@nuvancehealth.org
• Phone: 203-855-3551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.