NCT03937453 A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
| NCT ID | NCT03937453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nuvance Health |
| Condition | Pancreatic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2018-01-19 |
| Primary Completion | 2028-01-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2018-01-19 with a primary completion date of 2028-01-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. * 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.
Contact & Investigator
Richard Frank, MD
PRINCIPAL INVESTIGATOR
Nuvance Health
Frequently Asked Questions
Who can join the NCT03937453 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03937453 currently recruiting?
Yes, NCT03937453 is actively recruiting participants. Contact the research team at Tammy.Lo@nuvancehealth.org for enrollment information.
Where is the NCT03937453 trial being conducted?
This trial is being conducted at New Haven, United States, Norwalk, United States.
Who is sponsoring the NCT03937453 clinical trial?
NCT03937453 is sponsored by Nuvance Health. The principal investigator is Richard Frank, MD at Nuvance Health. The trial plans to enroll 800 participants.
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