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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02001337
Other study ID # 10-006868
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2013
Est. completion date November 30, 2016

Study information

Verified date November 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer


Description:

Compared to the general population, subjects >50 years of age with new-onset diabetes (DM) are 8-times more likely to have pancreatic cancer (PaC). The likelihood of PaC in new-onset DM is further increased in those who have weight loss or elevated CA19-9. In this study patients with newly diagnosed diabetes will be prospectively identified. Those with weight loss and/or elevated pancreatic cancer marker (CA 19-9) will undergo pancreatic imaging. All subjects will be followed up to 24 months. If successful in identifying surgically removable PaC, this study will fundamentally change our practice and will be a major breakthrough in PaC treatment and research.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date November 30, 2016
Est. primary completion date November 30, 2016
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility Patient Characteristics:

--Suspected or definite new-onset diabetes based on recent blood sugar and hemoglobin A1c values

- No acute illness or steroid therapy

- No prior pancreas surgery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
medical chart review
baseline, quarterly follow-up for 24 months
survey administration
baseline
Specimen collection
baseline

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and identify pancreatic cancer in this cohort. We will prospectively identify patients with newly diagnosed diabetes and perform pancreatic imaging to identify pancreatic cancer Follow subjects for 2 years.
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