- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001337
Examination of the Pancreas in New-onset Diabetes (EXPAND)
November 5, 2019 updated by: Gloria M. Petersen, Mayo Clinic
Examination of the Pancreas in New-onset Diabetes (EXPAND Study)
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
79
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Suspected or definite new-onset diabetes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and identify pancreatic cancer in this cohort.
Time Frame: Follow subjects for 2 years.
|
We will prospectively identify patients with newly diagnosed diabetes and perform pancreatic imaging to identify pancreatic cancer
|
Follow subjects for 2 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gloria Petersen, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
November 30, 2016
Study Completion (Actual)
November 30, 2016
Study Registration Dates
First Submitted
November 22, 2013
First Submitted That Met QC Criteria
November 27, 2013
First Posted (Estimate)
December 4, 2013
Study Record Updates
Last Update Posted (Actual)
November 7, 2019
Last Update Submitted That Met QC Criteria
November 5, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-006868
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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