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Completed

NCT Number: NCT02001337

Examination of the Pancreas in New-onset Diabetes

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

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Key information

Conditions

Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical chart review

Other

baseline, quarterly follow-up for 24 months

Survey Administration

Other

baseline

Specimen Collection

Other

baseline

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Examination of the Pancreas in New-onset Diabetes (EXPAND Study)

Acronym: EXPAND

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2013
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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