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Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients

NCT03048266 · M.D. Anderson Cancer Center
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Official title
Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in Multiple Endocrine Neoplasia Type 1 Patients
About this study
Objectives: The aim of the present study is to assess the significance of metabolomics and genetics in diagnosing and survival evaluation for pNET in the periodic follow-up of MEN1 patients. Aim 1: To evaluate the relationship of serum global metabolic profiles with subsequent development of aggressive PNET and evaluate patients survival in a nested case-control study of MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have developed non-aggressive PNETs (controls). Aim 2: Validate the top serum metabolites identified from Aim 1 in MEN1 patients who have developed aggressive PNETs and MEN1 patients who have developed non-aggressive PNETs, using a targeted metabolomics approach. Aim 3: Prospectively identify the potential miRNA biomarkers of serum with miRNA sequencing in MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have developed non-aggressive PNETs (controls). Aim 4: Validate the potential miRNA biomarkers identified from Aim 1 in MEN1 patients who have developed aggressive PNETs and in MEN1 patients who have developed non-aggressive PNETs, using a targeted qRT-PCR approach (in serums), as well as to see the relationship of potential miRNA biomarkers with patients survival.
Eligibility criteria
Inclusion Criteria: 1. The study will include all patients with a confirmed MEN1 diagnosis (clinical, genetic or familial criteria). 2. No prior history of PNET. Exclusion Criteria: N/A
Study design
Enrollment target: 629 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2015-11-05
Estimated completion: 2026-11-01
Last updated: 2019-05-23
Primary outcomes
  • Relationship of Serum Global Metabolic Profiles with Subsequent Development of Aggressive PNET (10 years)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactNancy D. Perrier, MD · contact · NPerrier@mdanderson.org · 713-792-6940
InvestigatorNancy D. Perrier, MD · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients · TrialPath