Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients
NCT ID: NCT03048266
Last Updated: 2019-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
629 participants
OBSERVATIONAL
2015-11-05
2026-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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MEN1 Patients Who Have Developed Aggressive PNETs-Cases
No interventions assigned to this group
MEN1 Patients Who Have Developed Non-Aggressive PNETs-Controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. No prior history of PNET.
Exclusion Criteria
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nancy D. Perrier, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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PA15-0822
Identifier Type: -
Identifier Source: org_study_id
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