Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients
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|ClinicalTrials.gov Identifier: NCT03048266|
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : February 8, 2018
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.
|Condition or disease|
|Multiple Endocrine Neoplasia|
|Study Type :||Observational|
|Estimated Enrollment :||629 participants|
|Official Title:||Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in Multiple Endocrine Neoplasia Type 1 Patients|
|Actual Study Start Date :||November 5, 2015|
|Estimated Primary Completion Date :||November 1, 2025|
|Estimated Study Completion Date :||November 1, 2026|
|MEN1 Patients Who Have Developed Aggressive PNETs-Cases|
|MEN1 Patients Who Have Developed Non-Aggressive PNETs-Controls|
- Relationship of Serum Global Metabolic Profiles with Subsequent Development of Aggressive PNET [ Time Frame: 10 years ]Review of samples from 50 cases (aggressive PNET) and 50 controls (non-aggressive PNET).
- Prediction of Occurrence of Aggressive PNET among MEN1 Patients by Examining Patterns of Serum Metabolic Biomarkers [ Time Frame: 10 years ]Advanced metabolomics technology used to demonstrate that various patterns of serum metabolic biomarkers can predict the occurrence of aggressive PNET among MEN1 patients.
- Prospectively Identify 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) [ Time Frame: 10 years ]The levels of miRNA in each group defined as mean ±SD. One-way ANOVA used to identify possible associations between miRNA concentrations and clinicopathological features of aggressive patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048266
|Contact: Nancy D. Perrier, MD||713-792-6940|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nancy D. Perrier, MD||M.D. Anderson Cancer Center|