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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|