Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients

Multiple Endocrine Neoplasia Clinical Trial

Official title:

Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in Multiple Endocrine Neoplasia Type 1 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048266
• Other study ID #: PA15-0822
• Status: Recruiting
• Start date: November 5, 2015
• Est. completion date: November 1, 2026

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: Nancy D. Perrier, MD
• Phone: 713-792-6940
• Email: NPerrier[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 629
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Multiple Endocrine Neoplasia
• Multiple Endocrine Neoplasia Type 1
• Neoplasms
• Neuroendocrine Tumors

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of Serum Global Metabolic Profiles with Subsequent Development of Aggressive PNET	Review of samples from 50 cases (aggressive PNET) and 50 controls (non-aggressive PNET).	10 years
Secondary	Prediction of Occurrence of Aggressive PNET among MEN1 Patients by Examining Patterns of Serum Metabolic Biomarkers	Advanced metabolomics technology used to demonstrate that various patterns of serum metabolic biomarkers can predict the occurrence of aggressive PNET among MEN1 patients.	10 years
Secondary	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)	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.	10 years

External Links

•   University of Texas MD Anderson Cancer Center Website