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Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Multiple Endocrine Neoplasia

Study type

Observational

Funder types

Other

Identifiers

NCT03048266
PA15-0822

Details and patient eligibility

About

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.

Enrollment

629 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

629 participants in 2 patient groups

MEN1 Patients Who Have Developed Aggressive PNETs-Cases
MEN1 Patients Who Have Developed Non-Aggressive PNETs-Controls

Trial contacts and locations

1

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Central trial contact

Nancy D. Perrier, MD

Data sourced from clinicaltrials.gov

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