Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The study will include all patients with a confirmed MEN1 diagnosis (clinical, genetic or familial criteria).

No prior history of PNET.

Disqualifiers

None

Trial population

Study subjects identified from a cohort of MEN1 patients. These patients had previously consented to collection of clinical data, blood, and parathyroid tissue for research purposes at MD Anderson Cancer Center.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

629 Participants
are grouped into 2 trial groups
Group A: MEN1 Patients Who Have Developed Aggressive PNETs-Cases
Group B: MEN1 Patients Who Have Developed Non-Aggressive PNETs-Controls

Trial outcomes

Primary outcomes

1

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).

Time frame
10 years

Secondary outcomes

1

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.

Time frame
10 years
2

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.

Time frame
10 years

Other outcomes

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