Recruiting

Pancreatic Tumors

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03048266

Conditions

Multiple Endocrine Neoplasia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Multiple Endocrine Neoplasia

Study ID

NCT03048266

Start date

Nov 5, 2015

Status verified date

May, 2019

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

629 participants

Anticipated

Interventions and Outcome Measures

Arms

MEN1 Patients Who Have Developed Aggressive PNETs-Cases

MEN1 Patients Who Have Developed Non-Aggressive PNETs-Controls

Primary outcome measure

  • Relationship of Serum Global Metabolic Profiles with Subsequent Development of Aggressive PNET [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Nancy D. Perrier, MD

713-792-6940NPerrier@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 23, 2019

Last verified

May, 2019

Keywords

  • Multiple endocrine neoplasia
  • MEN1
  • Aggressive pancreatic neuroendocrine tumors
  • PNET
  • Non-aggressive pancreatic neuroendocrine tumors
  • Metabolomics
  • Genetics
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2019-05-23.