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Trial record 4 of 12 for:    "Multiple endocrine neoplasia type 1"

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
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease
Multiple Endocrine Neoplasia

Study Type : Observational
Estimated Enrollment : 629 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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


Group/Cohort
MEN1 Patients Who Have Developed Aggressive PNETs-Cases
MEN1 Patients Who Have Developed Non-Aggressive PNETs-Controls



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  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) [ 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

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:


Information from the National Library of Medicine

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


Contacts
Contact: Nancy D. Perrier, MD 713-792-6940

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Nancy D. Perrier, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03048266     History of Changes
Other Study ID Numbers: PA15-0822
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Multiple endocrine neoplasia
MEN1
Aggressive pancreatic neuroendocrine tumors
PNET
Non-aggressive pancreatic neuroendocrine tumors
Metabolomics
Genetics
Biomarkers

Additional relevant MeSH terms:
Multiple Endocrine Neoplasia Type 1
Neoplasms
Neuroendocrine Tumors
Adenoma, Islet Cell
Multiple Endocrine Neoplasia
Endocrine Gland Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn