NCT03048266 Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients
| NCT ID | NCT03048266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Multiple Endocrine Neoplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 629 participants |
| Start Date | 2015-11-05 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 629 participants in total. It began in 2015-11-05 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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: N/A
Contact & Investigator
Nancy D. Perrier, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT03048266 clinical trial?
This trial is open to participants of all sexes, studying Multiple Endocrine Neoplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03048266 currently recruiting?
Yes, NCT03048266 is actively recruiting participants. Contact the research team at NPerrier@mdanderson.org for enrollment information.
Where is the NCT03048266 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT03048266 clinical trial?
NCT03048266 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Nancy D. Perrier, MD at M.D. Anderson Cancer Center. The trial plans to enroll 629 participants.