A Collection of Clinical and Epidemiologic Data Combined With Tissue and Blood From Patients With a Diagnosis of Neuroendocrine Tumors

July 31, 2020 updated by: Memorial Sloan Kettering Cancer Center

Gastroenteropancreatic and Unknown Primary Neuroendocrine Registry A Collection of Clinical and Epidemiologic Data Combined With Tissue and Blood From Patients With a Diagnosis of Neuroendocrine Tumors

The purpose of this study is to establish a neuroendocrine tumor registry. A registry is a collection of information. To create this registry, the investigators would like to get information, blood and tumor samples from people with neuroendocrine tumors. By collecting this information and material, the investigators are hoping to learn more about the genetic causes of neuroendocrine tumors. All of this will help us to better understand neuroendocrine cancer, so the investigators can find better ways to treat and diagnose this disease. DNA will be taken from the blood samples and will be used in future studies. This will be an important resource from which the investigators can study genes that may be related to a higher risk of neuroendocrine tumors.

The information collected will include medical information, family history of cancer and your answers to questions about how the cancer affects quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

238

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan-Kettering Cancer Center at Basking Ridge
    • New York
      • Commack, New York, United States
        • Memorial Sloan-Kettering Cancer Center at Commack
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with GEPNET or NET of unknown primary

Description

Inclusion Criteria:

  • Diagnosis of gastroenteropancreatic neuroendocrine tumors or neuroendocrine tumors of unknown primary
  • Willing to donate blood samples
  • >= 18years old
  • Patients may have received prior hormonal therapy, cytotoxic therapy, irradiation, immunotherapy or surgical therapy

Exclusion Criteria:

  • Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
This registry will be open to all patients with GEPNET or NET of unknown primary.
Other: questionnaire, Blood specimens
All participants will complete an epidemiology study questionnaire as well as a quality of life questionnaire. They will also be asked to donate blood samples. We will request participation in a tissue repository consisting of fresh frozen or paraffin embedded tissue. The repository will be of serum, plasma and tumor tissue. Follow-up will occur on patients every 6 months for the first year after consent and then annually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To develop a tissue, serum, plasma and DNA bank from individuals with NET. This bank will be combined with epidemiologic and clinical information to create a NET database.
Time Frame: conclusion of the study
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Diane Reidy-Lagunes, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

July 30, 2020

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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