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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00745381
First received: September 2, 2008
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Gastric Cancer
Pancreatic Cancer
Other: questionnaire, Blood specimens

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

All participants will be invited to provide a DNA (blood sample) and tissue sample for the purposes of developing a tissue repository. Blood samples will be collected. Expected accrual is 150 patients per year. Patients who donate blood and/or tissue samples are considered evaluable for protocol; however, it is preferred that both are obtained.


Estimated Enrollment: 300
Study Start Date: August 2008
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with GEPNET or NET of unknown primary

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745381

Locations
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Diane Reidy-Lagunes, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00745381     History of Changes
Other Study ID Numbers: 08-105
Study First Received: September 2, 2008
Last Updated: August 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
PANCREAS
STOMACH
Questionnaire
08-105

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Neuroendocrine Tumors
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on September 22, 2014