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

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00745381

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 we 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:	Cohort, 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:

MedlinePlus related topics: Cancer Pancreatic Cancer Stomach Cancer

U.S. FDA Resources

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

Biospecimen Description:

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.

Estimated Enrollment:	200
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (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 a family history questionnaire that captures information on cancer in the participant's first, second and third degree relatives will be completed. All participants will be invited to provide a DNA (blood sample) and tissue sample for the purposes of developing a tissue repository. If patients are having surgery, we will work through the tissue procurement service to ensure the fresh frozen tissue is properly collected and stored.

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 a family history questionnaire that captures information on cancer in the participant's first, second and third degree relatives will be completed. All participants will be invited to provide a DNA (blood sample) and tissue sample for the purposes of developing a tissue repository. If patients are having surgery, we will work through the tissue procurement service to ensure the fresh frozen tissue is properly collected and stored.

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

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

Contacts

Contact: Diane Reidy-Lagunes, MD		reidyd@mskcc.org
Contact: Laura Tang, MD		tangl@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Diane Reidy-Lagunes, MD reidyd@mskcc.org
Contact: Laura Tang, MD tangl@mskcc.org
Principal Investigator: Diane Reidy-Lagunes, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Diane Reidy-Lagunes, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Diane Reidy-Lagunes, MD )
Study ID Numbers:	08-105
Study First Received:	September 2, 2008
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00745381 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

PANCREAS
STOMACH
Questionnaire

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Neuroendocrine Tumors
Neuroectodermal Tumors
Digestive System Diseases
Stomach Diseases

Stomach Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Stomach Cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Neoplasms, Nerve Tissue
Endocrine System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms

Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Neoplasms, Germ Cell and Embryonal
Stomach Neoplasms
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009