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

NCT00745381 | Completed

• 1 other identifier: 08-105
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Gastric Cancer; Pancreatic Cancer

Keywords

PANCREAS; STOMACH; Questionnaire; 08-105

Outcome Measures

Primary Outcomes (1)

• 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.

  conclusion of the study

Study Arms (1)

1

This registry will be open to all patients with GEPNET or NET of unknown primary.

Other: questionnaire, Blood specimens

Interventions

questionnaire, Blood specimens OTHER

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with GEPNET or NET of unknown primary

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan-Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

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.

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Diane Reidy-Lagunes, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: August 1, 2008
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Locations

US (3)