Collection of Tissue & Blood From Patients w/ Benign & Malignant Tumors of the Soft Tissue & Gastrointestinal Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00582647
Recruitment Status : Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : September 8, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
Doctors at Memorial Sloan Kettering Cancer Center and at other institutions study normal and cancer cells. To study these cells we need to have human tissue, body fluids, and blood. The patient will be having or have had a procedure to remove tissue. The doctors would like to use some of this tissue. The doctors will use it for laboratory studies on the causes, prevention, diagnosis and treatment of sarcoma, gastrointestinal or other intra-abdominal cancers. They will only use extra tissue left over after all needed testing has been done. They would also like to study components of the immune blood cells and blood serum (the liquid portion of the blood). In some patients they will take a blood sample before the tissue or body fluid is removed, usually at the same time that other routine pre-procedure blood tests are drawn. If thet need more blood, it will be drawn when the patient is seeing the doctor anyway. We will not draw more than 50cc (4-5 tablespoons) at any one time. With the patient's permission, thet may also send a small portion of the blood and/or a sample of the tissue to a repository at the National Cancer Institute. This will be used to identify special proteins in the blood or tissue that may be useful for diagnosing cancer. Information about the treatment and the response to treatment may be linked to the tissue specimens obtained. This information may be important for the research studies that will be done on the tissue, body fluid and blood specimens. All of this information will be kept in strictest confidence; they will use it only for biomedical research. The patient's name will not be used in any report.

Condition or disease
Esophageal Cancer Bile Duct Neoplasms Gastric Cancer Liver Cancer Melanoma Pancreatic Cancer Sarcoma

Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Tissue, Blood and Other Specimens From Patients With Benign and Malignant Tumors of the Soft Tissue, Gastrointestinal Tract, and Other Intra-abdominal Sites.
Study Start Date : March 2000
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Primary Outcome Measures :
  1. To obtain & store tissues, blood, peritoneal, pleural, cyst & other gastrointestinal fluid from patients with benign or malignant tumors in order to carry out future laboratory studies on the causes, prevention, diagnosis & treatment of certain cancers. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Tissue, Blood, Peritoneal, Pleural, Cyst, and Other gastrointestinal fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

Inclusion Criteria:

For patients:

  • All patients with benign or malignant tumors of the soft tissues, gastrointestinal tract, and other intra-abdominal sites who will have or have had tissue, peritoneal, pleural, cyst, urine, and/or other gastrointestinal fluid removed for therapeutic or diagnostic purposes.
  • Patients will be entered without preference for any particular racial/ethnic group.
  • Patients may have received prior hormonal therapy, cytotoxic chemotherapy, irradiation, immunotherapy or surgical therapy.
  • Tissue and body fluid specimens must be a large enough quantity to allow routine pathological analysis, with the research laboratory specimen removed from the residual specimen which would otherwise be discarded.

Healthy Control Subjects:

  • Any male or female with no concurrent malignancies (except for localized basal cell or squamous cell skin cancer) within 5 years of enrollment.
  • > or = to 18 years of age
  • Any MSKCC employee will be allowed to participate as a healthy control, provided they fulfill the above inclusion criteria and they enroll willfully and voluntarily

Exclusion Criteria:

Healthy Control Subjects:

  • Attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g. mentally impaired) reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00582647

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Peter Allen, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00582647     History of Changes
Other Study ID Numbers: 00-032
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Bile Duct Neoplasms
Soft Tissue Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Liver Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type