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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582647
First received: December 21, 2007
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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
Esophageal Cancer
Bile Duct Neoplasms
Gastric Cancer
Liver Cancer
Melanoma
Pancreatic Cancer
Sarcoma

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


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

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

Biospecimen Retention:   Samples With DNA

Tissue, Blood, Peritoneal, Pleural, Cyst, and Other gastrointestinal fluid


Estimated Enrollment: 6000
Study Start Date: March 2000
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

Criteria

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.
  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: NCT00582647

Contacts
Contact: Peter Allen, MD 212-639-5132
Contact: Peter Kingham, MD 212-639-5260

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Peter Allen, MD    212-639-5132      
Principal Investigator: Peter Allen, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Peter Allen, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582647     History of Changes
Other Study ID Numbers: 00-032
Study First Received: December 21, 2007
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014