Collection of Tissue & Blood From Patients w/ Benign & Malignant Tumors of the Soft Tissue & Gastrointestinal Tract
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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. |
- 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 2014 |
| Estimated Primary Completion Date: | December 2014 (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 |
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.
Contacts and Locations| Contact: Peter Allen, MD | 212-639-5132 | |
| Contact: Peter Kingham, MD | 212-639-5260 |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| 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: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Bile Duct Neoplasms Neoplasms Esophageal Diseases Esophageal Neoplasms Liver Neoplasms Stomach Neoplasms Melanoma Pancreatic Neoplasms Soft Tissue Neoplasms Sarcoma Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site Bile Duct Diseases Biliary Tract Diseases |
Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Liver Diseases Stomach Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013