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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00582647
Other study ID # 00-032
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2000
Est. completion date December 2024

Study information

Verified date January 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
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