Evaluation for NCI Surgery Branch Clinical Research Protocols

Status Recruiting

Clinical Trial Summary

Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols. Eligibility: Patients 18 years or older must meet the minimum eligibility criteria for an NCI-SB treatment protocol. Design Patients will undergo testing and evaluations as required by the appropriate NCI-SB treatment protocol. ...

Clinical Trial Description

Background: Potential research candidates undergo thorough screening including laboratory tests, scans, x-rays, and review of pathology slides to determine initial eligibility for National Cancer Institute Surgery Branch (NCI-SB) research protocols. Objectives: Permit evaluation of patients referred to the NCI-SB in order to identify individuals who will be suitable candidates for NCI-SB clinical research protocols. To assess frequency of HLA type, gene specific mutations or expression of neo antigens in malignant tumors across the population of cancer patients undergoing screening for NCI-SB protocols. Collect results of screening tests for use on subsequent research protocol as baseline (e.g., pretreatment) values. Eligibility: Age >= 18 years. Patient suspected of having, or with biopsy proven, malignant disease. Patient is able to understand and willing to sign a written informed consent document. Patient is being evaluated for treatment on an NCI-SB protocols.. Design: Patients enrolled on this protocol will be evaluated by NCI-SB physicians to determine the individual's suitability for participation in a clinical research protocol. An accrual ceiling of 7,000 patients has been set to meet the screening needs of the NCI-SB. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00001823
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact	NCI SB Immunotherapy Recruitment Center
Phone	(866) 820-4505
Email	irc@nih.gov
Status	Recruiting
Phase
Start date	July 11, 1999

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.