Evaluation for NCI Surgery Branch Clinical Research Protocols
- Conditions
- Synovial Cell CancerColorectal CancerBladder CancerMelanomaLung Cancer
- Registration Number
- NCT00001823
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of HLA type, gene specific mutations, or expression of neoantigens in malignant tumors 25 years Frequency of HLA type, gene specific mutations, or expression of neoantigens in tissue and blood samples
Results of screening tests 25 years Results of screening tests for use on subsequent research protocol as baseline (e.g., pretreatment) values
Number of individuals suitable for NCI Surgery Branch clinical research protocols 25 Years Total number of patients who enroll on NCI Surgery Branch clinical research protocols
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States