Bladder Cancer, Colorectal Cancer, Lung Cancer, Melanoma, Synovial Cell Cancer
Conditions
Keywords
Cancer, Gene Therapy, Immunotherapy, Clinical Trial
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.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: 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.
Exclusion criteria
Women of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of some of the screening procedures (e.g., nuclear medicine or other imaging scans) on the fetus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTNCI SB Immunotherapy Recruitment Center
PRINCIPAL_INVESTIGATORSteven A Rosenberg, M.D.
National Cancer Institute (NCI)
Outcome results
None listed