Evaluation for NCI Surgery Branch Clinical Research Protocols
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Synovial Cell Cancer, Melanoma, Colorectal Cancer, Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Number of individuals suitable for NCI Surgery Branch clinical research protocols [Time frame: 25 Years]
- Frequency of HLA type, gene specific mutations, or expression of neoantigens in malignant tumors [Time frame: 25 years]
- Results of screening tests [Time frame: 25 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- National Institutes of Health Clinical Center — Bethesda
Identifiers
NCT: NCT00001823 · 990128 · 99-C-0128