Clinical trial NCT00001823: Evaluation for NCI Surgery Branch Clinical Research Protocols
Official title: Evaluation for NCI Surgery Branch Clinical Research Protocols
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Synovial Cell Cancer
Melanoma
Colorectal Cancer
Lung Cancer
Bladder Cancer
Keywords: Cancer
Gene Therapy
Immunotherapy
Clinical Trial
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected of having, or with biopsy proven, malignant disease.

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.

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.

Primary outcomes:
measure: Number of individuals suitable for NCI Surgery Branch clinical research protocols
timeFrame: 25 Years
measure: Frequency of HLA type, gene specific mutations, or expression of neoantigens in malignant tumors
timeFrame: 25 years
measure: Results of screening tests
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Steven A Rosenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: