Evaluation for NCI Surgery Branch Clinical Research Protocols

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT00001823

Collaborator

(none)

7,000

Enrollment

Location

Study Details

Study Description

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.

...

Condition or Disease	Intervention/Treatment	Phase
Synovial Cell Cancer Melanoma Colorectal Cancer Lung Cancer Bladder Cancer

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

7000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation for NCI Surgery Branch Clinical Research Protocols

Actual Study Start Date :

Jul 11, 1999

Arms and Interventions

Arm	Intervention/Treatment
A/Surgery Branch Protocol Candidates Patients suspected of having, or with biopsy proven, malignant disease being evaluated for or treated on NCI Surgery Branch protocols

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.