Evaluation for NCI Surgery Branch Clinical Research Protocols

NCT ID: NCT00001823

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-07-11

Brief Summary

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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

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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.

Conditions

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Synovial Cell Cancer Melanoma Colorectal Cancer Lung Cancer Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven A Rosenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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NCI SB Immunotherapy Recruitment Center

Role: CONTACT

(866) 820-4505

Facility Contacts

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For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Role: primary

888-624-1937

Related Links

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Other Identifiers

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99-C-0128

Identifier Type: -

Identifier Source: secondary_id

990128

Identifier Type: -

Identifier Source: org_study_id

NCT00019799

Identifier Type: -

Identifier Source: nct_alias

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