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Brief Title: Evaluation for NCI Surgery Branch Clinical Studies

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Evaluation for NCI Surgery Branch Clinical Research Protocols

INTRODUCTION

  • Org Study ID: 990128
  • Secondary ID: N/A
  • NCT ID: NCT00001823
  • Sponsor: National Cancer Institute (NCI)

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.

  • Overall Status
    Recruiting
  • Start Date
    July 11, 1999
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of individuals suitable for NCI Surgery Branch clinical research protocols

Primary Outcome 1 - Timeframe: 25 Years

Primary Outcome 2 - Measure: Frequency of HLA type

Primary Outcome 2 - Timeframe: 25 years

Primary Outcome 3 - Measure: gene specific mutations

Primary Outcome 3 - Timeframe: 25 years

Primary Outcome 4 - Measure: or expression of neoantigens in malignant tumors

Primary Outcome 4 - Timeframe: N/A

Primary Outcome 5 - Measure: Results of screening tests

Primary Outcome 5 - Timeframe: N/A

CONDITION

  • Synovial Cell Cancer
  • Melanoma
  • Colorectal Cancer
  • Lung Cancer
  • Bladder Cancer

ELIGIBILITY

* 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Steven A Rosenberg, M.D.

Role: Principal Investigator

Affiliation: National Cancer Institute (NCI)

Overall Contact

Name: NCI SB Immunotherapy Recruitment Center

Phone: (866) 820-4505

Email: [email protected]

LOCATION

Facility Status Contact
Facility: National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United States 		Status: Recruiting Contact: Contact
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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