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Brief Title: Evaluation for NCI Surgery Branch Clinical Studies

Evaluation for NCI Surgery Branch Clinical Research Protocols

INTRODUCTION

  • Org Study ID: 990128
  • Secondary ID: 99-C-0128
  • NTC ID: NCT00001823
  • Sponsor: National Cancer Institute (NCI)

BRIEF SUMMARY


Background:

The NCI Surgery Branch 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 NCI
Surgery Branch Protocols

Eligibility:

Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment
Protocol

Design

Patients will undergo testing and evaluations as required by the appropriate NCI Surgery
Branch 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 Surgery Branch
research protocols.

Objectives:

To permit evaluation of patients referred to the NCI Surgery Branch in order to identify
individuals who will be suitable candidates for Surgery Branch 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
Surgery Branch Protocols.

Collect results of screening tests for use on subsequent research protocol as baseline (e.g.,
pretreatment) values.

Eligibility:

Patient suspected of having, or with biopsy proven malignant disease.

Patient, parent or guardian (if a minor), is able to provide informed consent.

Patients who are being evaluated for or treated on NCI Surgery Branch protocols.

Design:

Patients enrolled on this protocol will be evaluated by NCI Surgery Branch physicians to
determine the individual's suitability for participation in a clinical research protocol. An
accrual ceiling of 6000 patients has been set to meet the screening needs of the Surgery
Branch.


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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Identify individuals suitable for Surgery Branch clinical research protocols

Primary Outcome 1 - Timeframe: 25 Years

Primary Outcome 2 - Measure: Frequency of HLA type, gene specific mutations, or expression of neo antigens in malignant tumors

Primary Outcome 2 - Timeframe: 25 years

Primary Outcome 3 - Measure: Results of screening tests

Primary Outcome 3 - Timeframe: 25 years

CONDITION

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

ELIGIBILITY


- INCLUSION CRITERIA:

Patients suspected of having, or with biopsy proven, malignant disease.

Patients who are being evaluated for or treated on NCI Surgery Branch protocols.

Patient, or their parent(s) legal guardian(s) (if the patient is less than 18 years of
age), is able to understand and willing to sign a written informed consent document. Assent
(verbal or written) will be obtained for participants under the age of 18 as appropriate.

Age greater than 7 and less than 70 years

EXCLUSION CRITERIA:

None

Gender: All

Minimum Age: 70 Years

Maximum Age: 7 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Steven A Rosenberg, M.D.

Role: Principal Investigator

Affiliation: National Cancer Institute (NCI)

Overall Contact

Name: Steven A Rosenberg, M.D.

Phone: (866) 820-4505

Email: IRC@nih.gov

LOCATION

Facility Status Contact
Facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland 20892
United States 		Status: Recruiting Contact:
For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center
866-820-4505
irc@nih.gov

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