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BRIEF TITLE: Evaluation for NCI Surgery Branch Clinical Research Protocols

Evaluation for NCI Surgery Branch Clinical Research Protocols


  • Org Study ID: 990128
  • Secondary ID: 99-C-0128
  • NCT ID: NCT00001823
  • NCT Alias: NCT00019799
  • Sponsor: National Cancer Institute (NCI) - NIH
  • Source: National Institutes of Health Clinical Center (CC)

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.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 25 Years

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

Primary Outcome 2 - Time Frame: 25 years

Primary Outcome 3 - Measure: Results of screening tests

Primary Outcome 3 - Time Frame: 25 years

Condition:

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

Eligibility

Criteria:
- 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:
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Gender: All

Minimum Age: 7 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Official Information

Name: Steven A Rosenberg, M.D.

Role: Principal Investigator

Affiliation: National Cancer Institute (NCI)

Overall Contact

Name: Margaret Shovlin, R.N.

Phone: (866) 820-4505

Email: IRC@nih.gov

Link: NIH Clinical Center Detailed Web Page

Location

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