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Evaluation for NCI Surgery Branch Clinical Studies

This study is currently recruiting participants.
Verified October 3, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001823
First Posted: November 4, 1999
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

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


Condition
Synovial Cell Cancer Melanoma Colorectal Cancer Lung Cancer Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation for NCI Surgery Branch Clinical Research Protocols

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • 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. [ Time Frame: 20 Years ]
  • To assess frequency of HLA type and expression of neo antigens in malignant tumors across the population of cancer patients undergoing screening for NCI Surgery Branch Protocols. [ Time Frame: 20 years ]
  • Collect results of screening tests for use on subsequent researchprotocol as baseline (e.g., pretreatment) values. [ Time Frame: 20 years ]

Estimated Enrollment: 6000
Study Start Date: July 1, 1999
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 legal guardians (if the patient is less than 18 years of age), is able to understand and the willingness to sign a written informed consent document. Assent (verbal or written) will be obtained for participants under the age of 18 as appropriate.

Greater than or equal to 7 years of age and less than or equal to 70 years of age.

EXCLUSION CRITERIA:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001823


Contacts
Contact: Abigail R Johnson, R.N. (866) 820-4505 ncisbirc@mail.nih.gov
Contact: Steven A Rosenberg, M.D. (866) 820-4505 sar@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center    866-820-4505    ncisbirc@mail.nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00001823     History of Changes
Obsolete Identifiers: NCT00019799
Other Study ID Numbers: 990128
99-C-0128
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: October 19, 2017
Last Verified: October 3, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Cancer
Gene Therapy
Immunotherapy
Melanoma
Clinical Trial

Additional relevant MeSH terms:
Melanoma
Colorectal Neoplasms
Urinary Bladder Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases