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Evaluation for NCI Surgery Branch Clinical Studies

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ClinicalTrials.gov Identifier: NCT00001823
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( 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


Condition or disease
Synovial Cell Cancer Melanoma Colorectal Cancer Lung Cancer Bladder Cancer

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.


Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation for NCI Surgery Branch Clinical Research Protocols
Study Start Date : July 1, 1999





Primary Outcome Measures :
  1. Individuals suitable for Surgery Branch clinical research protocols [ Time Frame: 20 Years ]
    Total number of patients who enroll on Surgery Branch clinical research protocols

  2. Frequency of HLA type and expression of neo antigens in malignant tumors [ Time Frame: 20 years ]
    Frequency of HLA type and expression of neo antigens in tissue and blood samples

  3. Results of screening tests for use on subsequent research protocol asbaseline (e.g., pretreatment) values [ Time Frame: 20 years ]
    Aggregate results of screening tests



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Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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:


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: Margaret Shovlin, R.N. (866) 820-4505 IRC@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    irc@nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)

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 Posted: November 4, 1999    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: May 24, 2018

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