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Evaluation for NCI Surgery Branch Clinical Research Protocols

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.
 
ClinicalTrials.gov Identifier: NCT00001823
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
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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.


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 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 and <= 70 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 6000 patients has been set to meet the screening needs of the NCI-SB.

Study Design
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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation for NCI Surgery Branch Clinical Research Protocols
Actual Study Start Date : July 11, 1999

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
A/Surgery Branch Protocol Candidates
Patients suspected of having, or with biopsy proven, malignant disease being evaluated for or treated on NCI Surgery Branch protocols


Outcome Measures
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Primary Outcome Measures :
  1. Number of individuals suitable for NCI Surgery Branch clinical research protocols [ Time Frame: 25 Years ]
    Total number of patients who enroll on NCI Surgery Branch clinical research protocols

  2. Frequency of HLA type, gene specific mutations, or expression of neoantigens in malignant tumors [ Time Frame: 25 years ]
    Frequency of HLA type, gene specific mutations, or expression of neoantigens in tissue and blood samples

  3. Results of screening tests [ Time Frame: 25 years ]
    Results of screening tests for use on subsequent research protocol as baseline (e.g., pretreatment) values


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient suspected of having, or with biopsy proven, malignant disease.
Criteria
  • INCLUSION CRITERIA:

Age >= 18 years and <= 70 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.

Contacts and Locations
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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
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Contact: For more information NCI/Surgery Branch Recruitment Center (866) 820-4505 IRC@nih.gov

Locations
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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
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Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)
More Information
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Additional Information:

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00001823    
Obsolete Identifiers: NCT00019799
Other Study ID Numbers: 990128
99-C-0128
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 9, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Cancer
Gene Therapy
Immunotherapy
Clinical Trial
Additional relevant MeSH terms:
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Colorectal Neoplasms
Urinary Bladder Neoplasms
Neoplasms
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