Evaluation for NCI Surgery Branch Clinical Research Protocols
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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 : January 26, 2023
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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 |
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Synovial Cell Cancer Melanoma Colorectal Cancer Lung Cancer Bladder Cancer |
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.
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 7,000 patients has been set to meet the screening needs of the NCI-SB.
Study Type : | Observational |
Estimated Enrollment : | 7000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Evaluation for NCI Surgery Branch Clinical Research Protocols |
Actual Study Start Date : | July 11, 1999 |

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

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: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
Age >= 18 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.

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
Contact: NCI SB Immunotherapy Recruitment Center | (866) 820-4505 | irc@nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937 |
Principal Investigator: | Steven A Rosenberg, M.D. | National Cancer Institute (NCI) |
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: | January 26, 2023 |
Last Verified: | January 19, 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | .All IPD recorded in the medical record will be shared with intramural investigators upon request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Clinical data will be available during the study and indefinitely. |
Access Criteria: | Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cancer Gene Therapy Immunotherapy Clinical Trial |
Colorectal Neoplasms Urinary Bladder Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Urologic Neoplasms Urogenital Neoplasms Urinary Bladder Diseases Urologic Diseases |