Synovial Cell CancerNCT00001823
Evaluation for NCI Surgery Branch Clinical Research Protocols
An observational study of Synovial Cell Cancer and Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Synovial Cell Cancer, Melanoma, Colorectal Cancer
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 1999to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected of having, or with biopsy proven, malignant disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
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.
Read the 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.
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.
- Conditions
- Synovial Cell Cancer, Melanoma, Colorectal Cancer, Lung Cancer, Bladder Cancer
- Keywords
- Cancer, Gene Therapy, Immunotherapy, Clinical Trial
- Medical subject headings
- Melanoma, Colorectal Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals suitable for NCI Surgery Branch clinical research protocols
Total number of patients who enroll on NCI Surgery Branch clinical research protocols
Measured: 25 Years
Frequency of HLA type, gene specific mutations, or expression of neoantigens in malignant tumors
Frequency of HLA type, gene specific mutations, or expression of neoantigens in tissue and blood samples
Measured: 25 years
Results of screening tests
Results of screening tests for use on subsequent research protocol as baseline (e.g., pretreatment) values
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start11 Jul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synovial Cell CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven A Rosenberg, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001823
- Sponsor's protocol ID
- 990128
- Other IDs
- 99-C-0128
- Status last verified
- 22 Oct 2026
- First submitted
- 3 Nov 1999
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for NCI Surgery Branch Clinical Research Protocols
- ClinicalTrials.gov ID
- NCT00001823
- Acronym / sponsor ID
- 990128
- Conditions
- Synovial Cell Cancer, Melanoma, Colorectal Cancer, Lung Cancer, Bladder Cancer
- Keywords
- Cancer, Gene Therapy, Immunotherapy, Clinical Trial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Jul 1999 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of having, or with biopsy proven, malignant disease.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven A Rosenberg, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Synovial Cell Cancer and Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NCI SB Immunotherapy Recruitment Center ((866) 820-4505, irc@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals suitable for NCI Surgery Branch clinical research protocols (time frame: 25 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.