ClinicalTrials.gg
RecruitingNCT00001823Updated Nov 9, 2026

Evaluation for NCI Surgery Branch Clinical Research Protocols

An observational study in Synovial Cell Cancer, Melanoma and Colorectal Cancer, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by National Cancer Institute (NCI) · Observational

From the registry’s dates

  • Started Jul 1999; still recruiting 27 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,000
Ages
18 Years and older
Sex
All
01

Study 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.

...

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.

02

Conditions studied

  • Synovial Cell Cancer
  • Melanoma
  • Colorectal Cancer
  • Lung Cancer
  • Bladder Cancer

Keywords

  • Cancer
  • Gene Therapy
  • Immunotherapy
  • Clinical Trial
03

In context

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

This study's planned enrollment of 7,000 is above the median of 187 across 488 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients suspected of having, or with biopsy proven, malignant disease.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age >= 18 years.

Patient suspected of having, or with proven, malignant disease.

Patient is able to understand and willing to sign a written document.

Patient is being evaluated for treatment on an NCI-SB protocols.

Exclusion criteria

EXCLUSION CRITERIA:

Women of 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,000 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Number of individuals suitable for NCI Surgery Branch clinical research protocols

    Total number of patients who enroll on NCI Surgery Branch clinical research protocols

    Time frame: 25 Years

  2. 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

    Time frame: 25 years

  3. Results of screening tests

    Results of screening tests for use on subsequent research protocol as baseline (e.g., pretreatment) values

    Time frame: 25 years

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Contact888-624-1937
08

References and documents

Individual participant data

Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Timeline

7 registry updates since Sep 25, 2026

Started Jul 1999 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Nov 4, 1999
StartActual
Jul 11, 1999
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description and verification date
7 updates, last Nov 9, 2026
Show all 7 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: description
  2. Nov 5, 2026
    Minor edits only
    + 1 other change: description
  3. Nov 2, 2026
    Minor edits only
    + 1 other change: verification date
  4. Oct 29, 2026
    Minor edits only
    + 1 other change: description
  5. Oct 26, 2026
    Minor edits only
    + 1 other change: verification date
  6. Oct 8, 2026
    Minor edits only
    + 1 other change: description
  7. Oct 2, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001823
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Jul 11, 1999
Last update
Nov 9, 2026

Study contacts

NCI SB Immunotherapy Recruitment Center
Contact
irc@nih.gov
(866) 820-4505
Steven A Rosenberg, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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