Evaluation for NCI Surgery Branch Clinical Research Protocols

NCT00001823 | Recruiting

• 2 other identifiers: 99012899-C-0128
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Colorectal Cancer; Synovial Cell Cancer; Lung Cancer; Bladder Cancer

Keywords

Cancer; Gene Therapy; Immunotherapy; Clinical Trial

Outcome Measures

Primary Outcomes (3)

• Number of individuals suitable for NCI Surgery Branch clinical research protocols

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

  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

  25 years

• Results of screening tests

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

  25 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Melanoma; Colorectal Neoplasms; Lung Neoplasms; Urinary Bladder Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Steven A Rosenberg, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NCI SB Immunotherapy Recruitment Center

CONTACT

(866) 820-4505; irc@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: July 11, 1999
• Last Updated: May 1, 2026

Record last verified: 2025-12-17

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)