Collecting Solid Tumor Tissue to Identify New Treatments

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT01658917
Collaborator
(none)
133
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Background:

The NCI Surgery Branch 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 tissue samples obtained during the protocol screening process to be used for future and ongoing research in the NCI Surgery Branch

Eligibility:

Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment Protocol

Design

Patients will undergo testing and evaluations as required by the appropriate NCI Surgery Branch Treatment protocol

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    BACKGROUND:
    • Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer patients. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies.

    • The Surgery Branch, NCI has an interest in identifying novel molecular and biologic targets to facilitate the development of future cancer therapies. In addition, we have the primary responsibility for providing surgical consultative services to the NIH. As such, we are uniquely positioned to acquire and perform important studies on solid tumor tissue to help identify therapeutic targets that may have significant clinical ramifications.

    OBJECTIVES:
    • Primary Objective: To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets
    ELIGIBILITY:
    • Patients >= 18 years of age with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven solid neoplasms who require diagnostic or therapeutic intervention as a part of the diagnosis and /or standard of care treatment and/or follow up for their neoplasm

    • Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to planned intervention

    DESIGN:
    • A tissue acquisition trial in which tissues will be obtained at the time of intervention

    • Tissue and blood will be processed at the time of collection, stored and then transferred to Dr. Rosenberg s laboratory for further processing.

    • No investigational therapy will be given.

    • It is anticipated that 1000 patients will be enrolled over a period of ten years

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    133 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets
    Actual Study Start Date :
    Jul 24, 2012

    Arms and Interventions

    ArmIntervention/Treatment
    Primary

    Patients greater than or equal to 18 years of age who have premalignant, primary or metastatic solid tumors based upon either radiographic or biochemical testing, or histological/cytological analysis

    Outcome Measures

    Primary Outcome Measures

    1. To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors. [At time of surgery or biospy]

      To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets.

    Secondary Outcome Measures

    1. To collect detailed history, demographic, treatment data, and perioperative findings. [At time of consent]

      To collect detailed history, demographic, treatment data, and perioperative findings in order to categorize and track the specific procedures and outcomes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    • Patients must be greater than or equal to 18 years of age.

    • Patients who have a premalignant, primary or metastatic solid tumors based upon either radiographic or biochemical testing, or histological/cytological analysis that requires surgery or biopsy as a part of the standard of care diagnosis, treatment and/or follow up.

    • Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.

    • Patients must be planning to undergo surgery or biopsy as part of their treatment plan. Note: Patients will not be enrolled exclusively for the procurement of tissue samples.

    • Patients who agree to undergo leukapheresis must meet the following criteria:

    • Seronegative for HIV

    • Seronegative for hepatitis B surface antigen and seronegative for

    antibody to hepatitis C.

    • CBC within normal limits

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Steven A Rosenberg, M.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT01658917
    Other Study ID Numbers:
    • 120175
    • 12-C-0175
    First Posted:
    Aug 7, 2012
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Oct 4, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2022