Collection of Tissue Blocks or Slides From Patients With Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT02810405
Collaborator
(none)
500
Enrollment
1
Location
135
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BACKGROUND:

Cancer of any type is a serious disease and despite all the progress made from past research, there is still much that is poorly understood at the molecular level. Recent advances in biomedical technology platforms have emerged as critical tools for accelerating personalized medicine. The collection of human tissue specimens has been an invaluable resource for conducting translational cancer research using these developing technologies. The ultimate goal is to understand the molecular indicators of cancer development and progression. While it is ideal to be able to study clinical samples, specifically tissue biopsies, they are however precious and are often difficult to obtain in sufficient quantities or numbers to conduct proteomic or molecular profiling studies. There exists, however, a vast archive of pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded tissue blocks. The preservation of these tissue blocks and/or slides for long-term (years) storage is an important asset that aids in translational and clinical research. This protocol will describe the procedures for receiving, labeling and storing paraffin-embedded tissue blocks and/or slides until they are needed for future analysis. When blocks are ready for analysis, the requestor will then follow the IRB protocol specific to that study.

OBJECTIVE:
  • To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).
ELIGIBILITY:
  • Patients suspected of having, or with biopsy proof of malignant disease will be evaluated in the Medical Oncology Branch and Affiliates Clinics, NCI.
DESIGN:
  • Tissue blocks and slides will be acquired from outside pathology departments and received by the Clinical Pharmacology Program of the MOB/CCR/NCI for coding.

  • Bar-coded tissue blocks and slides will then be transferred to the Laboratory of Pathology/CCR/NCI for proper long-term storage.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Background

    • Cancer of any type is a serious disease and despite all the progress made from past research, there is still much that is poorly understood at the molecular level.

    • Recent advances in biomedical technology platforms have emerged as critical tools for accelerating personalized medicine.

    • The collection of human tissue specimens has been an invaluable resource for conducting translational cancer research using these developing technologies.

    • The ultimate goal is to understand the molecular indicators of cancer development and progression.

    • While it is ideal to be able to study clinical samples, specifically tissue biopsies, they are however precious and are often difficult to obtain in sufficient quantities or numbers to conduct proteomic or molecular profiling studies.

    • There exists, however, a vast archive of pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded tissue blocks.

    • The preservation of these tissue blocks and/or slides for long-term (years) storage is an important asset that aids in translational and clinical research.

    • This protocol will describe the procedures for receiving, labeling and storing paraffinembedded tissue blocks and/or slides until they are needed for future analysis.

    • When blocks are ready for analysis, the requestor will then follow the IRB protocol specific to that study.

    Objective

    -To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Genitourinary Malignancies Branch (GMB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).

    Eligibility

    -Patients suspected of having, or with biopsy proof of malignant disease will be evaluated in the Genitourinary Malignancies Branch (GMB) and Affiliates Clinics, NCI.

    Design

    • This protocol is not a research study.

    • Tissue blocks and slides will be acquired from outside pathology departments and received by the Clinical Pharmacology Program of the OCD/CCR/NCI for coding.

    • Bar-coded tissue blocks and slides will then be transferred to the Laboratory of Pathology/CCR/NCI for proper long-term storage.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Collection of Tissue Blocks or Slides From Patients With Cancer
    Actual Study Start Date :
    Oct 3, 2011
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Study Completion Date :
    Jan 1, 2023

    Arms and Interventions

    ArmIntervention/Treatment
    1/Patient Samples

    Patients treated at NCI with available tissue samples

    Outcome Measures

    Primary Outcome Measures

    1. To obtain tissue blocks and slides in order to store them for future studies and analysis (e.g., using molecular technology platforms). [duration of protocol]

      To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Genitourinary Malignancies Branch (GMB)Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).

    Eligibility Criteria

    Criteria

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

    • Any cancer patient who is being evaluated at the National Cancer Institute with available tissue samples (blocks or slides) is eligible

    • Must be able and willing to sign an informed consent for this study

    • Age: greater than or equal to 18 years of age

    EXCLUSION CRITERIA:

    -None

    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: William D Figg, Pharm.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:
    NCT02810405
    Other Study ID Numbers:
    • 110190
    • 11-C-0190
    First Posted:
    Jun 23, 2016
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Aug 31, 2021
    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 Nov 18, 2021