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Collection of Tissue Blocks or Slides From Patients With Cancer

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ClinicalTrials.gov Identifier: NCT02810405
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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 disease
Tumor Carcinogens Neoplasm, Benign Benign Neoplasms Cancer

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Collection of Tissue Blocks or Slides From Patients With Cancer
Study Start Date : June 10, 2011
Estimated Primary Completion Date : January 1, 2023
Study Completion Date : January 1, 2023

Group/Cohort
Patient Samples
Patients treated at NCI with available tissue samples



Primary Outcome Measures :
  1. 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 ... [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
any cancer patient who is being evaluated at the NCI with available tissue samples
Criteria
  • 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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810405


Contacts
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Contact: Paula A Carter, R.N. (240) 858-3191 pcartera@mail.nih.gov
Contact: William D Figg, Pharm.D. (240) 760-6179 wdfigg@helix.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)

Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02810405     History of Changes
Other Study ID Numbers: 110190
11-C-0190
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 8, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Sample
Storage
Molecular Profiling
Biopsy
Repository

Additional relevant MeSH terms:
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Neoplasms