Clinical trial NCT02810405: Collection of Tissue Blocks or Slides From Patients With Cancer
Official title: Collection of Tissue Blocks or Slides From Patients With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor
Carcinogens
Neoplasm, Benign
Benign Neoplasms
Cancer
Keywords: Sample
Storage
Molecular Profiling
Biopsy
Repository
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2016-06-23
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any cancer patient who is being evaluated at the NCI with available tissue samples

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.

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.

Eligibility 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:

-None

Primary outcomes:
measure: To obtain tissue blocks and slides in order to store them for future studies and analysis (e.g., using molecular technology platforms).
timeFrame: duration of protocol
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: William D Figg, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Voduc D, Kenney C, Nielsen TO. Tissue microarrays in clinical oncology. Semin Radiat Oncol. 2008 Apr;18(2):89-97. doi: 10.1016/j.semradonc.2007.10.006.
citation: Sauter G, Simon R, Hillan K. Tissue microarrays in drug discovery. Nat Rev Drug Discov. 2003 Dec;2(12):962-72. doi: 10.1038/nrd1254. No abstract available.
citation: Blonder J, Veenstra TD. Clinical proteomic applications of formalin-fixed paraffin-embedded tissues. Clin Lab Med. 2009 Mar;29(1):101-13. doi: 10.1016/j.cll.2009.01.006.