Study of Tissue and Blood Samples From Patients With Low-Grade Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Genetic: fluorescence in situ hybridizationGenetic: loss of heterozygosity analysisGenetic: polymerase chain reactionOther: flow cytometryOther: immunohistochemistry staining method
- Registration Number
- NCT01004523
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at tissue and blood samples from patients with low-grade glioma.
- Detailed Description
OBJECTIVES:
* Evaluate the diagnostic and prognostic relevance of alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y, using PCR analysis of microsatellite repeats and FISH.
* Evaluate the diagnostic and prognostic relevance of DNA ploidy by flow cytometric analysis; compare with ploidy determination by FISH.
* Assess the diagnostic and prognostic relevance of various markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single group polymerase chain reaction Previously preserved paraffin-embedded tissue blocks are obtained and used for biomarker studies. Blood samples obtained during treatment are also obtained. Loss of heterozygosity of specific chromosomal regions are performed using PCR analysis of microsatellite repeats (41,118-120) on DNA extracted from the paraffin-embedded archival specimens. FISH and flow cytometry may also be used to assess chromosomal loss of deletion. Immunohistochemistry is also performed. Single group loss of heterozygosity analysis Previously preserved paraffin-embedded tissue blocks are obtained and used for biomarker studies. Blood samples obtained during treatment are also obtained. Loss of heterozygosity of specific chromosomal regions are performed using PCR analysis of microsatellite repeats (41,118-120) on DNA extracted from the paraffin-embedded archival specimens. FISH and flow cytometry may also be used to assess chromosomal loss of deletion. Immunohistochemistry is also performed. Single group flow cytometry Previously preserved paraffin-embedded tissue blocks are obtained and used for biomarker studies. Blood samples obtained during treatment are also obtained. Loss of heterozygosity of specific chromosomal regions are performed using PCR analysis of microsatellite repeats (41,118-120) on DNA extracted from the paraffin-embedded archival specimens. FISH and flow cytometry may also be used to assess chromosomal loss of deletion. Immunohistochemistry is also performed. Single group fluorescence in situ hybridization Previously preserved paraffin-embedded tissue blocks are obtained and used for biomarker studies. Blood samples obtained during treatment are also obtained. Loss of heterozygosity of specific chromosomal regions are performed using PCR analysis of microsatellite repeats (41,118-120) on DNA extracted from the paraffin-embedded archival specimens. FISH and flow cytometry may also be used to assess chromosomal loss of deletion. Immunohistochemistry is also performed. Single group immunohistochemistry staining method Previously preserved paraffin-embedded tissue blocks are obtained and used for biomarker studies. Blood samples obtained during treatment are also obtained. Loss of heterozygosity of specific chromosomal regions are performed using PCR analysis of microsatellite repeats (41,118-120) on DNA extracted from the paraffin-embedded archival specimens. FISH and flow cytometry may also be used to assess chromosomal loss of deletion. Immunohistochemistry is also performed.
- Primary Outcome Measures
Name Time Method Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies baseline DNA ploidy by FISH and flow cytometry baseline Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH baseline Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis baseline Percentage of cells in S-phase or G2M-phase as measured by flow cytometry baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸Clive, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
St. Anne Mercy Hospital
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Hematology Oncology Center
🇺🇸Elyria, Ohio, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Community Cancer Center
🇺🇸Elyria, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Essentia Health - Duluth Clinic
🇺🇸Duluth, Minnesota, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States