Study of Tissue and Blood Samples From Patients With Low-Grade Glioma

NCT01004523 | Completed

• 4 other identifiers: NCCTG-94-72-53NCCTG-947253CDR0000406626NCI-2009-00689
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 38

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood low-grade cerebellar astrocytoma; childhood low-grade cerebral astrocytoma; childhood mixed glioma; adult mixed glioma; adult diffuse astrocytoma; childhood oligodendroglioma; adult oligodendroglioma

Outcome Measures

Primary Outcomes (5)

• 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

• Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies

  baseline

• DNA ploidy by FISH and flow cytometry

  baseline

• Percentage of cells in S-phase or G2M-phase as measured by flow cytometry

  baseline

Study Arms (1)

Single group

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.

Genetic: fluorescence in situ hybridization; Genetic: loss of heterozygosity analysis; Genetic: polymerase chain reaction; Other: flow cytometry; Other: immunohistochemistry staining method

Interventions

fluorescence in situ hybridization GENETIC

Single group

loss of heterozygosity analysis GENETIC

Single group

polymerase chain reaction GENETIC

Single group

flow cytometry OTHER

Single group

immunohistochemistry staining method OTHER

Single group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with low grade glioma.

1. Paraffin-embedded tumor tissue blocks of patients enrolled in NCCTG 86-72-51 or 93-72-02 and who had the diagnosis of low-grade glioma. 2. Patients who have the diagnosis of low-grade glioma with an available paraffin- embedded tumor tissue block enrolled in prospective NCCTG and Mayo studies.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (38)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

Clive, Iowa, 50325, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital - Monroe

Monroe, Michigan, 48162, United States

Location

MeritCare Bemidji

Bemidji, Minnesota, 56601, United States

Location

Essentia Health - Duluth Clinic

Duluth, Minnesota, 55805-1983, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller - Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, 58502, United States

Location

MeritCare Broadway

Fargo, North Dakota, 58102, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Community Cancer Center

Elyria, Ohio, 44035, United States

Location

Hematology Oncology Center

Elyria, Ohio, 44035, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537-1839, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43617, United States

Location

St. Anne Mercy Hospital

Toledo, Ohio, 43623, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, 22401, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue and blood samples

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioma; Astrocytoma; Oligodendroglioma

Interventions

In Situ Hybridization, Fluorescence; Polymerase Chain Reaction; Flow Cytometry; Immunohistochemistry

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Nucleic Acid Amplification Techniques; Cell Separation; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Histocytochemistry; Immunologic Techniques

Study Officials

• Jan Buckner, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: December 1, 1995
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

US (38)