Brain and Central Nervous System TumorsNCT01004523
Study of Tissue and Blood Samples From Patients With Low-Grade Glioma
An observational study of Brain and Central Nervous System Tumors, run by Alliance for Clinical Trials in Oncology at 38 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- fluorescence in situ hybridization, loss of heterozygosity analysis and polymerase chain reaction
- How many people
- 135 participants
- Where
- 38 sitesUnited States
- Study dates
- Dec 1995to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with low grade glioma.
- 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.
- Patients who have the diagnosis of low-grade glioma with an available paraffin- embedded tumor tissue block enrolled in prospective NCCTG and Mayo studies.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221
MeritCare Bemidji
Bemidji, Minnesota, 56601
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502
Wood County Oncology Center
Bowling Green, Ohio, 43402
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, 50325
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Essentia Health - Duluth Clinic
Duluth, Minnesota, 55805-1983
CCOP - Duluth
Duluth, Minnesota, 55805
Miller - Dwan Medical Center
Duluth, Minnesota, 55805
Community Cancer Center
Elyria, Ohio, 44035
Hematology Oncology Center
Elyria, Ohio, 44035
MeritCare Broadway
Fargo, North Dakota, 58102
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Lima Memorial Hospital
Lima, Ohio, 45804
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839
Community Cancer Center of Monroe
Monroe, Michigan, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162
St. Charles Mercy Hospital
Oregon, Ohio, 43616
Toledo Clinic - Oregon
Oregon, Ohio, 43616
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
Flower Hospital Cancer Center
Sylvania, Ohio, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883
Toledo Hospital
Toledo, Ohio, 43606
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617
St. Anne Mercy Hospital
Toledo, Ohio, 43623
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623
Fulton County Health Center
Wauseon, Ohio, 43567
About this study
Official title: Diagnostic and Prognostic Markers in Low-Grade Gliomas
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- fluorescence in situ hybridization, loss of heterozygosity analysis, polymerase chain reaction, flow cytometry, immunohistochemistry staining method
- Keywords
- childhood low-grade cerebellar astrocytoma, childhood low-grade cerebral astrocytoma, childhood mixed glioma, adult mixed glioma, adult diffuse astrocytoma, childhood oligodendroglioma, adult oligodendroglioma
- Medical subject headings
- Central Nervous System Neoplasms, Glioma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence in situ hybridizationGenetic
loss of heterozygosity analysisGenetic
polymerase chain reactionGenetic
flow cytometryOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: fluorescence in situ hybridization; Genetic: loss of heterozygosity analysis; Genetic: polymerase chain reaction; Other: flow cytometry; Other: immunohistochemistry staining method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH
Measured: baseline
Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis
Measured: baseline
Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies
Measured: baseline
DNA ploidy by FISH and flow cytometry
Measured: baseline
Percentage of cells in S-phase or G2M-phase as measured by flow cytometry
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startDec 1995
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jan Buckner, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004523
- Sponsor's protocol ID
- NCCTG-94-72-53
- Other IDs
- NCCTG-947253, CDR0000406626, NCI-2009-00689
- Status last verified
- Jul 2016
- First submitted
- 29 Oct 2009
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Markers in Low-Grade Gliomas
- ClinicalTrials.gov ID
- NCT01004523
- Acronym / sponsor ID
- NCCTG-94-72-53
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1995
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Genetic: fluorescence in situ hybridization, Genetic: loss of heterozygosity analysis, Genetic: polymerase chain reaction, Other: flow cytometry, Other: immunohistochemistry staining methodPreviously 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with low grade glioma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH
Time frame: baseline
Loss of chromosomal materials in chromosomes 9p, 10, 13, 17, or 22 by PCR analysis
Time frame: baseline
Levels of PCNA, Ki-67 (MIB-1), or mutated p53 by immunostaining with monoclonal antibodies
Time frame: baseline
DNA ploidy by FISH and flow cytometry
Time frame: baseline
Percentage of cells in S-phase or G2M-phase as measured by flow cytometry
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Buckner, MD study chair
Mayo Clinic
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors, run by Alliance for Clinical Trials in Oncology at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in chromosomes 7, 9p, 10, 17, 19q, X, or Y as determined by FISH (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.