LeukemiaNCT00003933
Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia
A study testing laboratory biomarker analysis in people with Leukemia, run by Children's Oncology Group at 41 sites in 3 countries.
Trial summary
RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease. PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Leukemia
- What is being tested?
- laboratory biomarker analysis
- How many people
- Not given
- Where
- 41 sitesin 3 countries
- Study dates
- Apr 1999to Apr 2006
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphocytic leukemia and treated on protocol CCG-1941
- Material cryopreserved in the CCG cell bank
PATIENT CHARACTERISTICS:
Age:
- Children
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- See Disease Characteristics
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
United States38 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
Children's Hospital of Denver
Denver, Colorado, 80218
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
Children's Mercy Hospital
Kansas City, Missouri, 64108
Long Beach Memorial Medical Center
Long Beach, California, 90806
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901-1780
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
David Grant Medical Center
Travis Air Force Base, California, 94535
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Canada2 sites
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: The Incidence and Prognostic Significance of P16 INK4A/ P15 INK4B Gene Alterations in Children With Relapsed ALL Treated on CCG-1941
RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease.
PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
- Determine the incidence of p16/p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941.
- Determine the prognostic importance of p16/p15 abnormalities in these children.
- Determine the presence or absence of p16/p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients.
OUTLINE: Frozen cells are obtained from samples collected on protocol CCG-1941. DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 and/or p15.
PROJECTED ACCRUAL: Approximately 100 samples will be obtained for this study.
- Conditions
- Leukemia
- Being tested
- laboratory biomarker analysis
- Keywords
- recurrent childhood acute lymphoblastic leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2003 (estimated)
- Study startApr 1999
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen P. Hunger, MD, Study chair, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003933
- Sponsor's protocol ID
- B9805
- Other IDs
- COG-B9805, CCG-B9805, CDR0000067125
- Status last verified
- Aug 2014
- First submitted
- 1 Nov 1999
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Prognostic Significance of P16 INK4A/ P15 INK4B Gene Alterations in Children With Relapsed ALL Treated on CCG-1941
- ClinicalTrials.gov ID
- NCT00003933
- Acronym / sponsor ID
- B9805
- Conditions
- Leukemia
- Keywords
- recurrent childhood acute lymphoblastic leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1999
- Primary completion
- Apr 2006 (actual)
- First posted
- 2 May 2003 (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: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease.
PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia.
Detailed description
OBJECTIVES:
- Determine the incidence of p16/p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941.
- Determine the prognostic importance of p16/p15 abnormalities in these children.
- Determine the presence or absence of p16/p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients.
OUTLINE: Frozen cells are obtained from samples collected on protocol CCG-1941. DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 and/or p15.
PROJECTED ACCRUAL: Approximately 100 samples will be obtained for this study.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
Primary outcome
Not reported in the source record.
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 7 Aug 2014.
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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.
Stephen P. Hunger, MD study chair
University of Florida
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laboratory biomarker analysis in people with Leukemia, run by Children's Oncology Group at 41 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada, Australia. 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.
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 7 Aug 2014.