Childhood Burkitt LymphomaNCT01623856
Studying Genes Associated With Non-Hodgkin Lymphoma in Young Patients
An observational study of Childhood Burkitt Lymphoma and Childhood Lymphoblastic Lymphoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
This research studies genes associated with non-Hodgkin lymphoma in young patients. Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer Read more about this study
- Who is it for?
- Ages Up to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Burkitt Lymphoma, Childhood Lymphoblastic Lymphoma
- What is being tested?
- laboratory biomarker analysis
- How many people
- 483 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2012
- 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 Up to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients diagnosed with lymphoblastic lymphoma (LL) or Burkitt lymphoma ( BL) enrolled on the Children Oncology Group (COG) protocols 5961, A5971, or ANHL01P1.
Who may be able to join
- Slides and/or other available specimens from patients diagnosed with lymphoblastic lymphoma (LL) or Burkitt lymphoma ( BL) enrolled on the Children Oncology Group (COG) protocols 5961, A5971, and ANHL01P1 collected at the time of diagnosis and currently housed at the Biopathology Center at Nationwide Children's Hospital
- Samples from non-Hispanic white patients
- DNA samples from 384 healthy, anonymous, non-Hispanic white blood donors used as controls
- See Disease Characteristics
- Not specified
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Monrovia, California, 91006-3776
About this study
Official title: Observational - Candidate Gene Variants and Childhood/Adolescent Non-Hodgkin Lymphoma: A Preliminary Investigation
This research studies genes associated with non-Hodgkin lymphoma in young patients. Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer
Read the detailed description
OBJECTIVES:
- To conduct a preliminary investigation of the effects of loci strongly and consistently associated in prior genome-wide association studies (GWAS) and validation studies of childhood/adolescent acute lymphoblastic leukemia (ALL), adult non-Hodgkin lymphoma (NHL), autoimmune diseases, and atopic diseases on the risk of NHL (lymphoblastic and Burkitt lymphomas) in children and adolescents.
OUTLINE:
DNA samples are analyzed by single nucleotide polymorphism and genotyped by fluorogenic polymerase chain reaction (PCR)-based allelic discrimination (Taqman) assays using the ABI Prism 7900HT reverse transcriptase (RT)-PCR system.
- Being tested
- laboratory biomarker analysis
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Observational | DNA samples are analyzed by single nucleotide polymorphism and genotyped by fluorogenic polymerase chain reaction (PCR)-based allelic discrimination (Taqman) assays using the ABI Prism 7900HT reverse transcriptase (RT)-PCR system. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential deviations from Hardy-Weinberg Equilibrium (HWE)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Burkitt LymphomaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amy Linabery, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623856
- Sponsor's protocol ID
- ANHL12B1
- Other IDs
- NCI-2012-01975
- Status last verified
- May 2015
- First submitted
- 15 Jun 2012
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational - Candidate Gene Variants and Childhood/Adolescent Non-Hodgkin Lymphoma: A Preliminary Investigation
- ClinicalTrials.gov ID
- NCT01623856
- Acronym / sponsor ID
- ANHL12B1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Jun 2012 (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.
This research studies genes associated with non-Hodgkin lymphoma in young patients. Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer
Detailed description
OBJECTIVES:
- To conduct a preliminary investigation of the effects of loci strongly and consistently associated in prior genome-wide association studies (GWAS) and validation studies of childhood/adolescent acute lymphoblastic leukemia (ALL), adult non-Hodgkin lymphoma (NHL), autoimmune diseases, and atopic diseases on the risk of NHL (lymphoblastic and Burkitt lymphomas) in children and adolescents.
OUTLINE:
DNA samples are analyzed by single nucleotide polymorphism and genotyped by fluorogenic polymerase chain reaction (PCR)-based allelic discrimination (Taqman) assays using the ABI Prism 7900HT reverse transcriptase (RT)-PCR system.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: laboratory biomarker analysisDNA samples are analyzed by single nucleotide polymorphism and genotyped by fluorogenic polymerase chain reaction (PCR)-based allelic discrimination (Taqman) assays using the ABI Prism 7900HT reverse transcriptase (RT)-PCR system. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with lymphoblastic lymphoma (LL) or Burkitt lymphoma ( BL) enrolled on the Children Oncology Group (COG) protocols 5961, A5971, or ANHL01P1.
Key inclusion criteria (5 listed)
- Slides and/or other available specimens from patients diagnosed with lymphoblastic lymphoma (LL) or Burkitt lymphoma ( BL) enrolled on the Children Oncology Group (COG) protocols 5961, A5971, and ANHL01P1 collected at the time of diagnosis and currently housed at the Biopathology Center at Nationwide Children's Hospital
- DNA samples from 384 healthy, anonymous, non-Hispanic white blood donors used as controls
- See Disease Characteristics
- Not specified
Key exclusion criteria (0 listed)
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 analysisCorrelative studies | Other | Observational |
Primary outcome
Potential deviations from Hardy-Weinberg Equilibrium (HWE)
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 7 May 2015.
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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.
Amy Linabery, MD principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Burkitt Lymphoma and Childhood Lymphoblastic Lymphoma, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Potential deviations from Hardy-Weinberg Equilibrium (HWE) (time frame: Baseline). 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 7 May 2015.