LymphomaNCT01490801
Biomarkers in Blood and Tissue Samples From Patients With Epstein-Barr Virus-Positive Hodgkin Lymphoma
An observational study of Lymphoma and Nonneoplastic Condition, run by Children's Oncology Group.
Trial summary
RATIONALE: 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 9 years
- Conditions the study is for
- Lymphoma, Nonneoplastic Condition
- What is being tested?
- DNA analysis, RNA analysis and cytogenetic analysis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to May 2016
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Diagnosis of Hodgkin lymphoma.
DISEASE CHARACTERISTICS:
- Diagnosis of Hodgkin lymphoma (HL) meeting the following criteria:
- Epstein-Barr virus-positive (EBV+) HL as assessed by positive EBV serology, elevated levels of EBV genome in the blood or tumor tissue following quantitative polymerase chain reaction (PCR) and/or evidence of EBV positivity of pathology samples (EBER+ or LMP+) and, when possible, mixed cellular histology
- Young age (< 10 years) at diagnosis
- Presence of hemophagocytic lymphohistiocytosis (HLH)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's Lymphoma
RATIONALE: 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.
PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients with Epstein-Barr virus positive Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
- Evaluate germline DNA from patients with Epstein-Barr virus positive (EBV+) and Hodgkin lymphoma (HL) for inducible T-cell kinase (ITK) mutations.
- Examine the effects of ITK mutations on expression of the ITK protein.
- Determine whether ITK mutations correlate with specific clinical or histopathological features of HL.
OUTLINE: Archived blood and tumor tissue samples are analyzed for germline DNA expression and inducible T-cell kinase (ITK) mutations by PCR, IHC, flow cytometry, and western blotting, and EBV-encoded RNA (EBER) using in situ hybridization. Each patient's data, such as date, sex, age, tumor stage and histology at diagnosis, treatment received, response to treatment, development of recurrent disease, date of last follow-up, and outcomes are also collected.
- Conditions
- Lymphoma, Nonneoplastic Condition
- Being tested
- DNA analysis, RNA analysis, cytogenetic analysis, in situ hybridization, mutation analysis
- Keywords
- childhood Hodgkin lymphoma, childhood mixed cellularity Hodgkin lymphoma, hemophagocytic lymphohistiocytosis, Epstein-Barr virus infection
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphohistiocytosis, Hemophagocytic, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
RNA analysisGenetic
cytogenetic analysisGenetic
in situ hybridizationGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
western blottingGenetic
flow cytometryOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of germline ITK mutations
Influence of ITK mutations on total expression levels or intracellular localization of the ITK protein
Correlation between ITK mutations with specific clinical or histopathological features of HL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kim E. Nichols, MD, BA, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490801
- Sponsor's protocol ID
- AHOD12B1
- Other IDs
- COG-AHOD12B1, AHOD12B1, NCI-2012-00089
- Status last verified
- May 2016
- First submitted
- 9 Dec 2011
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01490801
- Acronym / sponsor ID
- AHOD12B1
- Conditions
- Lymphoma, Nonneoplastic Condition
- Keywords
- childhood Hodgkin lymphoma, childhood mixed cellularity Hodgkin lymphoma, hemophagocytic lymphohistiocytosis, Epstein-Barr virus infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Dec 2011 (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 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.
PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients with Epstein-Barr virus positive Hodgkin lymphoma.
Detailed description
OBJECTIVES:
- Evaluate germline DNA from patients with Epstein-Barr virus positive (EBV+) and Hodgkin lymphoma (HL) for inducible T-cell kinase (ITK) mutations.
- Examine the effects of ITK mutations on expression of the ITK protein.
- Determine whether ITK mutations correlate with specific clinical or histopathological features of HL.
OUTLINE: Archived blood and tumor tissue samples are analyzed for germline DNA expression and inducible T-cell kinase (ITK) mutations by PCR, IHC, flow cytometry, and western blotting, and EBV-encoded RNA (EBER) using in situ hybridization. Each patient's data, such as date, sex, age, tumor stage and histology at diagnosis, treatment received, response to treatment, development of recurrent disease, date of last follow-up, and outcomes are also collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Diagnosis of Hodgkin lymphoma.
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 |
|---|---|---|
| DNA analysis | Genetic | – |
| RNA analysis | Genetic | – |
| cytogenetic analysis | Genetic | – |
| in situ hybridization | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| western blotting | Genetic | – |
| flow cytometry | Other | – |
| immunohistochemistry staining method | Other | – |
| medical chart review | Other | – |
Primary outcome
Presence of germline ITK mutations
Influence of ITK mutations on total expression levels or intracellular localization of the ITK protein
Correlation between ITK mutations with specific clinical or histopathological features of HL
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 17 May 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.
Kim E. Nichols, MD, BA principal investigator
Children's Hospital of Philadelphia
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Nonneoplastic Condition, run by Children's Oncology Group.
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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Presence of germline ITK mutations. The study lists 3 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 17 May 2016.