LymphomaNCT01366157
Protein Biomarker Levels in Tissue Samples From Young Patients With Low-risk Hodgkin Lymphoma
An observational study of Lymphoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and 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?
- Ages Up to 21 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- microarray analysis, protein expression analysis and immunohistochemistry staining method
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- May 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Diagnosed with low-risk classical Hodgkin lymphoma
DISEASE CHARACTERISTICS:
- Diagnosed with low-risk classical Hodgkin lymphoma (cHL)
- Samples available from patients enrolled in the low-risk study COG-AHOD0431 and in the intermediate-risk cHL study COG-AHOD0031
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Investigation to Evaluate the Levels of Human Germinal-center-Associated Lymphoma (HGAL) Protein in Pediatric Hodgkin Lymphoma and Correlate With Early Response
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and 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 trial is studying protein biomarker levels in tissue samples from young patients with low-risk Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
- To investigate the variability of expression of human geminal-center-associated lymphoma (HGAL) protein in pediatric low-risk Hodgkin lymphoma.
- To assess the variability of HGAL staining between risk groups by comparing samples from subjects enrolled in the low-risk study AHOD0431 with subject samples enrolled in AHOD0031 for intermediate-risk classical Hodgkin Lymphoma (cHL).
- To assess the variability of HGAL staining by evaluating a tissue array created from subjects with intermediate-risk cHL.
- To correlate rapid or slow early-response in the intermediate-risk group with HGAL protein expression.
OUTLINE: Paraffin-embedded tissue samples and tissue microarrays are analyzed for protein expression by IHC.
- Conditions
- Lymphoma
- Being tested
- microarray analysis, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- childhood favorable prognosis Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, childhood lymphocyte depletion Hodgkin lymphoma, childhood lymphocyte predominant Hodgkin lymphoma, childhood mixed cellularity Hodgkin lymphoma, childhood nodular lymphocyte predominant Hodgkin lymphoma, childhood nodular sclerosis Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microarray analysisGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of HGAL protein expression in pediatric patients with low-risk classical Hodgkin lymphoma (cHL)
Variability of HGAL staining between low-risk and intermediate-risk pediatric patients with cHL
Variability of HGAL staining as assessed by tissue array in pediatric patients with intermediate-risk cHL
Correlation of rapid or slow early response in the intermediate-risk group with HGAL protein expression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frank G. Keller, MD, Principal investigator, Emory Children's Center - Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366157
- Sponsor's protocol ID
- AHOD11B1
- Other IDs
- COG-AHOD11B1, CDR0000701020, NCI-2011-02859
- Status last verified
- May 2016
- First submitted
- 2 Jun 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
- Investigation to Evaluate the Levels of Human Germinal-center-Associated Lymphoma (HGAL) Protein in Pediatric Hodgkin Lymphoma and Correlate With Early Response
- ClinicalTrials.gov ID
- NCT01366157
- Acronym / sponsor ID
- AHOD11B1
- Conditions
- Lymphoma
- Keywords
- childhood favorable prognosis Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, childhood lymphocyte depletion Hodgkin lymphoma, childhood lymphocyte predominant Hodgkin lymphoma, childhood mixed cellularity Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Jun 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 tissue from patients with cancer in the laboratory may help doctors identify and 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 trial is studying protein biomarker levels in tissue samples from young patients with low-risk Hodgkin lymphoma.
Detailed description
OBJECTIVES:
- To investigate the variability of expression of human geminal-center-associated lymphoma (HGAL) protein in pediatric low-risk Hodgkin lymphoma.
- To assess the variability of HGAL staining between risk groups by comparing samples from subjects enrolled in the low-risk study AHOD0431 with subject samples enrolled in AHOD0031 for intermediate-risk classical Hodgkin Lymphoma (cHL).
- To assess the variability of HGAL staining by evaluating a tissue array created from subjects with intermediate-risk cHL.
- To correlate rapid or slow early-response in the intermediate-risk group with HGAL protein expression.
OUTLINE: Paraffin-embedded tissue samples and tissue microarrays are analyzed for protein expression by IHC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diagnosed with low-risk classical 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 |
|---|---|---|
| microarray analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Variability of HGAL protein expression in pediatric patients with low-risk classical Hodgkin lymphoma (cHL)
Variability of HGAL staining between low-risk and intermediate-risk pediatric patients with cHL
Variability of HGAL staining as assessed by tissue array in pediatric patients with intermediate-risk cHL
Correlation of rapid or slow early response in the intermediate-risk group with HGAL protein expression
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.
Frank G. Keller, MD principal investigator
Emory Children's Center - Atlanta
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, 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?
Variability of HGAL protein expression in pediatric patients with low-risk classical Hodgkin lymphoma (cHL). The study lists 4 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.