LymphomaNCT01366170
Biomarker Expression in Samples From Young Patients With Anaplastic Large Cell 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 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 20 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- microarray analysis, protein expression analysis and western blotting
- How many people
- 7 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Diagnosis of anaplastic large cell lymphoma.
DISEASE CHARACTERISTICS:
- Diagnosis of anaplastic large cell lymphoma
- Tissue microarray samples available from the Cooperative Human Tissue Network (CHTN)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Expression of T Immunoregulatory Proteins in ALK+ Anaplastic Large Cell Lymphoma (ALCL)
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.
PURPOSE: This research trial studies biomarker expression in tissue samples from young patients with anaplastic large cell lymphoma.
Read the detailed description
OBJECTIVES:
- To determine the expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in anaplastic large cell lymphoma (ALCL).
- To correlate the expression of these proteins with the levels of anaplastic lymphoma kinase (ALK) autoantibodies in patient of ANHL0131.
OUTLINE: Archived tissue microarray samples are analyzed by mass spectrometry and validated by Western blotting, flow cytometry, and IHC.
- Conditions
- Lymphoma
- Being tested
- microarray analysis, protein expression analysis, western blotting, flow cytometry, immunohistochemistry staining method
- Keywords
- childhood anaplastic large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microarray analysisGenetic
protein expression analysisGenetic
western blottingGenetic
flow cytometryOther
laboratory biomarker analysisOther
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in ALCL
Correlation of CD4, FOXP3, and CD276 with ALK autoantibody response in patients enrolled in ANHL0131
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
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
- Prospective
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Megan S. Lim, MD, PhD, Principal investigator, C.S. Mott Children's Hospital at University of Michigan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366170
- Sponsor's protocol ID
- ANHL11B1
- Other IDs
- COG-ANHL11B1, NCI-2011-02860, ANHL11B1
- Status last verified
- May 2016
- First submitted
- 2 Jun 2011
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of T Immunoregulatory Proteins in ALK+ Anaplastic Large Cell Lymphoma (ALCL)
- ClinicalTrials.gov ID
- NCT01366170
- Acronym / sponsor ID
- ANHL11B1
- Conditions
- Lymphoma
- Keywords
- childhood anaplastic large cell lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary 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 biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.
PURPOSE: This research trial studies biomarker expression in tissue samples from young patients with anaplastic large cell lymphoma.
Detailed description
OBJECTIVES:
- To determine the expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in anaplastic large cell lymphoma (ALCL).
- To correlate the expression of these proteins with the levels of anaplastic lymphoma kinase (ALK) autoantibodies in patient of ANHL0131.
OUTLINE: Archived tissue microarray samples are analyzed by mass spectrometry and validated by Western blotting, flow cytometry, and IHC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diagnosis of anaplastic large cell 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 | – |
| western blotting | Genetic | – |
| flow cytometry | Other | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| mass spectrometry | Other | – |
Primary outcome
Expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in ALCL
Correlation of CD4, FOXP3, and CD276 with ALK autoantibody response in patients enrolled in ANHL0131
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 19 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.
Megan S. Lim, MD, PhD principal investigator
C.S. Mott Children's Hospital at University of Michigan Medical Center
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 19 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?
Expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in ALCL. The study lists 2 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 19 May 2016.