Disseminated NeuroblastomaNCT01358617
Prognostic Biomarkers in Tumor Tissue Samples From Young Patients With Neuroblastoma
An observational study of Disseminated Neuroblastoma and Localized Resectable Neuroblastoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
This research study is studying biomarkers in tumor tissue samples from young patients with neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify biomarkers and learn more about biomarkers related to cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disseminated Neuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma
- What is being tested?
- diagnostic laboratory biomarker analysis
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients With Neuroblastoma
Who may be able to join
- Diagnosed with neuroblastoma
- Tissue microarrays containing normal and neuroblastoma samples provided by the Children's Oncology Group (COG) Biopathology Center
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 - Expression of Ubiquitin Carboxyl-Terminal Hydrolase 1 (UCHL1) in Neuroblastoma Cancer Stem Cells and Its Relationship to Patient Prognosis
This research study is studying biomarkers in tumor tissue samples from young patients with neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify biomarkers and learn more about biomarkers related to cancer
Read the detailed description
PRIMARY OBJECTIVES:
- Determine whether ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression is an indirect cancer stem cell marker in pediatric patients with neuroblastoma. Correlate UCHL1 expression with staging information and patient's outcome.
Study Subtype: Observational Observational Study Model: Case-control Time Perspective: Retrospective Biospecimen Retention: None Retained Biospecimen Description: Tissue Study Population Description: Tissue microarray samples from patients with Neuroblastoma supplied by the COG Biopathology Center Sampling Method: Probability
OUTLINE:
Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique. Results are then compared with patients' clinical data, including age at diagnosis, race, date of diagnosis, histology, stage and location at diagnosis, presence of cancer predisposition, date of completion of treatment, surgery performed, type of chemotherapy received, history of recurrence, and status (alive with disease, alive without disease, dead), if available.
- Conditions
- Disseminated Neuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Stage 4S Neuroblastoma
- Being tested
- diagnostic laboratory biomarker analysis
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Biomarker analysis | Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique. Receives: Other: diagnostic laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between test result (percent cells with positive UCHL1 staining dichotomized into high and low categories) and International Neuroblastoma Staging System (INSS) stage
Measured: Baseline
Secondary outcomes (1)
Relationship between UCHL1 expression and tumor histology, and MYCN amplification
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disseminated NeuroblastomaStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aaron Sugalski, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358617
- Sponsor's protocol ID
- ANBL11B3
- Other IDs
- NCI-2011-02856, U10CA098543
- Status last verified
- May 2015
- First submitted
- 19 May 2011
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational - Expression of Ubiquitin Carboxyl-Terminal Hydrolase 1 (UCHL1) in Neuroblastoma Cancer Stem Cells and Its Relationship to Patient Prognosis
- ClinicalTrials.gov ID
- NCT01358617
- Acronym / sponsor ID
- ANBL11B3
- Conditions
- Disseminated Neuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Stage 4S Neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 May 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.
This research study is studying biomarkers in tumor tissue samples from young patients with neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify biomarkers and learn more about biomarkers related to cancer
Detailed description
PRIMARY OBJECTIVES:
- Determine whether ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression is an indirect cancer stem cell marker in pediatric patients with neuroblastoma. Correlate UCHL1 expression with staging information and patient's outcome.
Study Subtype: Observational Observational Study Model: Case-control Time Perspective: Retrospective Biospecimen Retention: None Retained Biospecimen Description: Tissue Study Population Description: Tissue microarray samples from patients with Neuroblastoma supplied by the COG Biopathology Center Sampling Method: Probability
OUTLINE:
Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique. Results are then compared with patients' clinical data, including age at diagnosis, race, date of diagnosis, histology, stage and location at diagnosis, presence of cancer predisposition, date of completion of treatment, surgery performed, type of chemotherapy received, history of recurrence, and status (alive with disease, alive without disease, dead), if available.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker analysis | – | Other: diagnostic laboratory biomarker analysisArchived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients With Neuroblastoma
Key inclusion criteria (2 listed)
- Diagnosed with neuroblastoma
- Tissue microarrays containing normal and neuroblastoma samples provided by the Children's Oncology Group (COG) Biopathology Center
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 |
|---|---|---|
| diagnostic laboratory biomarker analysisCorrelative studies | Other | Biomarker analysis |
Primary outcome
Association between test result (percent cells with positive UCHL1 staining dichotomized into high and low categories) and International Neuroblastoma Staging System (INSS) stage
Time frame: Baseline
1 secondary outcome
Relationship between UCHL1 expression and tumor histology, and MYCN amplification
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 12 May 2015.
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.
Aaron Sugalski, 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 Disseminated Neuroblastoma and Localized Resectable Neuroblastoma, 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 2 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 12 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?
Association between test result (percent cells with positive UCHL1 staining dichotomized into high and low categories) and International Neuroblastoma Staging System (INSS) stage (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 12 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.