Localized OsteosarcomaNCT01807052
Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas
An observational study of Localized Osteosarcoma and Metastatic Osteosarcoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
This trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer Read more about this study
- Who is it for?
- Ages Up to 39 years
- Conditions the study is for
- Localized Osteosarcoma, Metastatic Osteosarcoma, Recurrent Osteosarcoma
- What is being tested?
- laboratory biomarker analysis
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to 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 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Tissue samples from patients with osteosarcomas obtained from the CHTN that participated in either study P9754 clinical trial for patients with non-metastatic osteosarcoma or AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma
Who may be able to join
- Tissue samples from patients with osteosarcomas obtained from the CHTN:
- P9754 clinical trial for patients with non-metastatic osteosarcoma
- AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma
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 - Tissue Factor Expression in Bone Sarcomas
This trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
Read the detailed description
STUDY SUBTYPE: Ancillary/Correlative
OBSERVATIONAL STUDY MODEL: Case-only
TIME PERSPECTIVE: Retrospective
BIOSPECIMEN RETENTION: Samples without DNA
BIOSPECIMEN DESCRIPTION: Tissue samples obtained from Cooperative Human Tissue Network (CHTN)
STUDY POPULATION DESCRIPTION: Patients enrolled on P9754 and AOST0121 clinical trials
SAMPLING METHOD: Non-probability sample
PRIMARY OBJECTIVES:
- To determine if there is differential expression of tumor factor (TF) among patients with osteosarcoma.
II. To determine if there is an association between overall survival and disease free survival and the extent of TF expression.
III. To determine if TF expression correlates with presence of gross metastatic disease at presentation, and development of subsequent metastases.
OUTLINE:
Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.
- Being tested
- laboratory biomarker analysis
- Medical subject headings
- Osteosarcoma
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 | Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of high TF expression
Estimated in the analytic population as the number of samples in the population in which such expression is noted divided by 33. An assessment of the precision of such estimates will be provided by an exact binomial confidence interval. Comparison of normalized TF expression in non-metastatic versus metastatic patients will be done using the two-sample t-test.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startNov 2009
- 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 Localized OsteosarcomaStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark Ranalli, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807052
- Sponsor's protocol ID
- AOST10B2
- Other IDs
- NCI-2013-00112, COG-AOST10B2
- Status last verified
- May 2016
- First submitted
- 6 Mar 2013
- 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
- Observational - Tissue Factor Expression in Bone Sarcomas
- ClinicalTrials.gov ID
- NCT01807052
- Acronym / sponsor ID
- AOST10B2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Mar 2013 (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 trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
Detailed description
STUDY SUBTYPE: Ancillary/Correlative
OBSERVATIONAL STUDY MODEL: Case-only
TIME PERSPECTIVE: Retrospective
BIOSPECIMEN RETENTION: Samples without DNA
BIOSPECIMEN DESCRIPTION: Tissue samples obtained from Cooperative Human Tissue Network (CHTN)
STUDY POPULATION DESCRIPTION: Patients enrolled on P9754 and AOST0121 clinical trials
SAMPLING METHOD: Non-probability sample
PRIMARY OBJECTIVES:
- To determine if there is differential expression of tumor factor (TF) among patients with osteosarcoma.
II. To determine if there is an association between overall survival and disease free survival and the extent of TF expression.
III. To determine if TF expression correlates with presence of gross metastatic disease at presentation, and development of subsequent metastases.
OUTLINE:
Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: laboratory biomarker analysisTissue samples are analyzed for tumor factor expression levels by immunohistochemistry. |
Who may qualify
- Ages
- Up to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Tissue samples from patients with osteosarcomas obtained from the CHTN that participated in either study P9754 clinical trial for patients with non-metastatic osteosarcoma or AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma
Key inclusion criteria (3 listed)
- Tissue samples from patients with osteosarcomas obtained from the CHTN:
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
Prevalence of high TF expression
Time frame: 1 month
Estimated in the analytic population as the number of samples in the population in which such expression is noted divided by 33. An assessment of the precision of such estimates will be provided by an exact binomial confidence interval. Comparison of normalized TF expression in non-metastatic versus metastatic patients will be done using the two-sample t-test.
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.
Related trials for Localized Osteosarcoma
RecruitingObservational study
Observational Study in Localized Osteosarcoma
Localized Osteosarcoma
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.
Mark Ranalli, 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 Localized Osteosarcoma and Metastatic Osteosarcoma, 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 3 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 19 May 2016. 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?
Prevalence of high TF expression (time frame: 1 month). 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; AzTrials last refreshed its copy on 29 Oct 2026.