Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With Osteosarcoma

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01374672
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 20
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 9.8

Study Details

Study Description

Brief Summary

This research study is studying biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma. Studying samples of tumor 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. It may also help doctors predict how patients will respond to treatment.

Condition or Disease	Intervention/Treatment	Phase
Localized Osteosarcoma; Metastatic Osteosarcoma; Osteoblastic Osteosarcoma; Recurrent Osteosarcoma	Other: laboratory biomarker analysis

Detailed Description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective:

Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Children's Oncology Group Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

1. Determine whether methylation status predicts response to neoadjuvant chemotherapy in samples from children and young adults with osteosarcoma.

OUTLINE: Patients are stratified according to response to neoadjuvant chemotherapy (good vs poor).

DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Observational - Methylation Status as Predictor of Response to Neoadjuvant Chemotherapy in Osteosarcoma
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Correlative studies DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.	Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Methylated status as predictor of response to neoadjuvant chemotherapy [Baseline]

   Performed on a locus-by-locus basis using Poisson regression (for count data) and/or two-group t-tests, with correction (Satterwaithe's) for unequal within-group variances.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with high-grade osteoblastic osteosarcoma

• Biopsy samples from patients who had good or poor response to neoadjuvant chemotherapy available

• All specimens should be from post-menarchal females or age-matched males with appendicular tumors

• Patients' clinical data including chemotherapy received, event-free survival, and overall survival available

• See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Oncology Group	Monrovia	California	United States	91006-3776

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jeremy Rosenblum, MD, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01374672
• Other Study ID Numbers: AOST11B1; NCI-2011-02861
• First Posted: Jun 16, 2011
• Last Update Posted: May 12, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Osteosarcoma

Study Results

No Results Posted as of May 12, 2015