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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01374672
First received: June 15, 2011
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

RATIONALE: 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.

PURPOSE: This research study is studying biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma.


Condition Intervention
Sarcoma
Drug: systemic chemotherapy
Genetic: DNA methylation analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Official Title: Methylation Status as Predictor of Response to Neoadjuvant Chemotherapy in Osteosarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Methylated status as predictor of response to neoadjuvant chemotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374672

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Jeremy Rosenblum, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01374672     History of Changes
Other Study ID Numbers: CDR0000702111, COG-AOST11B1
Study First Received: June 15, 2011
Last Updated: July 28, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
osteoblastic osteosarcoma
localized osteosarcoma
metastatic osteosarcoma
recurrent osteosarcoma

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on September 16, 2014