Clinical Trials Logo
  1. Home
  2. Recurrent Osteosarcoma
  3. NCT01374672
  4. Details
NCT01374672 Clinical Trial

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

Recurrent Osteosarcoma Clinical Trial

Official title:
Observational - Methylation Status as Predictor of Response to Neoadjuvant Chemotherapy in Osteosarcoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01374672
Other study ID # AOST11B1
Secondary ID NCI-2011-02861
Status Completed
Phase N/A
First received June 15, 2011
Last updated May 8, 2015
Start date July 2011
Est. completion date September 2011

Study information
Verified date May 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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:

I. 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 20 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations
Country Name City State
United States Children's Oncology Group Monrovia California

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Methylated status as predictor of response to neoadjuvant chemotherapy 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. Baseline No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06041490 - Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation Phase 2
Not yet recruiting NCT05515068 - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Completed NCT00093821 - Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors Phase 1
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Completed NCT01553539 - Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery Phase 2
Completed NCT00091182 - Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment Phase 2
Completed NCT00004078 - Irinotecan in Treating Children With Refractory Solid Tumors Phase 2
Completed NCT00004241 - 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma Phase 1
Active, not recruiting NCT04284774 - Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial Phase 2
Recruiting NCT04851119 - Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors Phase 1/Phase 2
Active, not recruiting NCT03213678 - Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT04668300 - Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma Phase 2
Completed NCT02470091 - Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma Phase 2
Completed NCT01807052 - Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas N/A
Completed NCT01016015 - Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma Phase 2
Active, not recruiting NCT03698994 - Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Active, not recruiting NCT03213665 - Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Not yet recruiting NCT03205644 - VX15/2503 in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04320888 - Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial Phase 2
Completed NCT00030667 - Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood Phase 2