DNA Biomarkers in Samples From Patients With Osteosarcoma and Healthy Volunteers

Sarcoma Clinical Trial

Official title:

Search for Novel Genes in Osteosarcoma Revealed by Analysis of Tumour Copy-Number Alterations and Constitutional Copy-Number Variations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139983
• Other study ID #: AOST10B4
• Secondary ID: COG-AOST10B4CDR0
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: May 17, 2016
• Start date: April 2010

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood and 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.

PURPOSE: This research study is studying DNA biomarkers in samples from patients with osteosarcoma and healthy volunteers.

Description:

OBJECTIVES:

• To determine whether common copy-number alterations (CNAs) at chr7p14.1 arise de novo in osteosarcoma (OS) tumor DNA or whether they represent progression of constitutional copy-number variations (CNVs).

• To determine the association between constitutional CNVs at chr7p14.1 and susceptibility to OS.

• To determine how CNVs translate into CNAs in tumor DNA samples from patients with OS.

OUTLINE: RNA and DNA samples from banked blood and paired tumor tissue, plus samples from healthy controls, are analyzed for common copy-number alterations and constitutional copy-number variations (CNVs) at chr7p14.1 by microarray, q-PCR, RT-PCR, and FISH. Osteosarcoma predisposing CNVs results are then compared among cases versus healthy controls.

Clinical information associated with each osteosarcoma sample (i.e., gender, age of diagnosis, tumor site, tumor type and grade, presence of metastases at time of diagnosis, response to chemotherapy, event-free survival, and overall survival) is also collected, if available.

PROJECTED ACCRUAL: A total of 243 samples from patients with osteosarcoma and 80 samples from healthy controls will be accrued to this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

• Diagnosis of osteosarcoma (OS) and meets 1 of the following criteria:

• Original 153 OS samples, including paired germline and tumor DNA

• Additional samples from 90 patients with OS:

• Blood samples

• Germline DNA

• Paired tumor biopsy tissue (not from resection) obtained before systemic chemotherapy

• Healthy controls, age- and gender-matched

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteosarcoma
• Sarcoma

Intervention

Genetic:
• DNA analysis

• RNA analysis

• fluorescence in situ hybridization

• microarray analysis

• polymerase chain reaction

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of copy-number alterations (CNAs) in the etiology of osteosarcoma			No
Primary	Association between copy-number variations (CNVs) at chr7p14.1 and susceptibility to osteosarcoma			No
Primary	Relationship between CNVs and tumor CNAs in osteosarcoma			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database