- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01139983
DNA Biomarkers in Samples From Patients With Osteosarcoma and Healthy Volunteers
Search for Novel Genes in Osteosarcoma Revealed by Analysis of Tumour Copy-Number Alterations and Constitutional Copy-Number Variations
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
|---|
|
Role of copy-number alterations (CNAs) in the etiology of osteosarcoma
|
|
Association between copy-number variations (CNVs) at chr7p14.1 and susceptibility to osteosarcoma
|
|
Relationship between CNVs and tumor CNAs in osteosarcoma
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: David Malkin, MD, The Hospital for Sick Children
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AOST10B4
- COG-AOST10B4 (Andere identificatie: Children's Oncology Group)
- CDR0000674830 (Andere identificatie: Clinical Trials.gov)
- NCI-2011-02234 (Register-ID: CTRP (Clinical Trial Reporting Program))
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .