- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Role of copy-number alterations (CNAs) in the etiology of osteosarcoma
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Association between copy-number variations (CNVs) at chr7p14.1 and susceptibility to osteosarcoma
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Relationship between CNVs and tumor CNAs in osteosarcoma
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: David Malkin, MD, The Hospital for Sick Children
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AOST10B4
- COG-AOST10B4 (Annan identifierare: Children's Oncology Group)
- CDR0000674830 (Annan identifierare: Clinical Trials.gov)
- NCI-2011-02234 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
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