- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00972751
S9304A Study of Protein Expression in Tumor Tissue Samples From Patients With Stage II or Stage III Rectal Cancer Enrolled in Clinical Trial SWOG-9304
Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer
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 looking at protein expression in tumor tissue samples from patients with stage II or stage III rectal cancer enrolled in clinical trial SWOG-9304.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- Determine expression levels of thioredoxin-1 (Trx-1), thioredoxin-interacting protein (TXNIP), and hypoxia inducible factor-1 alpha (HIF-1α) in paraffin-embedded resected tumor tissue samples from patients with stage II or III rectal cancer enrolled in clinical trial SWOG-9304.
- Determine if there is a correlation between Trx-1 and TXNIP expression and HIF-1α expression.
- Correlate expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence.
- Determine interactions for patient age, performance status, and type of therapy received on clinical trial SWOG-9304.
OUTLINE: This is a multicenter study.
Paraffin-embedded resected tumor tissue samples are analyzed for protein expression levels (thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha) by tissue microarray and immunostaining.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the rectum
- Stage II or III disease
- No metastases
- Enrolled on clinical trial SWOG-9304
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha
Tidsramme: upon testing of specimens
|
upon testing of specimens
|
Correlation of expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence
Tidsramme: upon provision of expression to Statistical Center
|
upon provision of expression to Statistical Center
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Tomislav Dragovich, MD, PhD, University of Arizona
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000601255
- U10CA032102 (U.S. NIH-stipend/kontrakt)
- SWOG-9304A-ICSC (Annen identifikator: SWOG)
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