- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Tomislav Dragovich, MD, PhD, University of Arizona
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000601255
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- SWOG-9304A-ICSC (Anden identifikator: SWOG)
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