- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01828918
Biomarkers for the Early Diagnosis, Prediction, Prognosis for Colorectal Cancers
Kaohsiung Medical University Hospital
Studieoversikt
Detaljert beskrivelse
Colorectal cancer (CRC) is one of the most frequent malignancies and is also the third major cause of cancer-related death in Taiwan, with over 11,000 new cases of CRC were diagnosed and more than 4,400 Taiwanese died from CRC in 2008 (Department of Health). CRC is regarded as the accumulation of acquired genetic and epigenetic changes causing disorders in cell growth, differentiation and apoptosis resulting in transformation of normal colonic epithelium to colon adenocarcinoma.
Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognosis, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic therapy are the most important future clinical applications. The investigators divide the current project into three dimensions to include all the biomarkers related to diagnostic, prognostic and predictive roles for the potential clinical implication. Sub-project 1: prognostic validation and economic evaluation of biochips/biomarkers. Sub-project 2: evaluation of biomarkers for tailored therapy. Sub-project 3: identification and validation of novel biomarkers for early detection. After accomplishment of three sub-projects, a comprehensive network including early diagnostic, prognostic and predictive biomarkers/biochips for high-risk screening, postoperative surveillance, therapeutic strategies of CRC patients will be formed.
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Kaohsiung, Taiwan, 807
- Rekruttering
- Kaohsiung Medical University Hospital
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Ta kontakt med:
- Jaw-Yuan Wang, Professor
- Telefonnummer: 5583 +886-7-3121101
- E-post: cy614112@ms14.hinet.net
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Hovedetterforsker:
- Jaw-Yuan Wang, Professor
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age > 18 y/o
- Histological / pathologic and image study proved colorectal cancer
- Patients with adequate tissue for biomarkers analysis
- Patients voluntary sign informed consent
Exclusion Criteria:
- Patients who are not met with either one of items which mentioned above.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: early recurrence
find the postoperative early relapse out
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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postoperative early recurrence
Tidsramme: within 12 months postoperation
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within 12 months postoperation
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KMUH-IRB-2012-03-02 (II)
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