- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01082757
Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients
Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This is an observational, prospective, non-interventional, single arm, non-comparative, open label, multi-centric, multi-stage study to record the prevalence of KRAS mutations in the Argentine mCRC population. The study is planned to be conducted in 150 centres (50 in each of 3 stages of four months each, enrolling 500 subjects in each stage). Total of subjects: 1500. Demographic information, complete medical history and tumour history related data will be captured in the first visit and if any information is missing, then only another visit will be scheduled. Data captured will be analysed and presented using statistical tools.
OBJECTIVES:
Primary objective:
- To record the prevalence of KRAS mutations in the Argentine mCRC population.
Secondary objective:
- To record and evaluate certain subject and tumour characteristics for association with KRAS mutational status (country, gender, age, performance status, body mass index (BMI), ethnic origin, personal and family history of malignancy, personal and family history of familial polyposis coli, smoking status, exercise, diet, tumour characteristics/location, site of origin of the tissue sample sent for KRAS testing, first line therapy chosen).
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Vicente Lopez, Argentina
- Htal Vicente Lopez
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Subjects who have signed written informed consent before any study-related procedure
- Subjects with histologically confirmed adenocarcinoma of the colon/ rectum, T1-4 N0-2 M1 or rT1-4 N0-2 M1
- Subjects with age above 21 years
- Subjects willing to provide information required by protocol
- No previous systemic treatment for mCRC
Exclusion Criteria:
- Subjects with known pregnancy
- Subjects with previous systemic therapy for mCRC
- Subjects with active infection or any other serious condition which, in the investigator´s mind, may render the subject ineligible for the study
- Subjects with medical or psychological condition, which, in the opinion of the investigator, would not permit the subject to sign meaningful informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene
Tidsramme: Initial visit (Day 1) and subsequent visit till the end of the study
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Initial visit (Day 1) and subsequent visit till the end of the study
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Subject and tumour characteristics and their association with KRAS mutational status
Tidsramme: Initial visit (Day 1) and subsequent visit till the end of the study
|
Initial visit (Day 1) and subsequent visit till the end of the study
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Medical Director, Merck Quimica Argentina S.A.I.C
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EMR62202-513
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