Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients

Colorectal Neoplasms Clinical Trial

Official title:

Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082757
• Other study ID #: EMR62202-513
• Status: Completed
• Phase: N/A
• First received: March 8, 2010
• Last updated: July 30, 2014
• Start date: June 2009
• Est. completion date: August 2013

Study information

• Verified date: July 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Observational

Clinical Trial Summary

This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1524
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms

Locations

Country	Name	City	State
Argentina	Htal Vicente Lopez	Vicente Lopez

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Quimica Argentina S.A.I.C

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene		Initial visit (Day 1) and subsequent visit till the end of the study	No
Secondary	Subject and tumour characteristics and their association with KRAS mutational status		Initial visit (Day 1) and subsequent visit till the end of the study	No