Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT01082757
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2010-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients
Sponsor:
Merck KGaA, Darmstadt, Germany
Organization:
Study Overview
Official Title:
Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population.
Detailed 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).
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).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: