Colorectal NeoplasmsNCT01082757
Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients
An observational study of Colorectal Neoplasms, run by Merck KGaA, Darmstadt, Germany at 1 site in Argentina.
Trial summary
This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 1,524 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2009to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with histologicaly confirmed metastatic adenocarcinoma of the colon/rectum in Argentina
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients
This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population.
Read the 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).
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal neoplasms, metastasis, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene
Measured: Initial visit (Day 1) and subsequent visit till the end of the study
Secondary outcomes (1)
Subject and tumour characteristics and their association with KRAS mutational status
Measured: Initial visit (Day 1) and subsequent visit till the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJun 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Quimica Argentina S.A.I.C
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Quimica Argentina S.A.I.C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082757
- Sponsor's protocol ID
- EMR62202-513
- Status last verified
- Jul 2014
- First submitted
- 8 Mar 2010
- Last updated
- 31 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients
- ClinicalTrials.gov ID
- NCT01082757
- Acronym / sponsor ID
- EMR62202-513
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal neoplasms, metastasis, colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,524 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Quimica Argentina S.A.I.C
- Study start
- Jun 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with histologicaly confirmed metastatic adenocarcinoma of the colon/rectum in Argentina
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene
Time frame: Initial visit (Day 1) and subsequent visit till the end of the study
1 secondary outcome
Subject and tumour characteristics and their association with KRAS mutational status
Time frame: Initial visit (Day 1) and subsequent visit till the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Quimica Argentina S.A.I.C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Merck KGaA, Darmstadt, Germany at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene (time frame: Initial visit (Day 1) and subsequent visit till the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.