Metastatic Colorectal CancerCALLASNCT01651013
Observational Study on Treatment of Metastatic Colorectal Cancer and the Role of K-Ras
An observational study of Metastatic Colorectal Cancer, run by National Cancer Institute, Naples at 4 sites in Italy.
Trial summary
The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 500 participants
- Where
- 4 sitesItaly
- Study dates
- Oct 2010to Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at participating Institutes who are candidate for first-line treatment of metastatic colorectal cancer
Who may be able to join
- Histologic diagnosis colorectal carcinoma
- Metastatic disease
- Signed informed consent
Who cannot join
- Prior treatment of metastatic colorectal cancer
- Refusal or incapability of providing informed consent
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
A.O.G. Rummo
Benevento
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico
Naples
Ospedale Civile Umberto I
Nocera Inferiore
C:R.O. Regione Basilicata Ospedale Giustino Fortunato
Rionero in Vulture
About this study
Official title: Multicentered Observational Prospective Cohort Study on the Treatment of Metastatic Colorectal Cancer and the Role of Evaluating K-Ras
The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.
- Conditions
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metastatic colorectal cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients enrolled in a clinical trial
Measured: two years
percentage of patients who undergo K-Ras mutation study
Measured: 2 years
Percentage of patients with K-Ras mutation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R. V. Iaffaioli, M.D., Principal investigator, National Cancer Institute, NaplesG. Nasti, M.D., Principal investigator, National Cancer Institute, NaplesM. C. Piccirillo, M.D., Principal investigator, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651013
- Sponsor's protocol ID
- CALLAS
- Acronym
- CALLAS
- Status last verified
- Mar 2023
- First submitted
- 24 Jul 2012
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentered Observational Prospective Cohort Study on the Treatment of Metastatic Colorectal Cancer and the Role of Evaluating K-Ras
- ClinicalTrials.gov ID
- NCT01651013
- Acronym / sponsor ID
- CALLAS / CALLAS
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Jul 2012 (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.
The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic colorectal cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at participating Institutes who are candidate for first-line treatment of metastatic colorectal cancer
Key inclusion criteria (3 listed)
- Histologic diagnosis colorectal carcinoma
- Metastatic disease
- Signed informed consent
Key exclusion criteria (2 listed)
- Prior treatment of metastatic colorectal cancer
- Refusal or incapability of providing 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
percentage of patients enrolled in a clinical trial
Time frame: two years
percentage of patients who undergo K-Ras mutation study
Time frame: 2 years
Percentage of patients with K-Ras mutation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
R. V. Iaffaioli, M.D. principal investigator
National Cancer Institute, Naples
G. Nasti, M.D. principal investigator
National Cancer Institute, Naples
M. C. Piccirillo, M.D. principal investigator
National Cancer Institute, Naples
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by National Cancer Institute, Naples at 4 sites in Italy.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Results are not available in the source record.
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?
percentage of patients enrolled in a clinical trial (time frame: two years). The study lists 3 primary outcomes in all. 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 24 Mar 2023.