Metastatic Colorectal CancerRWD-mCRC-001NCT04757311
Metastatic Colorectal Cancer. Real-World Data Analysis.
An observational study of Metastatic Colorectal Cancer, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 1,750 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Oct 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed within 3-years period before March 2019 will be included.
Who may be able to join
- Patients who have been histologically diagnosed with mCRC
- Patients over the age of 18
- Patients receiving at least a cycle systemic treatment for metastatic disease
- RAS wild type patients
- Patients who has demographic, histopathological and clinical information
Who cannot join
- Patients diagnosed as mCRC but only referred to BSC
- Patients with RAS mutation
- Patients who were included in any clinical trial except standard treatments during their treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Hospital
Istanbul, 81450
About this study
Official title: The Treatment Choices, Duration and Outcomes in Patients With Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis
The Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis
Read the detailed description
In this study, with the given rationale is to reveal treatment approaches, survival data, side effect profile and their management in our country in RAS WT mCRC patients by means of the real-world data collection.
- 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 Patients | All RAS wild type metastatic colorectal cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of use anti-EGFR agents
The anti-EGFR agent selection
Measured: throughout of treatment, 3 years
Progression Free Survival (PFS)
PFS three years after initiation of treatment with anti-EGFR agents
Measured: 3 years treatment
Secondary outcomes (1)
Advers events
Advers event of anti EGFR is defined as any untoward or unfavourable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with the patient's participation. The CTCAE v.4.0 will use in this research.
Measured: throughout of treatment, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Aug 2020
- Primary completion30 Apr 2021
- Study completion1 Oct 2021
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
- Case only
- Time perspective
- Other
- Enrolment
- 1,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Gumus, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757311
- Sponsor's protocol ID
- ONCO-COLON-TURKEY STUDY
- Acronym
- RWD-mCRC-001
- Status last verified
- Oct 2021
- First submitted
- 30 Aug 2020
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Choices, Duration and Outcomes in Patients With Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis
- ClinicalTrials.gov ID
- NCT04757311
- Acronym / sponsor ID
- RWD-mCRC-001 / ONCO-COLON-TURKEY STUDY
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,750 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- 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 Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis
Detailed description
In this study, with the given rationale is to reveal treatment approaches, survival data, side effect profile and their management in our country in RAS WT mCRC patients by means of the real-world data collection.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Colorectal Cancer Patients | – | –All RAS wild type metastatic colorectal cancer patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed within 3-years period before March 2019 will be included.
Key inclusion criteria (5 listed)
- Patients who have been histologically diagnosed with mCRC
- Patients over the age of 18
- Patients receiving at least a cycle systemic treatment for metastatic disease
- RAS wild type patients
- Patients who has demographic, histopathological and clinical information
Key exclusion criteria (3 listed)
- Patients diagnosed as mCRC but only referred to BSC
- Patients with RAS mutation
- Patients who were included in any clinical trial except standard treatments during their treatment
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 use anti-EGFR agents
Time frame: throughout of treatment, 3 years
The anti-EGFR agent selection
Progression Free Survival (PFS)
Time frame: 3 years treatment
PFS three years after initiation of treatment with anti-EGFR agents
1 secondary outcome
Advers events
Time frame: throughout of treatment, 3 years
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 27 Oct 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metastatic Colorectal Cancer, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 3 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 27 Oct 2021. 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 Turkey (Türkiye). 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?
Percentage of use anti-EGFR agents (time frame: throughout of treatment, 3 years). The study lists 2 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 27 Oct 2021.