Metastatic Colorectal CancerNCT04031625
Metastatic Colorectal Cancer Database
An observational study of Metastatic Colorectal Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management in Centre Georges Francois Leclerc, Dijon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Metastatic Colorectal Cancer Database
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2012to Nov 2022
- 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: Regular clinical metastatic colorectal patient management in Centre Georges François Leclerc, Dijon
Who may be able to join
- Metastatic colorectal cancer
- Age >= 18
Who cannot join
- Non metastatic colorectal cancer
- Objection to the use of medical data records
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Methodology, Biostatistics and Data Management
Dijon
AURELIE BERTAUT, MD, PhD, +33 3 80 73 77 84, ABertaut@cgfl.fr
About this study
Official title: Prospective and Retrospective Metastatic Colorectal Cancer Database
The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management in Centre Georges Francois Leclerc, Dijon.
Read the detailed description
The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution, ...). This database allows easy access to information in a centralized and structured way. This cohort is used to gather insights for research purposes.
All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Metastatic Colorectal Cancer Database
- Keywords
- 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.
Metastatic Colorectal Cancer DatabaseOther
Metastatic Colorectal Cancer Database
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Colorectal Cancer | Not described Receives: Other: Metastatic Colorectal Cancer Database |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Overall survival and evolution over years
Measured: 2 years
Secondary outcomes (1)
Collection of patient and treatment characteristics
Collection of patient and treatment characteristics over years, to set up prospective and retrospective studies
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 posted24 Jul 2019
- Study start26 Nov 2012
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031625
- Sponsor's protocol ID
- AB2012CR
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 24 Jul 2019
- 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective Metastatic Colorectal Cancer Database
- ClinicalTrials.gov ID
- NCT04031625
- Acronym / sponsor ID
- AB2012CR
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 26 Nov 2012 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 24 Jul 2019 (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 metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management in Centre Georges Francois Leclerc, Dijon.
Detailed description
The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution, ...). This database allows easy access to information in a centralized and structured way. This cohort is used to gather insights for research purposes.
All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Colorectal Cancer | – | Other: Metastatic Colorectal Cancer Database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Regular clinical metastatic colorectal patient management in Centre Georges François Leclerc, Dijon
Key inclusion criteria (2 listed)
- Metastatic colorectal cancer
- Age >= 18
Key exclusion criteria (2 listed)
- Non metastatic colorectal cancer
- Objection to the use of medical data records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metastatic Colorectal Cancer DatabaseMetastatic Colorectal Cancer Database | Other | Metastatic Colorectal Cancer |
Primary outcome
Patient survival
Time frame: 2 years
Overall survival and evolution over years
1 secondary outcome
Collection of patient and treatment characteristics
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 Jul 2019.
- 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.
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 Centre Georges Francois Leclerc at 1 site in France.
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 2 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 Jul 2019. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: 2 years). 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 Jul 2019.