Metastatic Colorectal CancerPROMETCONCT03935763
Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
An observational study of Metastatic Colorectal Cancer, run by Servier Affaires Médicales at 18 sites in 18 countries.
Trial summary
A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective 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?
- observational disease study
- How many people
- 738 participants
- Where
- 18 sitesin 18 countries
- Study dates
- 8 Mar 2019to 30 Nov 2024
- 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: The target population will be adults with mCRC who are eligible and willing to receive subsequent treatment, having had two prior progressions since diagnosis of first metastasis.
Who may be able to join
- Age ≥ 18
- Diagnosis of mCRC
- Having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment.
Who cannot join
- Currently participating in an investigational clinical trial (thus it does not apply to observational cohort studies)
- Currently being treated for other cancer(s)
- Not having mental capacity and/or ability to participate in the study
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
Czechia1 site
University Hospital in Hradec Kralove Clinic of Oncology and Radiotherapy
Hradec Králové
Hungary1 site
Del-Pesti Centrum Korhaz OHII, Szent Laszlo Korhaz Telephely
Budapest
Ireland1 site
The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital
Dublin
Switzerland1 site
UniversitaetsSpital Zuerich (University Hospital Zurich)
Zurich
United Kingdom1 site
Cancer Research UK, Department of Medical Oncology-The Christie NHS Foundation Trust
Manchester
About this study
Official title: A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- observational disease study
- Keywords
- Real Worl Evidence
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational disease studyOther
observation of routine clinical practices in mCRC
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
metastatic Colorectal Cancer (mCRC) overall survival in real world setting
Measured: From date of randomization until the date of death from any cause, assessed up to 24 months months
Secondary outcomes (2)
Disease control measured by overall response
Overall response to treatment defined by complete and partial response, stable disease, progression of the disease
Measured: within 18 months from enrollment
Quality of life using Patients Reported Outcomes
Patients Reported Outcomes defined by a modified version of the questionnaire ACCEPTance by the Patients of their Treatment (ACCEPT)
Measured: within 18 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start8 Mar 2019
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 738 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Affaires Médicales
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935763
- Sponsor's protocol ID
- DIM-95005-001
- Other IDs
- EUPAS33865
- Acronym
- PROMETCO
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2019
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moss B, Goodall EA, Maravic Z, Marti F, Moss M, Rowley S, Sarrauste C, Wheatstone P. Real-world evidence research in metastatic colorectal cancer: raising awareness of the need for patient contributions. Future Oncol. 2023 Aug;19(26):1809-1821. doi: 10.2217/fon-2022-1253. Epub 2023 Jul 13.
PubMed 37439564Koopman M, Pinto C, Bodoky G, Garcia-Carbonero R, Marti FM, Bachet JB. Rationale and design of the PROMETCO study: a real-world, prospective, longitudinal cohort on the continuum of care of metastatic colorectal cancer from a clinical and patient perspective. Future Oncol. 2022 Apr;18(11):1313-1320. doi: 10.2217/fon-2021-1333. Epub 2022 Jan 19.
PubMed 35043682
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
- ClinicalTrials.gov ID
- NCT03935763
- Acronym / sponsor ID
- PROMETCO / DIM-95005-001
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Real Worl Evidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 738 participants (actual)
- Lead sponsor
- Servier Affaires MédicalesIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 2 May 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.
A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population will be adults with mCRC who are eligible and willing to receive subsequent treatment, having had two prior progressions since diagnosis of first metastasis.
Key inclusion criteria (3 listed)
- Age ≥ 18
- Diagnosis of mCRC
- Having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment.
Key exclusion criteria (3 listed)
- Currently participating in an investigational clinical trial (thus it does not apply to observational cohort studies)
- Currently being treated for other cancer(s)
- Not having mental capacity and/or ability to participate in the study
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 |
|---|---|---|
| observational disease studyobservation of routine clinical practices in mCRC | Other | – |
Primary outcome
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 months months
metastatic Colorectal Cancer (mCRC) overall survival in real world setting
2 secondary outcomes
Disease control measured by overall response
Time frame: within 18 months from enrollment
Quality of life using Patients Reported Outcomes
Time frame: within 18 months from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 37439564Moss B, Goodall EA, Maravic Z, Marti F, Moss M, Rowley S, Sarrauste C, Wheatstone P. Real-world evidence research in metastatic colorectal cancer: raising awareness of the need for patient contributions. Future Oncol. 2023 Aug;19(26):1809-1821. doi: 10.2217/fon-2022-1253. Epub 2023 Jul 13.
- Derived from this study: PubMed 35043682Koopman M, Pinto C, Bodoky G, Garcia-Carbonero R, Marti FM, Bachet JB. Rationale and design of the PROMETCO study: a real-world, prospective, longitudinal cohort on the continuum of care of metastatic colorectal cancer from a clinical and patient perspective. Future Oncol. 2022 Apr;18(11):1313-1320. doi: 10.2217/fon-2021-1333. Epub 2022 Jan 19.
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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.
18 sites in 18 countries: 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 Servier Affaires Médicales at 18 sites in 18 countries.
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 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Argentina, Austria, Belgium, Croatia, Czechia and 13 more countries. 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?
Overall survival (time frame: From date of randomization until the date of death from any cause, assessed up to 24 months months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935763, which also lists 2 linked publications.
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 22 Apr 2024.