Clinical trial · Observational
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
NCT03935763CI-TRIAL-00076352PROMETCOunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| observational disease study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From date of randomization until the date of death from any cause, assessed up to 24 months months
- description
- metastatic Colorectal Cancer (mCRC) overall survival in real world setting
Secondary outcomes (2)
- measure
- Disease control measured by overall response
- timeFrame
- within 18 months from enrollment
- description
- Overall response to treatment defined by complete and partial response, stable disease, progression of the disease
- measure
- Quality of life using Patients Reported Outcomes
- timeFrame
- within 18 months from enrollment
- description
- Patients Reported Outcomes defined by a modified version of the questionnaire ACCEPTance by the Patients of their Treatment (ACCEPT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Diagnosis of mCRC * Having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment. Exclusion Criteria: * 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
References
Publications (2)
- DERIVEDMoss 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. PMID 37439564
- DERIVEDKoopman 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. PMID 35043682