Clinical trial · Observational
CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)
- 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)
This study will collect data on Canadian cancer patients that have uncommon/rare changes in their tumours, such as alterations/rearrangements in the genetic material inside cells - known as deoxyribonucleic acid, or DNA, which acts as a map and gives directions to the cells on how to make other substances the body needs - because some of these changes have been found to respond to different drugs that help to stop the cancer. These rare changes occur in genes such as but not limited to ALK, EGFR, ROS1, BRAF, and NTRK which have targeted drugs in a family known as tyrosine kinase inhibitors (TKIs), and KRAS G12C mutation, which now has a targeted inhibitor drug therapy for patients with non small cell lung cancer (NSCLC). The goals for the study are to compare the natural history of such cancers and the treatment outcomes, including toxicities and patient-reported outcomes, for the different therapies.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer, Therapy-Related | Therapy-Related Malignant Neoplasm | ALIAS | 0.90 |
| Gene Fusion | — | UNRESOLVED | — |
| Genetic Alteration | — | UNRESOLVED | — |
| Malignancies Multiple | — | UNRESOLVED | — |
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
| Molecular Sequence Variation | — | UNRESOLVED | — |
| Ras (Kras or Nras) Gene Mutation | — | UNRESOLVED | — |
| Receptor Tyrosine Kinase Gene Mutation |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents. | Drug | — | UNRESOLVED |
| Patient-reported outcomes (PROs) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Prospective
- description
- Living cancer patients with histologically confirmed rare molecular alterations in their tumours, such as in ALK, EGFR, ROS1, BRAF, and KRAS G12C from participating sites/cancer centres across Canada.
- interventionNames
- Drug: Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.
- Other: Patient-reported outcomes (PROs)
- label
- Retrospective
- description
- Deceased cancer patients who had histologically confirmed rare molecular alterations in their tumours, such as in ALK, EGFR, ROS1, BRAF, and KRAS G12C from participating sites/cancer centres across Canada.
- interventionNames
- Drug: Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.
- label
- Comparator group
- description
- All cancer patients without rare molecular alterations in their solid tumours. This group will be established in order to determine baseline characteristics and outcomes, including treatment outcomes, of more standard treatments such as systemic chemotherapy or immunotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years at cancer diagnosis * Diagnosed with malignant tumour(s) with molecular testing completed that identified rare molecular alterations * Accessible/available molecular testing reports/documentation to confirm type(s) of molecular alteration(s) (resulting from the conduct of polymerase chain reaction \[PCR\] based next generation sequencing \[NGS\], immunohistochemistry \[IHC\], fluorescence in situ hybridization \[FISH\], liquid biopsy) * Canadian resident received follow-up for cancer care in Canada or is currently receiving/planning follow-up for cancer care to occur in Canada at time of enrollment Exclusion Criteria: * Previous refusal of the deceased patient, when living, to enroll in this study or patient approached for this study is unable to provide informed consent
References
Publications (0)
Data not yet available