{
  "id": "ctis:2024-520288-15-00",
  "euct": "2024-520288-15-00",
  "title": "RAXO trial - A population-based prospective study to evaluate clinical behaviour, resectability and survival in metastatic colorectal cancer patients in Finland",
  "publicTitle": "RAXO trial - A population-based prospective study to evaluate clinical behaviour, resectability and survival in metastatic colorectal cancer patients in Finland",
  "fullTitle": "RAXO trial - A population-based prospective study to evaluate clinical behaviour, resectability and survival in metastatic colorectal cancer patients in Finland",
  "shortTitle": null,
  "status": "Authorised",
  "statusCode": "4",
  "startDateEU": "2025-01-25",
  "decisionDate": "2025-01-24T12:17:33.004",
  "publishDate": "2025-12-20T02:42:01.549903918",
  "trialRegion": "EEA",
  "trialRegionCode": "1",
  "medicalConditions": [
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      "name": "Metastatic or locally advanced inoperable colorectal cancer",
      "rareDisease": false
    }
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  "therapeuticAreas": [
    {
      "code": "4",
      "name": "Diseases [C] - Neoplasms [C04]"
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  ],
  "trialCategory": {
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    "categoryCode": "3",
    "lowIntervention": true
  },
  "duration": {
    "estimatedRecruitmentStartDate": "2011-09-12",
    "estimatedEndDate": "2035-12-31",
    "estimatedGlobalEndDate": null
  },
  "countries": [
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      "name": "Finland",
      "publicStatusCode": "4",
      "firstDecisionDate": "2025-01-24T12:17:33.004",
      "lastDecisionDate": "2025-12-19T10:50:00.614",
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      "submissionDate": "2025-11-01",
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          "decisionDate": "2025-01-24",
          "firstDecisionDate": "2025-01-24",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-12-12",
          "reportingStatusCode": "Authorised",
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  "evidence": [
    {
      "id": "evidence:fb77564ec782d2bedf71ccbb",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[2].secondaryObjective",
      "term": "machine learning",
      "snippet": "• To radiologically or with machine learning from scans or reports assess tumour sites ,density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria"
    }
  ],
  "official": {
    "retrieveUrl": "https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-520288-15-00",
    "publicUrl": "https://euclinicaltrials.eu/ctis-public/view/2024-520288-15-00?lang=en"
  },
  "slug": "2024-520288-15-00",
  "firstObservedAt": "2026-07-23T11:19:41.794Z",
  "lastObservedAt": "2026-07-23T13:03:56.000Z",
  "dateModified": "2026-07-23",
  "materialFingerprint": "fe6cd1a730192ff00af92e5bccb9cc1fcdf8a866601ae38ca33484d7295ad3b0"
}
