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试验匹配程序模型配置

试验匹配程序包含内置的知识图,该图使用从 clinicaltrials.gov 中获取的试验,并定期更新。

将患者与试验匹配时,可以定义筛选器列表来查询一部分临床试验。 每个筛选器都可以基于 trial conditionstypesrecruitment statusessponsorsphasespurposesfacility nameslocationstrial IDs 进行定义。

  • 为同一筛选器类别指定多个值会生成一个试验集,该集是两个集的并集。

注意

本文中的示例基于 API 版本:2023-03-01-preview。 API 版本之间可能存在更改。 对于特定的 API 版本,请使用 REST API 参考来查看完整描述。

在以下配置中,模型会查询处于招募状态 recruitingnot yet recruiting 的试验。

"recruitmentStatuses": ["recruiting", "notYetRecruiting"]
  • 指定多个筛选器类别会生成一个试验集,该集是集的组合。 在以下情况下,只查询在伊利诺伊州招募的糖尿病试验。 将某个类别留空将不会限制该类别的试验。
"registryFilters": [
    {
        "conditions": [
            "Diabetes"
        ],
        "sources": [
            "clinicaltrials.gov"
        ],
        "facilityLocations": [
            {
                "country": "United States",
                "state": "IL"
            }
        ],
        "recruitmentStatuses": [
            "recruiting"
        ]
    }
]

证据

“证据”指示模型的输出是否应包括推理的证据。 默认值为 true。 对于模型认为患者没有资格参加的每个试验,模型将返回相关患者信息以及用于将患者排除在试验之外的资格条件。

{
    "type": "trialEligibility",
    "evidence": [
        {
            "eligibilityCriteriaEvidence": "Inclusion: Patient must have an Eastern Cooperative Oncology Group performance status of 0 or 1 The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.",
            "patientInfoEvidence": {
                "system": "http://www.nlm.nih.gov/research/umls",
                "code": "C1512162",
                "name": "Eastern Cooperative Oncology Group",
                "value": "2"
            }
        },
        {
            "eligibilityCriteriaEvidence": "Inclusion: Blood counts performed within 6 weeks prior to initiating chemotherapy must meet the following criteria: absolute neutrophil count must be greater than or equal 1200 / mm3 ;, platelet count must be greater than or equal 100,000 / mm3 ; and",
            "patientInfoEvidence": {
                "system": "http://www.nlm.nih.gov/research/umls",
                "code": "C0032181",
                "name": "Platelet Count measurement",
                "value": "75000"
            }
        }
    ],
    "id": "NCT03412643",
    "source": "clinicaltrials.gov",
    "value": "Ineligible",
}

详细

“详细”指示模型是否应返回试验信息。 默认值为 false。 如果设置为 True,则模型返回试验信息,包括 TitlePhaseTypeRecruitment statusSponsorsContactsFacilities

如果使用渐进匹配,则在显示试验结果之前,通常会在资格鉴定过程的最后阶段使用详细模式。

{
    "type": "trialEligibility",
    "id": "NCT03513939",
    "source": "clinicaltrials.gov",
    "metadata": {
        "phases": [
            "phase1",
            "phase2"
        ],
        "studyType": "interventional",
        "recruitmentStatus": "recruiting",
        "sponsors": [
            "Sernova Corp",
            "CTI Clinical Trial and Consulting Services",
            "Juvenile Diabetes Research Foundation",
            "University of Chicago"
        ],
        "contacts": [
            {
                "name": "Frank, MD, PhD",
                "email": "frank@surgery.uchicago.edu",
                "phone": "999-702-2447"
            }
        ],
        "facilities": [
            {
                "name": "University of Chicago Medical Center",
                "city": "Chicago",
                "state": "Illinois",
                "country": "United States"
            }
        ]
    },
    "value": "Eligible",
    "description": "A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation",
}

添加自定义试验

试验匹配程序可以采用自定义试验格式接收临床试验的资格条件。 服务用户应以文本形式提供自定义试验的资格条件部分,格式类似于 clinicaltrials.gov(相同缩进和结构)。 自定义试验可作为与患者匹配的唯一试验、自定义试验列表或 clinicaltrials.gov 知识图的补充提供。 若要提供自定义试验,试验匹配程序服务的输入应包含值为 customClinicalTrialRegisteryFilter.sources

{
   "Configuration":{
      "ClinicalTrials":{
         "CustomTrials":[
            {
               "Id":"CustomTrial1",
               "EligibilityCriteriaText":"INCLUSION CRITERIA:\n\n  1. Patients diagnosed with Diabetes\n\n2. patients diagnosed with cancer\n\nEXCLUSION CRITERIA:\n\n1. patients with RET gene alteration\n\n 2. patients taking Aspirin\n\n3. patients treated with Chemotherapy\n\n",
               "Demographics":{
                  "AcceptedSex":"female",
                  "acceptedAgeRange":{
                     "MinimumAge":{
                        "Unit":"Years",
                        "Value":0
                     },
                     "MaximumAge":{
                        "Unit":"Years",
                        "Value":100
                     }
                  }
               },
               "Metadata":{
                  "Phases":[
                     "Phase1"
                  ],
                  "StudyType":"Interventional",
                  "RecruitmentStatus":"Recruiting",
                  "Conditions":[
                     "Diabetes"
                  ],
                  "Sponsors":[
                     "sponsor1",
                     "sponsor2"
                  ],
                  "Contacts":[
                     {
                        "Name":"contact1",
                        "Email":"email1",
                        "Phone":"01"
                     },
                     {
                        "Name":"contact2",
                        "Email":"email2",
                        "Phone":"03"
                     }
                  ]
               }
            }
         ]
      },
      "Verbose":true,
      "IncludeEvidence":true
   },
   "Patients":[
      {
         "Id":"Patient1",
         "Info":{
            "Gender":"Female",
            "BirthDate":"2002-07-19T10:58:02.7500649+00:00",
            "ClinicalInfo":[
               {
                  "System":"http://www.nlm.nih.gov/research/umls",
                  "Code":"C0011849",
                  "Name":"Diabetes",
                  "Value":"True;EntityType:DIAGNOSIS"
               },
               {
                  "System":"http://www.nlm.nih.gov/research/umls",
                  "Code":"C0004057",
                  "Name":"aspirin",
                  "Value":"False;EntityType:MedicationName"
               }
            ]
         }
      }
   ]
}

后续步骤

若要开始使用试验匹配程序模型,请参阅