German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
{
"resourceType" : "ResearchStudy",
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"meta" : {
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🔗 "https://www.vision-zero-oncology.de/fhir/StructureDefinition/clinical-study"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"ExampleStudyRAAINBOW\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ResearchStudy "ExampleStudyRAAINBOW" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-clinical-study.html\">Profile Clinical Study</a></p></div><p><b>identifier</b>: id:\u00a0NCT03240627</p><p><b>title</b>: Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.</p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: Treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-prim-purp-type.html\">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 2/Phase 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-2-phase-3)</span></p><p><b>category</b>: Interventional Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C98388)</span>, Randomized Controlled Clinical Trial <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C46079)</span>, Double Blind Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C15228)</span>, Unequal Randomization <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C142743)</span></p><p><b>focus</b>: Pharmacologic Substance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C1909)</span></p><p><b>condition</b>: Alopecia areata (disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#68225006)</span></p><p><b>location</b>: Germany <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#DE)</span>, France <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#FR)</span></p><p><b>period</b>: 2018-03-01 --> 2022-03-17</p><p><b>principalInvestigator</b>: <a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Practitioner/example\">Practitioner/example</a></p><p><b>site</b>: </p><ul><li><a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Charite-dermatology\">Organization/Charite-dermatology</a></li><li><a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Sabouraud-Center\">Organization/Sabouraud-Center</a></li><li><a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Diagnostic-consulting-center-XXIV-Sofia\">Organization/Diagnostic-consulting-center-XXIV-Sofia</a></li><li><a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/SC-Centrul-Medical-Sana-SRL\">Organization/SC-Centrul-Medical-Sana-SRL</a></li></ul><blockquote><p><b>arm</b></p><p><b>name</b>: Experimental: LH-8 cutaneous solution</p><p><b>type</b>: Investigational Arm <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C174266)</span></p><p><b>description</b>: LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo Comparator: Placebo cutaneous solution</p><p><b>type</b>: Control Arm <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C174226)</span></p><p><b>description</b>: Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp</p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. [ Time Frame: 24 weeks treatment ] Visual assessment and global standardised scalp photographs for SALT evaluation.</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Adverse events [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: General physical examination findings, including irritation of eyes and skin [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Visual assessment and global standardised scalp photographs for SALT evaluation. [ Time Frame: After 12 and 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.)</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of the rate of spontaneous hair regrowth. [ Time Frame: For 6-12 months ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation).</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote></div>"
},
"identifier" : [
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"value" : "NCT03240627"
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],
"title" : "Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.",
"status" : "completed",
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{
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"location" : [
{
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{
"coding" : [
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"period" : {
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},
"description" : "LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp"
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{
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]
},
"description" : "Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp"
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],
"objective" : [
{
"name" : "Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. [ Time Frame: 24 weeks treatment ] Visual assessment and global standardised scalp photographs for SALT evaluation.",
"type" : {
"coding" : [
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{
"name" : "Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]",
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{
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{
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{
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},
{
"name" : "Visual assessment and global standardised scalp photographs for SALT evaluation. [ Time Frame: After 12 and 24 weeks treatment ]",
"type" : {
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},
{
"name" : "Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.)",
"type" : {
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},
{
"name" : "Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. [ Time Frame: 24 weeks treatment ]",
"type" : {
"coding" : [
{
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}
},
{
"name" : "Assessment of the rate of spontaneous hair regrowth. [ Time Frame: For 6-12 months ]",
"type" : {
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{
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"code" : "secondary"
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},
{
"name" : "Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation).",
"type" : {
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}
},
{
"name" : "Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores. [ Time Frame: 48 weeks ]",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
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]
}
},
{
"name" : "Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]",
"type" : {
"coding" : [
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"code" : "secondary"
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}
},
{
"name" : "Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5. [ Time Frame: 48 weeks ]",
"type" : {
"coding" : [
{
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"code" : "secondary"
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},
{
"name" : "Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary"
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]
}
},
{
"name" : "Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]",
"type" : {
"coding" : [
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}
]
}
IG © 2021+ Berlin Institute of Health at Charité (BIH). Package gold#0.1.0 based on FHIR 4.0.1. Generated 2023-12-13
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QA Report