protocolSection identificationModule nctId: NCT06263530, orgStudyIdInfo id: NU22-03-00182, briefTitle: Prognostic Significance of ctDNA in HL, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-02, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Interni hematologicka klinika FNKV, class: NETWORK, collaborators name: Charles University, Czech Republic, collaborators name: General University Hospital, Prague, collaborators name: University Hospital Olomouc, collaborators name: University Hospital Hradec Kralove, collaborators name: University Hospital, Motol, descriptionModule briefSummary: Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy., conditionsModule conditions: Prognostic Cancer Model, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identification of tumor specific mutation profiles at dg. of HL based on ctDNA, primaryOutcomes measure: Quantitative analysis of ctDNA level during the first-line chemotherapy, primaryOutcomes measure: Identification of tumor specific mutation profiles at relapse of classical HL, secondaryOutcomes measure: In vitro functional characterization of identified DNA variants and/or mutations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Hradec Kralove, status: RECRUITING, city: Hradec Kralove, zip: 50005, country: Czechia, contacts name: Alice Sykorova, M.D., Ph.D., role: CONTACT, phone: +420495 832 866, email: alice.sykorova@fnhk.cz, geoPoint lat: 50.20923, lon: 15.83277, locations facility: University Hospital Olomouc, status: RECRUITING, city: Olomouc, zip: 77520, country: Czechia, contacts name: Vit Prochazka, prof. M.D., role: CONTACT, phone: +420588 442 878, email: prochazv@fnol.cz, geoPoint lat: 49.59552, lon: 17.25175, locations facility: University Hospital Kralovske Vinohrady, status: RECRUITING, city: Praha, zip: 10034, country: Czechia, contacts name: Heidi Mocikova, M.D., Ph.D., role: CONTACT, phone: +420267163554, email: heidi.mocikova@fnkv.cz, contacts name: Katerina Klaskova, Ing., role: CONTACT, phone: +420267162880, email: katerina.klaskova@fnkv.cz, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Charles University, status: ACTIVE_NOT_RECRUITING, city: Praha, zip: 12108, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: General University Hospital, status: RECRUITING, city: Praha, zip: 12808, country: Czechia, contacts name: Jan Koren, M.D., role: CONTACT, phone: +420224962541, email: jan.koren@vfn.cz, geoPoint lat: 50.08804, lon: 14.42076, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-30, uploadDate: 2024-02-07T11:30, filename: Prot_SAP_000.pdf, size: 329948, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-30, uploadDate: 2024-02-07T11:43, filename: ICF_001.pdf, size: 82316, hasResults: False