ID
2613
Beskrivning
Registration Worksheet (RW) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B123165F-AFDA-4C3D-E034-0003BA12F5E7
Länk
Nyckelord
Versioner (1)
- 2012-09-19 2012-09-19 -
Uppladdad den
19 september 2012
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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Melanoma (Skin) null Registration - Registration Worksheet (RW) - 2073173v3.0
Instructions: Please fill-in the appropriate circle for each Inclusion and Exclusion Criterion. Each criterion must be marked and all protocol criteria have to be met prior to registering the patient.
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Inclusion Criteria:
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Patientmustbe>18yearsofageatstudyregistration.
Datatyp
text
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PatientmusthaveprimaryinvasivecutaneousmelanomaofBreslowthickness2mmorgreater,asdeterminedbydiagnosticbiopsy(excisional,punch,orshave),within90dayspriortoregistration.
Datatyp
text
Beskrivning
Historyandphysicalexamination.Patientwithsigns,symptoms,orphysicalexamfindingssuspiciousformetastaticdiseasemustundergofurtherevaluationinordertomaintaineligibility(seeRecommendationsforEvaluationofPotentialMetastaticDiseas
Datatyp
text
Beskrivning
P/AandlateralchestX-ray(CXR).PatientwithabnormalCXRfindingssuspiciousformetastaticdiseasemusthaveanegativeorequivocalchestCTorFDG-PETinordertomaintaineligibility.
Datatyp
text
Beskrivning
Serumlactatedehydrogenase(LDH)level.PatientwithanelevatedserumLDH,definedasaserumlevelgreaterthantheupperlimitofinstitutionalnormal,musthaveanegativeorequivocalCTscan,MRI,ultrasound,orFDG-PEToftheabdomeninordertom
Datatyp
text
Beskrivning
Patientorthepatient?slegallyacceptablerepresentativemustprovideasignedanddatedwritteninformedconsentpriortoregistrationandanystudy-relatedprocedures.
Datatyp
text
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AsurvivorofpriorcanceriseligibleprovidedthatALLofthefollowingcriteriaaremetanddocumented:
Datatyp
text
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Exclusion Criteria:
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Patienthasprimarymelanomaofmucosalorocularorigin,orlocatedonafingerdistaltothemetacarpophalangealjoint,onatoedistaltothemetatarsophalangealjoint,onthetipofthenose,ontheeyelidsorontheear.
Datatyp
text
Beskrivning
Patienthasahistoryofanon-indexprimarymelanomaofBreslowthickness1mmorgreater,oranypriormelanomawithahistoryoflymphatic,in-transit,ordistantmetastases.
Datatyp
text
Beskrivning
Patienthasclinicalevidenceofregionallymphnodemetastasesasevidencedbysuspiciouspalpableregionallymphadenopathyorbiopsy.
Datatyp
text
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Patienthascutaneousin-transitmetastases(morethan2cmfromtheprimarytumor)orgrossclinicalevidenceofsatellitosis(lessthan2cmfromprimarytumor).
Datatyp
text
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Patientpreviouslyhashadawideexcisionofamelanomaatthesiteoftheindexlesion.
Datatyp
text
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Patienthashadpriorlymphaticsurgery(i.e.,lymphnodedissectionsoropenlymphnodebiopsies,includingsentinellymphnodebiopsies),inthearea(s)ofpotentiallymphaticdrainageoftheindexmelanoma.
Datatyp
text
Beskrivning
Patienthasclinicalorradiographicevidenceofprobablemetastaticdisease.
Datatyp
text
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ACOSOGPatientEligibilityInd-2
Datatyp
text
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus ObjectClass
- C19712
- UMLS 2011AA ObjectClass
- C1515944
- NCI Thesaurus Property
- C25171
- UMLS 2011AA Property
- C0013893
Beskrivning
Randomization
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Indicatearmassigned:
Datatyp
text
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BiopsyDate
Datatyp
date
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AssessmentDate
Datatyp
date
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ChestX-RayAssessmentDate
Datatyp
date
Beskrivning
Lab,Hematology,SampleCollectionDate
Datatyp
date
Beskrivning
IsLDHgreaterthanupperlimitofinstitutionalnorm:
Datatyp
text
Alias
- NCI Thesaurus ValueDomain
- C38148
- UMLS 2011AA ValueDomain
- C1512699
Beskrivning
Stratification
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BreslowDepth
Datatyp
double
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UlcerationInd
Datatyp
text
Beskrivning
Lesion,AnatomicSite
Datatyp
text
Beskrivning
CompletedBy
Datatyp
text
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FormCompletionDate,Original
Datatyp
date
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Ccrr Module For Registration Worksheet (rw)
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Pt.ID
Datatyp
text
Beskrivning
InstitutionNo.
Datatyp
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS 2011AA ValueDomain
- C0237753
Beskrivning
PatientName
Datatyp
text
Beskrivning
InstitutionName
Datatyp
text
Beskrivning
RegistrationDate
Datatyp
text
Beskrivning
PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
Datatyp
text
Alias
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus ObjectClass
- C16124
- UMLS 2011AA ObjectClass
- C1514463
- NCI Thesaurus Property
- C19712
- UMLS 2011AA Property
- C1515944
- NCI Metathesaurus Property
- CL238692
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
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Instructions: Please fill-in the appropriate circle for each Inclusion and Exclusion Criterion. Each criterion must be marked and all protocol criteria have to be met prior to registering the patient.
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