ID
2613
Beschrijving
Registration Worksheet (RW) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B123165F-AFDA-4C3D-E034-0003BA12F5E7
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Versies (1)
- 19-09-12 19-09-12 -
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19 september 2012
DOI
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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.
Beschrijving
Inclusion Criteria:
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Patientmustbe>18yearsofageatstudyregistration.
Datatype
text
Beschrijving
PatientmusthaveprimaryinvasivecutaneousmelanomaofBreslowthickness2mmorgreater,asdeterminedbydiagnosticbiopsy(excisional,punch,orshave),within90dayspriortoregistration.
Datatype
text
Beschrijving
Historyandphysicalexamination.Patientwithsigns,symptoms,orphysicalexamfindingssuspiciousformetastaticdiseasemustundergofurtherevaluationinordertomaintaineligibility(seeRecommendationsforEvaluationofPotentialMetastaticDiseas
Datatype
text
Beschrijving
P/AandlateralchestX-ray(CXR).PatientwithabnormalCXRfindingssuspiciousformetastaticdiseasemusthaveanegativeorequivocalchestCTorFDG-PETinordertomaintaineligibility.
Datatype
text
Beschrijving
Serumlactatedehydrogenase(LDH)level.PatientwithanelevatedserumLDH,definedasaserumlevelgreaterthantheupperlimitofinstitutionalnormal,musthaveanegativeorequivocalCTscan,MRI,ultrasound,orFDG-PEToftheabdomeninordertom
Datatype
text
Beschrijving
Patientorthepatient?slegallyacceptablerepresentativemustprovideasignedanddatedwritteninformedconsentpriortoregistrationandanystudy-relatedprocedures.
Datatype
text
Beschrijving
AsurvivorofpriorcanceriseligibleprovidedthatALLofthefollowingcriteriaaremetanddocumented:
Datatype
text
Beschrijving
Exclusion Criteria:
Beschrijving
Patienthasprimarymelanomaofmucosalorocularorigin,orlocatedonafingerdistaltothemetacarpophalangealjoint,onatoedistaltothemetatarsophalangealjoint,onthetipofthenose,ontheeyelidsorontheear.
Datatype
text
Beschrijving
Patienthasahistoryofanon-indexprimarymelanomaofBreslowthickness1mmorgreater,oranypriormelanomawithahistoryoflymphatic,in-transit,ordistantmetastases.
Datatype
text
Beschrijving
Patienthasclinicalevidenceofregionallymphnodemetastasesasevidencedbysuspiciouspalpableregionallymphadenopathyorbiopsy.
Datatype
text
Beschrijving
Patienthascutaneousin-transitmetastases(morethan2cmfromtheprimarytumor)orgrossclinicalevidenceofsatellitosis(lessthan2cmfromprimarytumor).
Datatype
text
Beschrijving
Patientpreviouslyhashadawideexcisionofamelanomaatthesiteoftheindexlesion.
Datatype
text
Beschrijving
Patienthashadpriorlymphaticsurgery(i.e.,lymphnodedissectionsoropenlymphnodebiopsies,includingsentinellymphnodebiopsies),inthearea(s)ofpotentiallymphaticdrainageoftheindexmelanoma.
Datatype
text
Beschrijving
Patienthasclinicalorradiographicevidenceofprobablemetastaticdisease.
Datatype
text
Beschrijving
ACOSOGPatientEligibilityInd-2
Datatype
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
Beschrijving
Randomization
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Indicatearmassigned:
Datatype
text
Beschrijving
BiopsyDate
Datatype
date
Beschrijving
AssessmentDate
Datatype
date
Beschrijving
ChestX-RayAssessmentDate
Datatype
date
Beschrijving
Lab,Hematology,SampleCollectionDate
Datatype
date
Beschrijving
IsLDHgreaterthanupperlimitofinstitutionalnorm:
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C38148
- UMLS 2011AA ValueDomain
- C1512699
Beschrijving
Stratification
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BreslowDepth
Datatype
double
Beschrijving
UlcerationInd
Datatype
text
Beschrijving
Lesion,AnatomicSite
Datatype
text
Beschrijving
CompletedBy
Datatype
text
Beschrijving
FormCompletionDate,Original
Datatype
date
Beschrijving
Ccrr Module For Registration Worksheet (rw)
Beschrijving
Pt.ID
Datatype
text
Beschrijving
InstitutionNo.
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS 2011AA ValueDomain
- C0237753
Beschrijving
PatientName
Datatype
text
Beschrijving
InstitutionName
Datatype
text
Beschrijving
RegistrationDate
Datatype
text
Beschrijving
PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
Datatype
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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