ID
2613
Description
Registration Worksheet (RW) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B123165F-AFDA-4C3D-E034-0003BA12F5E7
Link
Keywords
Versions (1)
- 9/19/12 9/19/12 -
Uploaded on
September 19, 2012
DOI
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License
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.
Description
Inclusion Criteria:
Description
Patientmustbe>18yearsofageatstudyregistration.
Data type
text
Description
PatientmusthaveprimaryinvasivecutaneousmelanomaofBreslowthickness2mmorgreater,asdeterminedbydiagnosticbiopsy(excisional,punch,orshave),within90dayspriortoregistration.
Data type
text
Description
Historyandphysicalexamination.Patientwithsigns,symptoms,orphysicalexamfindingssuspiciousformetastaticdiseasemustundergofurtherevaluationinordertomaintaineligibility(seeRecommendationsforEvaluationofPotentialMetastaticDiseas
Data type
text
Description
P/AandlateralchestX-ray(CXR).PatientwithabnormalCXRfindingssuspiciousformetastaticdiseasemusthaveanegativeorequivocalchestCTorFDG-PETinordertomaintaineligibility.
Data type
text
Description
Serumlactatedehydrogenase(LDH)level.PatientwithanelevatedserumLDH,definedasaserumlevelgreaterthantheupperlimitofinstitutionalnormal,musthaveanegativeorequivocalCTscan,MRI,ultrasound,orFDG-PEToftheabdomeninordertom
Data type
text
Description
Patientorthepatient?slegallyacceptablerepresentativemustprovideasignedanddatedwritteninformedconsentpriortoregistrationandanystudy-relatedprocedures.
Data type
text
Description
AsurvivorofpriorcanceriseligibleprovidedthatALLofthefollowingcriteriaaremetanddocumented:
Data type
text
Description
Exclusion Criteria:
Description
Patienthasprimarymelanomaofmucosalorocularorigin,orlocatedonafingerdistaltothemetacarpophalangealjoint,onatoedistaltothemetatarsophalangealjoint,onthetipofthenose,ontheeyelidsorontheear.
Data type
text
Description
Patienthasahistoryofanon-indexprimarymelanomaofBreslowthickness1mmorgreater,oranypriormelanomawithahistoryoflymphatic,in-transit,ordistantmetastases.
Data type
text
Description
Patienthasclinicalevidenceofregionallymphnodemetastasesasevidencedbysuspiciouspalpableregionallymphadenopathyorbiopsy.
Data type
text
Description
Patienthascutaneousin-transitmetastases(morethan2cmfromtheprimarytumor)orgrossclinicalevidenceofsatellitosis(lessthan2cmfromprimarytumor).
Data type
text
Description
Patientpreviouslyhashadawideexcisionofamelanomaatthesiteoftheindexlesion.
Data type
text
Description
Patienthashadpriorlymphaticsurgery(i.e.,lymphnodedissectionsoropenlymphnodebiopsies,includingsentinellymphnodebiopsies),inthearea(s)ofpotentiallymphaticdrainageoftheindexmelanoma.
Data type
text
Description
Patienthasclinicalorradiographicevidenceofprobablemetastaticdisease.
Data type
text
Description
ACOSOGPatientEligibilityInd-2
Data type
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
Description
Randomization
Description
Indicatearmassigned:
Data type
text
Description
BiopsyDate
Data type
date
Description
AssessmentDate
Data type
date
Description
ChestX-RayAssessmentDate
Data type
date
Description
Lab,Hematology,SampleCollectionDate
Data type
date
Description
IsLDHgreaterthanupperlimitofinstitutionalnorm:
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C38148
- UMLS 2011AA ValueDomain
- C1512699
Description
Stratification
Description
BreslowDepth
Data type
double
Description
UlcerationInd
Data type
text
Description
Lesion,AnatomicSite
Data type
text
Description
CompletedBy
Data type
text
Description
FormCompletionDate,Original
Data type
date
Description
Ccrr Module For Registration Worksheet (rw)
Description
Pt.ID
Data type
text
Description
InstitutionNo.
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS 2011AA ValueDomain
- C0237753
Description
PatientName
Data type
text
Description
InstitutionName
Data type
text
Description
RegistrationDate
Data type
text
Description
PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
Data type
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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