ID

8562

Beschreibung

Kaposi's Sarcoma Evaluation - RKS02B Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=CCE28BEA-7B40-47F1-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=CCE28BEA-7B40-47F1-E034-0003BA12F5E7

Stichworte

Sarkom, Kaposi-

Klinische Studie [Dokumenttyp]

19.09.12 19.09.12 -
09.01.15 09.01.15 - Martin Dugas

Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Sarcoma, Kaposi xxx On-Study - Kaposi's Sarcoma Evaluation - RKS02B - 2266721v3.0

Modell
Details

No Instruction available.

StudyEvent: Kaposi's Sarcoma Evaluation - RKS02B
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Item Group

Ccrr Module For Kaposi's Sarcoma Evaluation - Rks02b

Patient Initials

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Protocol ID Coordinating Group

Item

Study#

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

NCIInstitutionIdentifierCode

Item

Site#

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus ObjectClass-2)
C1513882 (UMLS 2011AA ObjectClass-2)

Patient Study ID

Item

ID#

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Cycle Number Chemotherapeutics

Item

Cycle #

text

C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)

Assessment Date

Item

Date of Procedure

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Assessment Date

Item

Date of Procedure

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

AssessmentReportingPeriodType

Item

Which Karposi's Sarcoma evaluation does this represent?

text

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)

Code List

Which Karposi's Sarcoma evaluation does this represent?

CL Item

Prior To Study Entry (Entry/Baseline)

CL Item

On Study (On Treatment)

CL Item

Follow-up (Post Therapy Evaluation)

C16033 (NCI Thesaurus)
C1522577 (UMLS 2011AA)

CL Item

Off Treatment (Off treatment)

C25601 (NCI Thesaurus)
C1518544 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Other, Specify (Other, specify)

CL Item

End Of Therapy (End of therapy)

LesionCount

Item

Lesion Count

boolean

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)

Lesion Site, Primary

Item

Specify

text

C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)

TumorResponseType

Item

Number of lesions

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)

Code List

Number of lesions

CL Item

Complete Response (Complete Resolution)

CL Item

Incomplete Response Or Stable Disesase (>=50% decrease in the sum of the product of the diameters of all marker lesions since baseline)

CL Item

Progressive Disease (>=25% increse in the sum of the products of the diameters of all marker lesions since baseline, or since best response)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

None of the above (None of the above)

CL Item

Death Prior To Completion Of Protocol Criteria (Early death)

CL Item

Insufficient Evaluation (Insufficient evaluation to determine response status)

CL Item

Stable Disease (SD)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

CL Item

Incomplete Response Or Stable Disesase (Incomplete response/SD)

LesionSiteICD-OCode

Item

Oral Site

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)

Code List

Oral Site

CL Item

Gingiva/Gums (Gingiva/Gums)

CL Item

Hard Palate (Hard Palate)

CL Item

Soft Palate (Soft Palate)

CL Item

Buccal Mucosa (Buccal Mucosa)

CL Item

Tongue (Tongue)

CL Item

Floor of Mouth (Floor of Mouth)

CL Item

Tonsils (Tonsils)

CL Item

Uvula (Uvula)

CL Item

Posterior Pharnyx (Posterior Pharnyx)

LesionSiteICD-OCode

Item

Oral Site

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)

Code List

Oral Site

CL Item

Gingiva/Gums (Gingiva/Gums)

CL Item

Hard Palate (Hard Palate)

CL Item

Soft Palate (Soft Palate)

CL Item

Buccal Mucosa (Buccal Mucosa)

CL Item

Tongue (Tongue)

CL Item

Floor of Mouth (Floor of Mouth)

CL Item

Tonsils (Tonsils)

CL Item

Uvula (Uvula)

CL Item

Posterior Pharnyx (Posterior Pharnyx)

LesionSiteICD-OCode

Item

Oral Site

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)

Code List

Oral Site

CL Item

Gingiva/Gums (Gingiva/Gums)

CL Item

Hard Palate (Hard Palate)

CL Item

Soft Palate (Soft Palate)

CL Item

Buccal Mucosa (Buccal Mucosa)

CL Item

Tongue (Tongue)

CL Item

Floor of Mouth (Floor of Mouth)

CL Item

Tonsils (Tonsils)

CL Item

Uvula (Uvula)

CL Item

Posterior Pharnyx (Posterior Pharnyx)

Documented clinical assessment for this cancer

Item

Has a visceral disease evaluation been done since the last KS evaluation

boolean

C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)

Evaluation method

Item

Proced

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

Code List

Proced

CL Item

Upper endoscopy (Upper endoscopy)

CL Item

Colonoscopy (Colonoscopy)

C16450 (NCI Thesaurus)
C0009378 (UMLS 2011AA)

CL Item

Sigmoldoscopy (Sigmoldoscopy)

CL Item

Chest X-ray (Chest X-ray)

CL Item

Bronchoscopy (Bronchoscopy)

C16366 (NCI Thesaurus)
C0006290 (UMLS 2011AA)

CL Item

Ct Scan (Computerized tomography)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Evaluation method, specify

Item

Specify Procedure

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

OverallTumorResponseType

Item

Best overall response attained since Entry/Baseline:

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C1561607 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)

Code List

Best overall response attained since Entry/Baseline:

CL Item

Complete Response (Complete.)

CL Item

Complete Response (Clinical complete response)

CL Item

Partial Response (Partial Response)

C18212 (NCI Thesaurus)

CL Item

Stable Disease (Stable)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

CL Item

Partial Response (Progression)

C18212 (NCI Thesaurus)

CL Item

Insufficient Evaluation (Unevaluable)

CL Item

Unknown (Unknown)

CL Item

Death Prior To Completion Of Protocol Criteria (Early death)

CL Item

Progressive Disease (PD)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Incomplete Response Or Stable Disesase (Incomplete response/SD)

DiseaseProgressionDate

Item

Date of relapse, if applicable

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

Complete Response First Observed Date

Item

Complete response date

date

C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

CompleteResponseConfirmedDate

Item

Clinical complete response date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C0205197 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)

Partial Response First Observed Date

Item

Partial Response date

date

C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Progressive Disease Observed Date

Item

Progression with no prior response date

date

C25164 (NCI Thesaurus ValueDomain)
C1335499 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus ObjectClass)
C25599 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)

TotalNumberRaisedLesions

Item

Total Number Raised Lesions

text

TotalNumberFlatLesions

Item

Total Number Flat Lesions

text

Numberoflesions

Item

Number of lesions

text

Code List

Number of lesions

CL Item

Complete Resolution (Complete Resolution)

CL Item

>=50% decrease in the number of lesions since baseline (>=50% decrease in the number of lesions since baseline)

CL Item

>=25% increase in the number of lesions since baseline or since best response (>=25% increase in the number of lesions since baseline or since best response)

CL Item

None of the above (None of the above)

Characterofcutaneouslesions

Item

Character of cutaneous lesions

text

Code List

Character of cutaneous lesions

CL Item

Since baseline, >=50% of raised have become flat (Since baseline, >=50% of raised have become flat)

CL Item

>=25% increase in the number of raised lesions since baseline or since best response (>=25% increase in the number of raised lesions since baseline or since best response)

CL Item

None of the above (None of the above)

PerpendicularDiameters

Item

Perpendicular Diameters

text

ProductofDiameters

Item

Product of Diameters

text

Item

Unnamed

text

Code List

Unnamed

CL Item

Raised Lesion (Raised Lesion)

CL Item

Flat Lesion (Flat Lesion)

SumofProducts

Item

Sum of Products

text

Arethereanyoralcavitylesionspresentatthisevaluation

Item

Are there any oral cavity lesions present at this evaluation

boolean

Kaposi'sSarcomaPresent

Item

Kaposi's Sarcoma Present

boolean

Item

Oral lesions

text

Code List

Oral lesions

CL Item

A resolution of all oral lesions since baseline (A resolution of all oral lesions since baseline)

CL Item

An improvement of oral lesions since baseline (An improvement of oral lesions since baseline)

CL Item

A worsening of oral lesions since baseline or best response (A worsening of oral lesions since baseline or best response)

CL Item

New oral lesions (New oral lesions)

CL Item

None of the above (None of the above)

Isthereanytumor-associatededemaatthisevaluation

Item

Is there any tumor-associated edema at this evaluation

boolean

Item

Edema Site

text

Code List

Edema Site

CL Item

Periorbital (Periorbital)

CL Item

Genital (Genital)

CL Item

Right Arm (Right Arm)

CL Item

Left Arm (Left Arm)

CL Item

Right Leg (Right Leg)

CL Item

Left Leg (Left Leg)

CL Item

Right Hand (Right Hand)

CL Item

Left Hand (Left Hand)

CL Item

Right Foot (Right Foot)

CL Item

Left Foot (Left Foot)

CL Item

Other (Other)

Otherspecify

Item

Other specify

text

EdemaPresent

Item

Edema Present

boolean

Tumorassociatededema

Item

Tumor associated edema

text

Code List

Tumor associated edema

CL Item

A resolution of all tumor-associated edema since baseline (A resolution of all tumor-associated edema since baseline)

CL Item

An improvement of tumor-associated edema since baseline (An improvement of tumor-associated edema since baseline)

CL Item

A worsening of tumor-associated edema since baseline or best response (A worsening of tumor-associated edema since baseline or best response)

CL Item

New tumor-associated edema (New tumor-associated edema)

CL Item

No change (No change)

SiteCode

Item

Site Code

text

SpecifySite

Item

Specify Site

text

Item

KS Invol

text

Code List

KS Invol

CL Item

Present (Present)

CL Item

Absent (Absent)

Item

Visc Eval

text

Code List

Visc Eval

CL Item

A complete resolution of visceral disease since baseline (A complete resolution of visceral disease since baseline)

CL Item

A decrease in visceral disease since baseline (A decrease in visceral disease since baseline)

CL Item

A worsening of visceral disease since baseline, or since the best response (A worsening of visceral disease since baseline, or since the best response)

CL Item

Evidence of a new site of visceral disease (Evidence of a new site of visceral disease)

CL Item

No change (No change)

CL Item

Not applicable, Entry/Baseline evaluation (Not applicable, Entry/Baseline evaluation)

Whatisthepresentstatusofthebestresponse?

Item

What is the present status of the best response?

text

Code List

What is the present status of the best response?

CL Item

Response continuing or first time at this response (Response continuing or first time at this response)

CL Item

Relapse occurred after a response was achieved (Relapse occurred after a response was achieved)

CL Item

No relapse ovserved, but patient died (No relapse ovserved, but patient died)

CL Item

Not applicable (Not applicable)

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