ID

571

Beskrivning

S1011 Surgeon's 90-Day Assessment Form Standard Versus Extended LND (#5223) Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=940453E3-43A8-BBC7-E040-BB89AD431F9F

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=940453E3-43A8-BBC7-E040-BB89AD431F9F

Nyckelord

C80

Harnblasentumoren

2012-08-26 2012-08-26 -
2015-01-09 2015-01-09 - Martin Dugas

Uppladdad den

26 augusti 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Bladder Cancer NCT01224665 Treatment - S1011 Surgeon's 90-Day Assessment Form Standard Versus Extended LND (#5223) - 3153915v1.0

model
Detaljer

Instructions: To be completed by attending surgeon. Please complete 90 days after surgery. Surgeons should be provided with this form prior to the surgical event. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

1 Formulär

StudyEvent: S1011 Surgeon's 90-Day Assessment Form Standard Versus Extended LND (#5223)
1. Instructions: To be completed by attending surgeon. Please complete 90 days after surgery. Surgeons should be provided with this form prior to the surgical event. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header Module

Item Group

Unnamed1

PatientSouthwestOncologyGroupIdentifierNumber

Item

SWOG Patient ID

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

ProtocolSWOGIdentifierNumber

Item

SWOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

PatientInitialsName

Item

Patient Initials (L, F M)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

FormCompletionDate

Item

Date of completion (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

RegisteredInvestigatorName

Item

Physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)

ParticipatingGroupName

Item

Participating Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

SURGICAL COMPLICATIONS

Item Group

Complications

SurgicalProcedureAdverseEventAssessmentInd-2

Item

Was the assessment done

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)

CL.1

Code List

Was the assessment done

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

SurgicalProcedureComplicationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)

SurgicalProcedureComplicationSpecify

Item

Other, specify

text

AdverseEventSymptomBeginDate

Item

Start date (MM DD YYYY should be the date of hospital discharge)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)

AdverseEventSymptomEndDate

Item

Stop date (MM DD YYYY should be 90 days post surgery)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)

SurgicalProcedureComplicationType

Item

Surgical Complications (Record any events that occurred following hospital discharge to 90 days post-op)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)

CL.2

Code List

Surgical Complications (Record any events that occurred following hospital discharge to 90 days post-op)

CL Item

Superficial Wound Infection (Superficial wound infection)

C45234 (NCI Thesaurus)
C0043241 (UMLS 2011AA)
C25239 (NCI Thesaurus)
C0205124 (UMLS 2011AA)

CL Item

Deep Wound Infection (Deep wound infection)

C45234 (NCI Thesaurus)
C0043241 (UMLS 2011AA)
C25240 (NCI Thesaurus)
C0205125 (UMLS 2011AA)

CL Item

Wound Disruption (Wound disruption)

C25486 (NCI Thesaurus)
C0332453 (UMLS 2011AA)
C3671 (NCI Thesaurus)
C0043250 (UMLS 2011AA)

CL Item

Pneumonia (PNEUMONIA)

C3333 (NCI Thesaurus)
C0032285 (UMLS 2011AA)

CL Item

Intubation (Re-intubation)

C37981 (NCI Thesaurus)
C0021925 (UMLS 2011AA)

CL Item

Pulmonary Embolism (Pulmonary Embolism)

C50713 (NCI Thesaurus)
C0034065 (UMLS 2011AA)

CL Item

Deep Vein Thrombosis (Deep venous thrombosis)

C49343 (NCI Thesaurus)
C0149871 (UMLS 2011AA)

CL Item

Failure To Wean From Ventilator Within 48 Hours (Failure to wean from ventilator within 48 hours)

CL Item

Sepsis (Sepsis)

E11560 (CTCAE)

CL Item

Anastomotic Bowel Leak (Anastomotic bowel leak)

CL Item

Renal Insufficiency Dialysis (Renal insufficiency requiring dialysis)

C1565489 (NCI Metathesaurus)
C15221 (NCI Thesaurus)
C0011946 (UMLS 2011AA)

CL Item

Symptomatic Lymph Leakage/lymphocele (Symptomatic lymph leakage/lymphocele)

CL Item

Lymph Leakage/lymphocele Requiring Intervention (Lymph leakage/lymphocele requiring intervention)

CL Item

Acute Renal Failure (Acute renal failure)

C26808 (NCI Thesaurus)
C0022660 (UMLS 2011AA)

CL Item

Urinary Tract Infection (Urinary tract infection)

C50791 (NCI Thesaurus)
C0042029 (UMLS 2011AA)

CL Item

Cerebrovascular Accident Stroke (CVA/stroke)

C3390 (NCI Thesaurus)
C0038454 (UMLS 2011AA)
E12826 (CTCAE)

CL Item

Cardiac Event With Cpr (Cardiac event with CPR)

CL Item

Myocardial Infarction (Myocardial infarction)

E10152 (CTCAE)

CL Item

Ileus (Ileus)

E10812 (CTCAE)

CL Item

Bowel Obstruction (Bowel obstruction)

CL Item

Hemorrhage Postoperative (Bleeding > 4 units postoperative)

C26791 (NCI Thesaurus)
C0019080 (UMLS 2011AA)
C28006 (NCI Thesaurus)
C0032790 (UMLS 2011AA)

CL Item

Death Within 30 Days Of Cystectomy (Death within 30 days of cystectomy)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Other, Specify (Other, Specify)

PatientSurgicalProcedureComplicationGradePresentType

Item

Surgical Complication Grade

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.3

Code List

Surgical Complication Grade

CL Item

Use Of Oral Medications Or Bedside Intervention (Use of oral medications or bedside intervention)

CL Item

Use Of Intravenous Medication, Total Parenteral Nutrition (tpn), Enteral Nutrition, Or Blood Transfusion (Use of intravenous medication, total parenteral nutrition (TPN), enteral nutrition, or blood transfusion)

CL Item

Interventional Radiology, Therapeutic Endoscopy, Intubation, Angiography, Or Operation (Interventional radiology, therapeutic endoscopy, intubation, angiography, or operation)

CL Item

Residual Lasting Disability Requiring Major Rehabilitation Or Organ Resection (Residual lasting disability requiring major rehabilitation or organ resection)

CL Item

Death (Death of patient)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

ADJUVANT TREATMENT RELATED TO THIS BLADDER CANCER

Item Group

Neoadjuvant Treatment Related To This Bladder Cancer

PriorAdjuvantChemotherapyAdministeredInd-2

Item

Prior Adjuvant Chemotherapy

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.4

Code List

Prior Adjuvant Chemotherapy

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AdjuvantChemotherapyAdministeredInd-2

Item

Will the patient receive adjuvant chemotherapy (Please complete if the answer was "No" to adjuvant chemotherapy)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.5

Code List

Will the patient receive adjuvant chemotherapy (Please complete if the answer was "No" to adjuvant chemotherapy)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

ChemotherapyRegimenType

Item

Chemotherapy Regimen (Please complete if the answer was "Yes" to adjuvant chemotherapy select all that apply)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.6

Code List

Chemotherapy Regimen (Please complete if the answer was "Yes" to adjuvant chemotherapy select all that apply)

CL Item

Doxorubicin Vinblastine Methotrexate Cisplatin (MVAC)

C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
C642 (NCI Thesaurus)
C0025677 (UMLS 2011AA)
C930 (NCI Thesaurus)
C0042670 (UMLS 2011AA)

CL Item

Gemcitabine (Gemcitabine)

C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)

CL Item

Cisplatin (Cisplatin)

C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)

CL Item

Carboplatin (Carboplatin)

C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)

CL Item

Paclitaxel (Paclitaxel)

C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)

PriorChemotherapyRegimenText

Item

Specify agent (other)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

AgentCourseCount

Item

Number of Cycles

double

C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)

TreatmentStartDate

Item

Treatment Start Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

AdjuvantTherapyPlanCompleteInd-2

Item

Did the patient complete the planned adjuvant therapy (Please indicate "Yes" if the patient completed the planned adjuvant chemotherapy as of this form submission)

text

C15368 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.7

Code List

Did the patient complete the planned adjuvant therapy (Please indicate "Yes" if the patient completed the planned adjuvant chemotherapy as of this form submission)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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Bladder Cancer NCT01224665 Treatment - S1011 Surgeon's 90-Day Assessment Form Standard Versus Extended LND (#5223) - 3153915v1.0

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