ID

11141

Beskrivning

CALGB: 140503 Surgical Resection Form NCT00499330 Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=218D55B1-930A-6505-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=218D55B1-930A-6505-E044-0003BA3F9857

Nyckelord

Lungentumoren

Clinical Trial

Treatment Form

Uppladdad den

21 juni 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

CALGB: 140503 Surgical Resection Form NCT00499330

model
Detaljer

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

1 Formulär

StudyEvent: CALGB: 140503 Surgical Resection Form
1. INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header

Item Group

Header

Form ID CALGB

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)

Protocol ID CALGB

Item

CALGB Study No

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Trial subject ID CALGB

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Data amended

Item

Are data amended

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Patient demographics

Item Group

Patient demographics

Patient Initials

Item

Patient Initials (Last, First Middle)

text

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

Medical Record Number

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Participating Group

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Operative Data

Item Group

Operative Data

LungSurgicalProcedurePerformedType

Item

Surgical Procedure Type (Post-Operative Data)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)

CL.2

Code List

Surgical Procedure Type (Post-Operative Data)

CL Item

Lobectomy (Lobectomy)

C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)

CL Item

Wedge Resection (Wedge resection)

CL Item

Segmentectomy (Segmentectomy)

CL Item

Incomplete/failed Resection (Incomplete/failed resection)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

LungSurgicalProcedurePerformedSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)

LungIncompleteSurgicalProcedureReasonType

Item

Specify reason

text

C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.3

Code List

Specify reason

CL Item

Positive Lymph Node (Positive Lymph Node)

C27296 (NCI Thesaurus)
C0746319 (UMLS 2011AA)

CL Item

Positive Margins On Permanent Sections (Positive margins on permanent sections)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

LungIncompleteSurgicalProcedureReasonSpecify

Item

Specify

text

C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Surgical Approach

Item

Surgical Approach

text

C25284 (NCI Thesaurus ValueDomain)
C0449446 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

CL.4

Code List

Surgical Approach

CL Item

Thoracotomy (thoracotomy)

CL Item

Thoracoscopy / Video-assisted (vats) (Thoracoscopy / Video-assisted (VATS))

CL Item

Thoracoscopy / Video-assisted (vats), With Conversion To Thoracotomy (Thoracoscopy / Video-assisted (VATS), with conversion to Thoracotomy)

SurgeonVideo-AssistThoracicSurgeryCertificationInd-2

Item

Is the surgeon VATS credentialed (If VATS,)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C18071 (NCI Thesaurus ObjectClass)
C0582175 (UMLS 2011AA ObjectClass)
C43610 (NCI Thesaurus Property)
C0007836 (UMLS 2011AA Property)
C0752151 (NCI Metathesaurus Property)

SurgicalMarginDistanceMeasurement

Item

Surgical Margin Distance (as determined by surgeon)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25698 (NCI Thesaurus ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass)
C25167 (NCI Thesaurus Property)
C0012751 (UMLS 2011AA Property)

SurgicalMarginNotEvaluationText

Item

Is surgical margin not available, mark with an X

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)

SurgicalMarginFrozenSectionPositiveFindingInd-2

Item

If frozen section, does the tumor involve the surgical margin

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C67462 (NCI Thesaurus Property-2)
C0016741 (UMLS 2011AA Property-2)

PermanentSectionSurgicalMarginPositiveFindingInd-2

Item

If permanent section, does the tumor involve the surgical margin

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C67463 (NCI Thesaurus ObjectClass-2)
C1882347 (UMLS 2011AA ObjectClass-2)

PositiveSurgicalMarginTherapyAdministeredType

Item

Specify treatment

text

C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C25698 (NCI Thesaurus ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25563 (NCI Thesaurus ObjectClass-4)
C0205284 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.9

Code List

Specify treatment

CL Item

Anatomic Segmentectomy (Anatomic segmentectomy)

CL Item

No Treatment (No treatment)

CL Item

Off-study Lobectomy (Off-study lobectomy)

CL Item

Re-wedge (Re-wedge)

PositiveSurgicalMarginTherapyAdministeredType

Item

Specify treatment

text

CL.9

Code List

Specify treatment

CL Item

Anatomic Segmentectomy (Anatomic segmentectomy)

CL Item

No Treatment (No treatment)

CL Item

Off-study Lobectomy (Off-study lobectomy)

CL Item

Re-wedge (Re-wedge)

MediastinalLymphNodePhysicalExaminationType

Item

Type of Mediastinal Lymph Node Dissection

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass-2)
C1522718 (UMLS 2011AA ObjectClass-2)

CL.10

Code List

Type of Mediastinal Lymph Node Dissection

CL Item

Complete Mediastinal Lymph Node Dissection (Complete mediastinal lymph node dissection)

CL Item

Systematic Sampling (Systematic sampling)

CL Item

Simple Sampling (Simple sampling)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

Histologic Type

Item

Histology

text

C3262 (NCI Thesaurus ObjectClass)
C0449574 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)

CL.11

Code List

Histology

CL Item

Adenocarcinoma (Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Small Cell Carcinoma (oat Cell) (Small cell carcinoma (oat cell))

CL Item

Benign Mass (Benign mass)

CL Item

Carcinoid (Carcinoid)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Other (Other specify)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)

Histologic Type, other

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)

LungTumorHistologicGrade

Item

Histologic Grade (Differentiation)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)

CL.12

Code List

Histologic Grade (Differentiation)

CL Item

Well Differentiated (Grade I)

C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)

CL Item

Moderately Differentiated (Grade II)

C14162 (NCI Thesaurus)
C0205616 (UMLS 2011AA)

CL Item

Poorly Differentiated (Grade III)

C14167 (NCI Thesaurus)
C0205617 (UMLS 2011AA)

CL Item

Undifferentiated (Grade IV)

C14176 (NCI Thesaurus)
C0205618 (UMLS 2011AA)

TumorMaximumDiameterMeasurement

Item

Maximum Diameter (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25564 (NCI Thesaurus Property-2)
C0806909 (UMLS 2011AA Property-2)

Pathologic T-N-M Staging

Item Group

Pathologic T-N-M Staging

T Stage pathologic

Item

Pathologic T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0475455 (UMLS CUI-1)
C16899 (NCI Thesaurus ValueDomain)
C1521733 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)

CL.13

Code List

Pathologic T Stage

CL Item

Primary Tumor Cannot Be Assessed, Or Tumor Proven By The Presence Of Malignant Cells In Sputum Or Bronchial Washings But Not Visualized By Imaging Or Bronchoscopy (TX)

CL Item

No Evidence Of Primary Tumor (T0)

CL Item

Carcinoma In Situ (Tis)

C2917 (NCI Thesaurus)
C0007099 (UMLS 2011AA)
C2917 (NCI Thesaurus-3)
C0007099 (UMLS 2011AA-4)

CL Item

Tumor 3 Cm Or Less In Greatest Dimension, Surrounded By Lung Or Visceral Pleura, Invasion More Proximal Than The Lobar Bronchus, (i.e., Not In The Main Bronchus) (T1)

CL Item

Tumor With Any Of The Following Features Of Size Or Extent: More Than 3cm In Greatest Dimension; Invades The Visceral Pleura; Associated With Atelectasis Or Obstructive Pneumonitis That Extends To The Hilar Region But Does Not Involve The Entire Lung (T2)

CL Item

Tumor Of Any Size That Directly Invades Any Of The Following: Chest Wall (including Superior Sulcus Tumors), Diaphragm, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus Less Than 2 Cm Distal To The Carina, But Without Involvement O* (T3)

CL Item

Tumor Of Any Size That Invades Any Of The Following: Mediastinum, Heart, Great Vessels, Trachea, Esophagus, Vertebral Body, Carina; Or Separate Tumor Nodules In The Same Lobe; Or Tumor With A Malignant Pleural Effusion (T4)

N Stage pathologic

Item

Pathologic N Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0456532 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C1521733 (UMLS CUI-2)
C25610 (NCI Thesaurus Property)
C25580 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)

CL.14

Code List

Pathologic N Stage

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (N1)

CL Item

Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (N2)

CL Item

Metastasis To Contralateral Mediastinal, Contralateral Hilar, Ipsilateral Or Contralateral Scalene, Or Supraclavicular Lymph Node(s) (N3)

CL Item

Regional Lymph Nodes Cannot Be Assessed (NX)

M Stage clinical

Item

Clinical M Stage ([M] Mark one with an X.)

text

C3262 (NCI Thesaurus ObjectClass)
C0456533 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25727 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)

CL.15

Code List

Clinical M Stage ([M] Mark one with an X.)

CL Item

No Distant Metastasis (M0)

CL Item

Distant Metastasis Present (M1)

CL Item

Distant Metastasis Cannot Be Assessed (MX)

Footer Module

Item Group

Surgical Complications And Morbidities

Person Completing Form

Item

Completed by

text

C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Form Completion Date

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Tillbaka till toppen

ID

Beskrivning

Länk

Nyckelord

Versioner (3)

Uppladdad den

DOI

Licens

Modellkommentarer :

Itemgroup-kommentar för :

Item-kommentar för :

CALGB: 140503 Surgical Resection Form NCT00499330

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning