Malignant Mesothelioma NCT01064648 Registration - Southwest Oncology Group S0905 Registration Worksheet - Registration Step 1 - 2987153v1.0 - Portaal voor medische datamodellen (MDM-portaal)

ID

9001

Beschrijving

Southwest Oncology Group S0905 Registration Worksheet - Registration Step 1 Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7D36D635-C082-5CC0-E040-BB89AD4304B4

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7D36D635-C082-5CC0-E040-BB89AD4304B4

Trefwoorden

D016430

Registration

Mesotheliom

19-09-12 19-09-12 -
09-01-15 09-01-15 - Martin Dugas

Geüploaded op

9 januari 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

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INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

1 Formulieren

StudyEvent: Southwest Oncology Group S0905 Registration Worksheet - Registration Step 1
1. INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

Unnamed2

Beschrijving

Unnamed2

SWOG Patient ID Status

Beschrijving

PatientSouthwestOncologyGroupIdentifierStatus

Datatype

text

Alias

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus Property-2: C25699

UMLS 2011AA Property-2: C1519429

NCI Thesaurus ValueDomain: C25688

UMLS 2011AA ValueDomain: C0449438

New Patient (New patient)

Previous Patient (Previous patient)

SWOG Patient ID

Beschrijving

Trial subject ID SWOG

Datatype

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS CUI-1: C2348585

NCI Thesaurus ObjectClass: C16960

UMLS CUI-2: C1519429

NCI Thesaurus Property: C25364

NCI Thesaurus Property-2: C25699

Unnamed5

Beschrijving

Unnamed5

Patient First Name

Beschrijving

First Name

Datatype

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS CUI-1: C1443235

NCI Thesaurus ObjectClass: C16960

NCI Thesaurus Property: C25364

NCI Thesaurus Property-2: C25509

Patient Middle Name

Beschrijving

PatientMiddleName

Datatype

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS 2011AA ValueDomain: C1547383

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus Property-2: C25569

UMLS 2011AA Property-2: C0444598

Patient Last Name

Beschrijving

Last Name

Datatype

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS CUI-1: C1301584

NCI Thesaurus ObjectClass: C16960

NCI Thesaurus Property: C25364

NCI Thesaurus Property-2: C25551

Unnamed4

Beschrijving

Unnamed4

Registrar's SWOG Roster ID Number

Beschrijving

RegistrarSouthwestOncologyGroupIdentifierNumber

Datatype

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus Property-2: C25699

UMLS 2011AA Property-2: C1519429

NCI Thesaurus ObjectClass: C25357

UMLS 2011AA ObjectClass: C0557514

SWOG Investigator Number

Beschrijving

SouthwestOncologyGroupInvestigatorIdentifierNumber

Datatype

float

Alias

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus ObjectClass: C25699

UMLS 2011AA ObjectClass: C1519429

NCI Thesaurus ObjectClass-2: C17089

UMLS 2011AA ObjectClass-2: C0035173

SWOG Treating Institution Number

Beschrijving

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Datatype

float

Alias

NCI Thesaurus ObjectClass: C25699

UMLS 2011AA ObjectClass: C1519429

NCI Thesaurus ObjectClass-2: C25705

UMLS 2011AA ObjectClass-2: C1522326

NCI Thesaurus ObjectClass-3: C41206

UMLS 2011AA ObjectClass-3: C1272753

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

Patient Information

Beschrijving

Patient Information

Date Informed Consent Signed

Beschrijving

InformedConsentFormSignedDate

Datatype

date

Alias

NCI Thesaurus ValueDomain: C25164

UMLS 2011AA ValueDomain: C0011008

NCI Thesaurus ValueDomain-2: C25367

NCI Thesaurus ObjectClass: C16468

UMLS 2011AA ObjectClass: C0009797

NCI Thesaurus Property: C25679

Date HIPAA Authorization signed (Not required if Country of Residence is not USA)

Beschrijving

HIPAA Approval Date

Datatype

date

Alias

NCI Thesaurus ValueDomain: C25164

UMLS CUI-1: C0600593

NCI Thesaurus ObjectClass: C25320

UMLS CUI-2: C2346844

NCI Thesaurus Property: C25425

Projected Start Date of Treatment

Beschrijving

Treatment Begin Date

Datatype

date

Alias

NCI Thesaurus ObjectClass: C15368

NCI Thesaurus ObjectClass-2: C25631

NCI Thesaurus Property: C25431

UMLS CUI-1: C3173309

NCI Thesaurus Property-2: C25275

NCI Thesaurus ValueDomain: C25164

NCI Thesaurus ValueDomain-2: C25431

Unnamed5

Beschrijving

Unnamed5

Performance status

Beschrijving

PerformanceStatusAssessmentPerformanceStatusStratificationCode

Datatype

float

Alias

NCI Thesaurus ValueDomain: C25162

UMLS 2011AA ValueDomain: C0805701

NCI Thesaurus Property: C25367

NCI Thesaurus ObjectClass: C20641

UMLS 2011AA ObjectClass: C1518965

NCI Thesaurus ValueDomain-2: C25689

UMLS 2011AA ValueDomain-2: C1514983

Histologic subtype

Beschrijving

LungTumorHistologicClassificationStratificationCode

Datatype

float

Alias

NCI Thesaurus ObjectClass: C3262

UMLS 2011AA ObjectClass: C0027651

NCI Thesaurus ObjectClass-2: C12468

UMLS 2011AA ObjectClass-2: C0024109

NCI Thesaurus Property: C25526

UMLS 2011AA Property: C0205462

NCI Thesaurus Property-2: C25365

UMLS 2011AA Property-2: C0678257

NCI Thesaurus ValueDomain: C25162

UMLS 2011AA ValueDomain: C0805701

NCI Thesaurus ValueDomain-2: C25689

UMLS 2011AA ValueDomain-2: C1514983

Unnamed4

Beschrijving

Unnamed4

My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.

Beschrijving

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Datatype

boolean

Alias

NCI Thesaurus ObjectClass: C25190

UMLS 2011AA ObjectClass: C0027361

NCI Thesaurus Property: C15319

NCI Thesaurus Property-2: C9305

UMLS 2011AA Property: C0006826

NCI Thesaurus Property-3: C19157

UMLS 2011AA Property-2: C0370003

NCI Thesaurus Property-4: C25460

UMLS 2011AA Property-3: C1511481

NCI Thesaurus ValueDomain: C38147

UMLS 2011AA ValueDomain: C1512698

Yes

My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).

Beschrijving

PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

Datatype

boolean

Alias

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus Property: C17649

UMLS 2011AA Property: C0205394

NCI Thesaurus Property-2: C2991

UMLS 2011AA Property-2: C0012634

NCI Thesaurus Property-3: C15206

UMLS 2011AA Property-3: C0008972

NCI Thesaurus Property-4: C25460

UMLS 2011AA Property-4: C1511481

NCI Thesaurus ValueDomain: C38147

UMLS 2011AA ValueDomain: C1512698

Yes

Someone may contact me in the future to ask me to allow other uses of my specimens.

Beschrijving

Permission to contact Patient

Datatype

boolean

Alias

NCI Thesaurus ObjectClass: C16960

UMLS CUI-1: C1522577

NCI Thesaurus Property: C67527

UMLS CUI-2: C0521104

NCI Thesaurus Property-2: C25460

NCI Thesaurus Property-3: C16452

NCI Thesaurus ValueDomain: C38148

Yes

I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study

Beschrijving

SouthwestOncologyGroupPatientResearchConsentInd-2

Datatype

boolean

Alias

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus ObjectClass-2: C25699

UMLS 2011AA ObjectClass-2: C1519429

NCI Thesaurus Property: C15319

NCI Thesaurus Property-2: C25460

UMLS 2011AA Property: C1511481

NCI Thesaurus ValueDomain: C38147

UMLS 2011AA ValueDomain: C1512698

Yes

Patient Eligibility

Beschrijving

Patient Eligibility

Has the Southwest Oncology Group Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0

Beschrijving

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

Datatype

boolean

Alias

NCI Thesaurus ObjectClass: C16960

UMLS 2011AA ObjectClass: C0030705

NCI Thesaurus ObjectClass-2: C25699

UMLS 2011AA ObjectClass-2: C1519429

NCI Thesaurus Property: C25646

UMLS 2011AA Property: C1514821

NCI Thesaurus Property-2: C25171

UMLS 2011AA Property-2: C0013893

NCI Thesaurus ValueDomain: C38147

UMLS 2011AA ValueDomain: C1512698

Yes

Auxiliary Questions

Beschrijving

Auxiliary Questions

Courier Name (select one)

Beschrijving

ShippingCompanyIdentifierName

Datatype

text

Alias

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus ObjectClass: C54131

UMLS 2011AA ObjectClass: C0683757

NCI Thesaurus ObjectClass-2: C40353

UMLS 2011AA ObjectClass-2: C1524049

NCI Thesaurus ValueDomain: C42614

UMLS 2011AA ValueDomain: C0027365

U.s. Priority Mail (U.S. Priority Mail)

Federal Express (Federal Express)

Ups (UPS)

Courier Account # (enter NA if not applicable)

Beschrijving

InstitutionShippingCompanyIdentifierNumber

Datatype

text

Alias

NCI Thesaurus ObjectClass: C41206

UMLS 2011AA ObjectClass: C1272753

NCI Thesaurus Property: C25364

UMLS 2011AA Property: C0600091

NCI Thesaurus Property-2: C54131

UMLS 2011AA Property-2: C0683757

NCI Thesaurus Property-3: C40353

UMLS 2011AA Property-3: C1524049

NCI Thesaurus ValueDomain: C25337

UMLS 2011AA ValueDomain: C0237753

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INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

1 Formulieren

StudyEvent: Southwest Oncology Group S0905 Registration Worksheet - Registration Step 1
1. INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

SWOG Patient ID

Item Group

Unnamed2

PatientSouthwestOncologyGroupIdentifierStatus

Item

SWOG Patient ID Status

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.1

Code List

SWOG Patient ID Status

CL Item

New Patient (New patient)

CL Item

Previous Patient (Previous patient)

Trial subject ID SWOG

Item

SWOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)

Demographic Information

Item Group

Unnamed5

First Name

Item

Patient First Name

text

C25191 (NCI Thesaurus ValueDomain)
C1443235 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)

PatientMiddleName

Item

Patient Middle Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)

Last Name

Item

Patient Last Name

text

C25191 (NCI Thesaurus ValueDomain)
C1301584 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)

For SWOG Institutions

Item Group

Unnamed4

RegistrarSouthwestOncologyGroupIdentifierNumber

Item

Registrar's SWOG Roster ID Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25357 (NCI Thesaurus ObjectClass)
C0557514 (UMLS 2011AA ObjectClass)

SouthwestOncologyGroupInvestigatorIdentifierNumber

Item

SWOG Investigator Number

float

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Item

SWOG Treating Institution Number

float

C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

Patient Information

Item Group

Patient Information

InformedConsentFormSignedDate

Item

Date Informed Consent Signed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

HIPAA Approval Date

Item

Date HIPAA Authorization signed (Not required if Country of Residence is not USA)

date

C25164 (NCI Thesaurus ValueDomain)
C0600593 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2346844 (UMLS CUI-2)
C25425 (NCI Thesaurus Property)

Treatment Begin Date

Item

Projected Start Date of Treatment

date

C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Stratification Question

Item Group

Unnamed5

PerformanceStatusAssessmentPerformanceStatusStratificationCode

Item

Performance status

float

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus ValueDomain-2)
C1514983 (UMLS 2011AA ValueDomain-2)

LungTumorHistologicClassificationStratificationCode

Item

Histologic subtype

float

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)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25689 (NCI Thesaurus ValueDomain-2)
C1514983 (UMLS 2011AA ValueDomain-2)

Indicate how the patient answered the following questions on the consent form

Item Group

Unnamed4

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Item

My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

Item

My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Permission to contact Patient

Item

Someone may contact me in the future to ask me to allow other uses of my specimens.

boolean

C16960 (NCI Thesaurus ObjectClass)
C1522577 (UMLS CUI-1)
C67527 (NCI Thesaurus Property)
C0521104 (UMLS CUI-2)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)

SouthwestOncologyGroupPatientResearchConsentInd-2

Item

I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Patient Eligibility

Item Group

Patient Eligibility

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

Item

Has the Southwest Oncology Group Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Auxiliary Questions

Item Group

Auxiliary Questions

ShippingCompanyIdentifierName

Item

Courier Name (select one)

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C54131 (NCI Thesaurus ObjectClass)
C0683757 (UMLS 2011AA ObjectClass)
C40353 (NCI Thesaurus ObjectClass-2)
C1524049 (UMLS 2011AA ObjectClass-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

CL.9

Code List

Courier Name (select one)

CL Item

U.s. Priority Mail (U.S. Priority Mail)

CL Item

Federal Express (Federal Express)

CL Item

Ups (UPS)

InstitutionShippingCompanyIdentifierNumber

Item

Courier Account # (enter NA if not applicable)

text

C41206 (NCI Thesaurus ObjectClass)
C1272753 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C54131 (NCI Thesaurus Property-2)
C0683757 (UMLS 2011AA Property-2)
C40353 (NCI Thesaurus Property-3)
C1524049 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

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Malignant Mesothelioma NCT01064648 Registration - Southwest Oncology Group S0905 Registration Worksheet - Registration Step 1 - 2987153v1.0

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