ID

23122

Description

GOG Recurrent Gynecologic Cancer - On Study Form Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix On Study Form - 2058732v3.0

Keywords

  1. 8/27/12 8/27/12 -
  2. 6/24/17 6/24/17 - Martin Dugas
Uploaded on

June 24, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Cervical Cancer Cisplatin NCT00064077 GOG

FORM OS-R

  1. StudyEvent: GOG Recurrent Gynecologic Cancer - On Study Form
    1. FORM OS-R
Header Module
Description

Header Module

Alias
UMLS CUI-1
C1320722
Date form originally completed
Description

Form Completion Date

Data type

date

Alias
UMLS CUI [1]
C1549507
Date form amended
Description

Form Completion Date, amended

Data type

date

Measurement units
  • m d y
Alias
UMLS CUI [1,1]
C0680532
UMLS CUI [1,2]
C0011008
m d y
Person amending form, last name
Description

Responsible Person Reporting Change LastName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25364
UMLS CUI [1,1]
C0680532
UMLS CUI [1,2]
C1547383
Patient Name, Last
Description

Patient Name, Last

Data type

text

Alias
UMLS CUI [1]
C1301584
Patient Name, First
Description

Patient Name, First

Data type

text

Alias
UMLS CUI [1]
C1443235
Patient Study ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Person Completing Form, Last Name
Description

Person Completing Form, LastName

Data type

text

Alias
UMLS CUI [1,1]
C1550483
UMLS CUI [1,2]
C1301584
Participating Group Code
Description

Participating Group Code

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS CUI [1]
C2986314
Participating Group Protocol Number
Description

Participating Group Protocol Number

Data type

text

Alias
UMLS CUI [1,1]
C3274381
UMLS CUI [1,2]
C2347449
Participating Patient Study ID
Description

Patient Participating Identifier Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2347449
COMMENTS
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Disease Description - Prior History
Description

Disease Description - Prior History

Alias
UMLS CUI-1
C0455458
Date of definitive histologic diagnosis of primary tumor
Description

Primary Tumor Diagnosis Date

Data type

date

Measurement units
  • m d y
Alias
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C15220
UMLS CUI [1,1]
C4296634
m d y
Stage (at diagnosis FIGO)
Description

Stage Grouping

Data type

text

Alias
UMLS CUI [1]
C1300072
Primary surgery date
Description

Primary Surgery Date

Data type

date

Measurement units
  • m d y
Alias
UMLS CUI [1]
C1628561
m d y
Primary surgery type (check all that apply)
Description

Primary Surgery Type

Data type

integer

Other (Primary Surgery Type), specify
Description

Primary Surgery

Data type

text

Alias
UMLS CUI [1]
C0543467
Disease Description - Current History
Description

Disease Description - Current History

Alias
UMLS CUI-1
C0262926
Current status of disease
Description

Disease Status

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Date of first recurrence or progression
Description

Progression Date, First

Data type

date

Measurement units
  • m d y
Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0011008
m d y
What was the method used to determine progression? (recurrence or check all that apply)
Description

Progression Assessment Method

Data type

integer

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0430022
Site(s) of disease (at study entry check all that apply)
Description

Disease Site

Data type

integer

Alias
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass-2
C12971
UMLS CUI [1]
C1290853
Other (Sites of Disease), specify
Description

Disease Site, other

Data type

text

Alias
UMLS CUI [1]
C1290853
Prior Treatment For Gynecologic Cancer
Description

Prior Treatment For Gynecologic Cancer

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0699889
Prior systemic chemotherapy?
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
Date prior chemotherapy started
Description

Prior Chemotherapy Begin Date

Data type

date

Measurement units
  • m d y
Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0808070
m d y
Date prior chemotherapy ended
Description

Prior Chemotherapy End Date

Data type

date

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0806020
Chemotherapy regimen
Description

Prior Chemotherapy Regimen

Data type

integer

Alias
UMLS CUI [1]
C1514457
Second line chemotherapy, specify agent(s)
Description

Second line Chemotherapy

Data type

text

Alias
UMLS CUI [1]
C2045828
Other, specify agent(s)
Description

Prior Chemotherapy, other

Data type

text

Alias
UMLS CUI [1]
C1514457
No. of courses
Description

Chemotherapy, number of cycles

Data type

integer

Alias
UMLS CUI [1]
C2045831
Prior hormonal therapy?
Description

Prior Hormonal Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514460
Yes (Prior Hormonal), specify
Description

Prior Hormonal Therapy Type

Data type

text

Alias
UMLS CUI [1]
C1514460
Non-protocol biologic response modifier (BRM)?
Description

Biological Response Modifier Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0005527
Yes, (Non-protocol BRM) specify
Description

BRM, non-protocol

Data type

text

Alias
NCI Thesaurus ObjectClass
C25590
NCI Thesaurus ObjectClass-2
C2167
NCI Thesaurus Property
C25382
UMLS CUI [1,1]
C0005527
UMLS CUI [1,2]
C1518384
Prior radiation therapy?
Description

PriorRTInd

Data type

text

Yes, (Prior RT) specify
Description

Non-Protocol radiotherapy

Data type

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1518384
Is the site of recurrence within the field previously treated by radiation therapy?
Description

Recurrence Site treated by radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C1522449

Similar models

FORM OS-R

  1. StudyEvent: GOG Recurrent Gynecologic Cancer - On Study Form
    1. FORM OS-R
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
C1320722 (UMLS CUI-1)
Form Completion Date
Item
Date form originally completed
date
C1549507 (UMLS CUI [1])
Form Completion Date, amended
Item
Date form amended
date
C0680532 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Responsible Person Reporting Change LastName
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C0680532 (UMLS CUI [1,1])
C1547383 (UMLS CUI [1,2])
Patient Name, Last
Item
Patient Name, Last
text
C1301584 (UMLS CUI [1])
Patient Name, First
Item
Patient Name, First
text
C1443235 (UMLS CUI [1])
Patient Study ID
Item
Patient Study ID
text
C2348585 (UMLS CUI [1])
Person Completing Form, LastName
Item
Person Completing Form, Last Name
text
C1550483 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
Participating Group Code
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C2986314 (UMLS CUI [1])
Participating Group Protocol Number
Item
Participating Group Protocol Number
text
C3274381 (UMLS CUI [1,1])
C2347449 (UMLS CUI [1,2])
Patient Participating Identifier Number
Item
Participating Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI [1,1])
C2347449 (UMLS CUI [1,2])
Comments
Item
COMMENTS
text
C0947611 (UMLS CUI [1])
Item Group
Disease Description - Prior History
C0455458 (UMLS CUI-1)
Primary Tumor Diagnosis Date
Item
Date of definitive histologic diagnosis of primary tumor
date
C3262 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C4296634 (UMLS CUI [1,1])
Item
Stage (at diagnosis FIGO)
text
C1300072 (UMLS CUI [1])
Code List
Stage (at diagnosis FIGO)
CL Item
FIGO Stage I  (I)
C3272671 (UMLS CUI-1)
CL Item
FIGO Stage II (II)
C3272679 (UMLS CUI-1)
CL Item
FIGO Stage III (III)
C3272682 (UMLS CUI-1)
CL Item
FIGO Stage IV (IV)
C3272688 (UMLS CUI-1)
Primary Surgery Date
Item
Primary surgery date
date
C1628561 (UMLS CUI [1])
Item
Primary surgery type (check all that apply)
integer
Code List
Primary surgery type (check all that apply)
CL Item
Partial Hysterectomy (1)
C1270947 (UMLS CUI-1)
CL Item
Radical Hysterectomy (2)
C2987682 (UMLS CUI-1)
CL Item
Total Hysterectomy (3)
C0677962 (UMLS CUI-1)
CL Item
Radical Trachelectomy (4)
C2095755 (UMLS CUI-1)
CL Item
Bilateral Salpingo-oophorectomy (5)
C0195495 (UMLS CUI-1)
CL Item
Unilateral Salpingo-oophorectomy (6)
C0041692 (UMLS CUI-1)
CL Item
Omentectomy (7)
C0198614 (UMLS CUI-1)
CL Item
Cervical Conization (8)
C0195324 (UMLS CUI-1)
CL Item
Para-aortic Node Sampling/dissection (9)
C0843590 (UMLS CUI-1)
C4038875 (UMLS CUI-2)
CL Item
Pelvic Node Sampling/dissection (10)
C0843588 (UMLS CUI-1)
C0193883 (UMLS CUI-2)
CL Item
Other, Specify (11)
C0205394 (UMLS CUI-1)
Primary Surgery
Item
Other (Primary Surgery Type), specify
text
C0543467 (UMLS CUI [1])
Item Group
Disease Description - Current History
C0262926 (UMLS CUI-1)
Item
Current status of disease
text
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Current status of disease
CL Item
Primary Gyn Disease Continues To Be Present Following Initial Treatment (Persistent)
C2983415 (UMLS CUI-1)
CL Item
Recurrence Of Same Gyn Disease Previously Treated Successfully (Recurrence)
C0034897 (UMLS CUI-1)
CL Item
Progression Of Gyn Disease Per Recist Criteria (Progression)
C0242656 (UMLS CUI-1)
CL Item
Primary Tumor (Primary (advanced stage))
C0677930 (UMLS CUI-1)
Progression Date, First
Item
Date of first recurrence or progression
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
What was the method used to determine progression? (recurrence or check all that apply)
integer
C0242656 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Code List
What was the method used to determine progression? (recurrence or check all that apply)
CL Item
Histology (1)
C0019638 (UMLS CUI-1)
CL Item
Radiographic (2)
C0444708 (UMLS CUI-1)
CL Item
Clinical Examination (3)
C1456356 (UMLS CUI-1)
Item
Site(s) of disease (at study entry check all that apply)
integer
C3262 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
C12971 (NCI Thesaurus ObjectClass-2)
C1290853 (UMLS CUI [1])
Code List
Site(s) of disease (at study entry check all that apply)
CL Item
Ascites (1)
C0003962 (UMLS CUI-1)
CL Item
Bladder (2)
C0005682 (UMLS CUI-1)
CL Item
Bone (3)
C0262950 (UMLS CUI-1)
CL Item
Cervix (4)
C0007874 (UMLS CUI-1)
CL Item
Colon (5)
C0009368 (UMLS CUI-1)
CL Item
CNS/Brain (6)
C3714787 (UMLS CUI-1)
CL Item
Endometrium (7)
C0014180 (UMLS CUI-1)
CL Item
Liver (8)
C0023884 (UMLS CUI-1)
CL Item
Lung (9)
C0024109 (UMLS CUI-1)
CL Item
Lymph nodes (10)
C0024204 (UMLS CUI-1)
CL Item
Ovary (11)
C0029939 (UMLS CUI-1)
CL Item
Parametrial involvement (12)
C0227822 (UMLS CUI-1)
CL Item
Peritoneum (13)
C0031153 (UMLS CUI-1)
CL Item
Pleura (14)
C0032225 (UMLS CUI-1)
CL Item
Pleural effusion (15)
C0032227 (UMLS CUI-1)
CL Item
Skin (16)
C1123023 (UMLS CUI-1)
CL Item
Uterus (17)
C0042149 (UMLS CUI-1)
CL Item
Other, specify (18)
C3845569 (UMLS CUI-1)
Disease Site, other
Item
Other (Sites of Disease), specify
text
C1290853 (UMLS CUI [1])
Item Group
Prior Treatment For Gynecologic Cancer
C1514463 (UMLS CUI-1)
C0699889 (UMLS CUI-2)
Prior Chemotherapy
Item
Prior systemic chemotherapy?
boolean
C1514457 (UMLS CUI [1])
Prior Chemotherapy Begin Date
Item
Date prior chemotherapy started
date
C1514457 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Prior Chemotherapy End Date
Item
Date prior chemotherapy ended
date
C1514457 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Chemotherapy regimen
integer
C1514457 (UMLS CUI [1])
Code List
Chemotherapy regimen
CL Item
First Line Agent (1)
C2045825 (UMLS CUI-1)
CL Item
Second Line Agent (2)
C2045828 (UMLS CUI-1)
CL Item
Other, Specify (3)
C3845569 (UMLS CUI-1)
Second line Chemotherapy
Item
Second line chemotherapy, specify agent(s)
text
C2045828 (UMLS CUI [1])
Prior Chemotherapy, other
Item
Other, specify agent(s)
text
C1514457 (UMLS CUI [1])
Chemotherapy, number of cycles
Item
No. of courses
integer
C2045831 (UMLS CUI [1])
Prior Hormonal Therapy
Item
Prior hormonal therapy?
boolean
C1514460 (UMLS CUI [1])
Prior Hormonal Therapy Type
Item
Yes (Prior Hormonal), specify
text
C1514460 (UMLS CUI [1])
Biological Response Modifier Therapy
Item
Non-protocol biologic response modifier (BRM)?
boolean
C0005527 (UMLS CUI [1])
BRM, non-protocol
Item
Yes, (Non-protocol BRM) specify
text
C25590 (NCI Thesaurus ObjectClass)
C2167 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0005527 (UMLS CUI [1,1])
C1518384 (UMLS CUI [1,2])
Item
Prior radiation therapy?
text
Code List
Prior radiation therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes, specify)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Non-Protocol radiotherapy
Item
Yes, (Prior RT) specify
text
C0279134 (UMLS CUI [1,1])
C1518384 (UMLS CUI [1,2])
Recurrence Site treated by radiation therapy
Item
Is the site of recurrence within the field previously treated by radiation therapy?
boolean
C0034897 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])

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