ID

39119

Description

The Prone Breast Radiation Therapy Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01815476

Link

https://clinicaltrials.gov/show/NCT01815476

Keywords

  1. 12/2/19 12/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 2, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Ductal Carcinoma In Situ NCT01815476

Eligibility Ductal Carcinoma In Situ NCT01815476

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (dcis);
Description

Breast Carcinoma | DCIS

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0007124
treated with bct;
Description

Breast-Conserving Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0917927
no indication for treatment of regional ln;
Description

Absence Indication Treatment Regional lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1179441
women with a bra size of 40 inches or greater, or a pre-surgery cup size of d or greater
Description

Gender | Bra Size | Breast size pre-surgery

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0453881
UMLS CUI [2,2]
C0456389
UMLS CUI [3,1]
C0425782
UMLS CUI [3,2]
C0441943
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
regional lymph node xrt indicated;
Description

Indication X-ray beam therapy Regional lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0436209
UMLS CUI [1,3]
C1179441
bilateral breast cancer;
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
unhealed wound (skin not closed and/or infection);
Description

Wound, non-healed | Open wound of skin | Infection

Data type

boolean

Alias
UMLS CUI [1]
C0750433
UMLS CUI [2]
C4551350
UMLS CUI [3]
C3714514
previous xrt to the same breast;
Description

X-ray beam therapy Previous Breast Same

Data type

boolean

Alias
UMLS CUI [1,1]
C0436209
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0445247
unable to lie prone;
Description

Lacking Able to lie down Prone

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0033422
presence of active connective tissue disease;
Description

Connective Tissue Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009782
pregnancy;
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the prescribed dose, i.e. v25gy > 10%);
Description

Heart Exposure Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C1883420
adequate coverage of postoperative tumour bed not technically possible
Description

Coverage Unsuccessful Tumor Bed Postoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C1999244
UMLS CUI [1,2]
C1272705
UMLS CUI [1,3]
C3640144
UMLS CUI [1,4]
C0032790

Similar models

Eligibility Ductal Carcinoma In Situ NCT01815476

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | DCIS
Item
confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (dcis);
boolean
C0678222 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
Breast-Conserving Therapy
Item
treated with bct;
boolean
C0917927 (UMLS CUI [1])
Absence Indication Treatment Regional lymph nodes
Item
no indication for treatment of regional ln;
boolean
C0332197 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1179441 (UMLS CUI [1,4])
Gender | Bra Size | Breast size pre-surgery
Item
women with a bra size of 40 inches or greater, or a pre-surgery cup size of d or greater
boolean
C0079399 (UMLS CUI [1])
C0453881 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0425782 (UMLS CUI [3,1])
C0441943 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Indication X-ray beam therapy Regional lymph nodes
Item
regional lymph node xrt indicated;
boolean
C3146298 (UMLS CUI [1,1])
C0436209 (UMLS CUI [1,2])
C1179441 (UMLS CUI [1,3])
Bilateral breast cancer
Item
bilateral breast cancer;
boolean
C0281267 (UMLS CUI [1])
Wound, non-healed | Open wound of skin | Infection
Item
unhealed wound (skin not closed and/or infection);
boolean
C0750433 (UMLS CUI [1])
C4551350 (UMLS CUI [2])
C3714514 (UMLS CUI [3])
X-ray beam therapy Previous Breast Same
Item
previous xrt to the same breast;
boolean
C0436209 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0445247 (UMLS CUI [1,4])
Lacking Able to lie down Prone
Item
unable to lie prone;
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0033422 (UMLS CUI [1,3])
Connective Tissue Disease
Item
presence of active connective tissue disease;
boolean
C0009782 (UMLS CUI [1])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Heart Exposure Unacceptable
Item
unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the prescribed dose, i.e. v25gy > 10%);
boolean
C0018787 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C1883420 (UMLS CUI [1,3])
Coverage Unsuccessful Tumor Bed Postoperative
Item
adequate coverage of postoperative tumour bed not technically possible
boolean
C1999244 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C3640144 (UMLS CUI [1,3])
C0032790 (UMLS CUI [1,4])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial