ID

35016

Description

Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02400658

Link

https://clinicaltrials.gov/show/NCT02400658

Keywords

Versions (1)
  1. 2/9/19 2/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02400658

English

Eligibility Breast Cancer NCT02400658

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
Description

Breast-Conserving Surgery Early-Stage Breast Carcinoma | Whole Breast Irradiation Early-Stage Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0917927
UMLS CUI [1,2]
C2986665
UMLS CUI [2,1]
C3897169
UMLS CUI [2,2]
C2986665
2. tumor size must be less than or equal to 3 cm.
Description

Tumor size

Data type

boolean

Alias
UMLS CUI [1]
C0475440
3. patient is 45 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. male patients.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
2. pregnant patients.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
3. breast cancer that involves the skin or chest wall.
Description

Breast Carcinoma Involvement Skin | Breast Carcinoma Involvement Chest wall

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1123023
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0205076
4. history of ipsilateral breast cancer.
Description

Breast Carcinoma Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0441989
5. multicentric breast cancer in the ipsilateral breast.
Description

Multicentric Breast Carcinoma Breast Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C2986664
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0441989
6. known brca gene mutation.
Description

BRCA Gene Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0596223
UMLS CUI [1,2]
C0596611
7. patient with nodal disease.
Description

Disorder of lymph node

Data type

boolean

Alias
UMLS CUI [1]
C0272394
8. patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size.
Description

Hormone Therapy Reducing Tumor size | Chemotherapy Reducing Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0475440
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0392756
UMLS CUI [2,3]
C0475440
9. patient with breast implants (does not include patients having implants after intra-operative radiotherapy).
Description

Breast implants

Data type

boolean

Alias
UMLS CUI [1]
C0179412
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Similar models

Eligibility Breast Cancer NCT02400658

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast-Conserving Surgery Early-Stage Breast Carcinoma | Whole Breast Irradiation Early-Stage Breast Carcinoma
Item
1. patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
boolean
C0917927 (UMLS CUI [1,1])
C2986665 (UMLS CUI [1,2])
C3897169 (UMLS CUI [2,1])
C2986665 (UMLS CUI [2,2])
Tumor size
Item
2. tumor size must be less than or equal to 3 cm.
boolean
C0475440 (UMLS CUI [1])
Age
Item
3. patient is 45 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender
Item
1. male patients.
boolean
C0079399 (UMLS CUI [1])
Pregnancy
Item
2. pregnant patients.
boolean
C0032961 (UMLS CUI [1])
Breast Carcinoma Involvement Skin | Breast Carcinoma Involvement Chest wall
Item
3. breast cancer that involves the skin or chest wall.
boolean
C0678222 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0205076 (UMLS CUI [2,3])
Breast Carcinoma Ipsilateral
Item
4. history of ipsilateral breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
Multicentric Breast Carcinoma Breast Ipsilateral
Item
5. multicentric breast cancer in the ipsilateral breast.
boolean
C2986664 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
BRCA Gene Mutation
Item
6. known brca gene mutation.
boolean
C0596223 (UMLS CUI [1,1])
C0596611 (UMLS CUI [1,2])
Disorder of lymph node
Item
7. patient with nodal disease.
boolean
C0272394 (UMLS CUI [1])
Hormone Therapy Reducing Tumor size | Chemotherapy Reducing Tumor size
Item
8. patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size.
boolean
C0279025 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0475440 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C0475440 (UMLS CUI [2,3])
Breast implants
Item
9. patient with breast implants (does not include patients having implants after intra-operative radiotherapy).
boolean
C0179412 (UMLS CUI [1])
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