ID

38201

Description

Intraoperative Radiation Therapy in Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02266602

Link

https://clinicaltrials.gov/show/NCT02266602

Keywords

Versions (1)
  1. 9/26/19 9/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02266602

English

Eligibility Breast Cancer NCT02266602

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion criteria
Description

Inclusion criteria General

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
1. age ≥ 45 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. clinical stage tis, t1, t2 (≤ 3cm), n0, m0 (ajcc classification).
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
3. invasive ductal or lobular carcinoma, dcis and/ or pleomorphic lobular carcinoma in situ.
Description

Invasive Ductal Breast Carcinoma | Invasive Lobular Breast Carcinoma | DCIS | Pleomorphic lobular carcinoma in situ

Data type

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C0279565
UMLS CUI [3]
C0007124
UMLS CUI [4]
C2919327
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. scleroderma, systemic sclerosis and active lupus.
Description

Scleroderma | Systemic Sclerosis | Lupus Erythematosus

Data type

boolean

Alias
UMLS CUI [1]
C0011644
UMLS CUI [2]
C0036421
UMLS CUI [3]
C0409974
2. participation in an investigational drug or device study.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
3. previous ipsilateral radiation to the thorax or breast.
Description

Prior radiation therapy Ipsilateral Chest | Prior radiation therapy Ipsilateral Breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0817096
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0441989
UMLS CUI [2,3]
C0006141
4. multifocal breast cancer.
Description

Multifocal breast carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2986662
5. pregnant patients.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
6. patient not competent to provide informed consent.
Description

Informed Consent incompetent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231190
7. neoadjuvant systemic therapy.
Description

Neoadjuvant Therapy Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0205373
8. lymphovascular invasion on biopsy pathology
Description

Lymphatic Invasion Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C1708790
UMLS CUI [1,2]
C0005558
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Similar models

Eligibility Breast Cancer NCT02266602

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria General
Item
general inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Age
Item
1. age ≥ 45 years.
boolean
C0001779 (UMLS CUI [1])
TNM Breast tumor staging
Item
2. clinical stage tis, t1, t2 (≤ 3cm), n0, m0 (ajcc classification).
boolean
C0474926 (UMLS CUI [1])
Invasive Ductal Breast Carcinoma | Invasive Lobular Breast Carcinoma | DCIS | Pleomorphic lobular carcinoma in situ
Item
3. invasive ductal or lobular carcinoma, dcis and/ or pleomorphic lobular carcinoma in situ.
boolean
C1134719 (UMLS CUI [1])
C0279565 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
C2919327 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Scleroderma | Systemic Sclerosis | Lupus Erythematosus
Item
1. scleroderma, systemic sclerosis and active lupus.
boolean
C0011644 (UMLS CUI [1])
C0036421 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
2. participation in an investigational drug or device study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Prior radiation therapy Ipsilateral Chest | Prior radiation therapy Ipsilateral Breast
Item
3. previous ipsilateral radiation to the thorax or breast.
boolean
C0279134 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0817096 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
Multifocal breast carcinoma
Item
4. multifocal breast cancer.
boolean
C2986662 (UMLS CUI [1])
Pregnancy
Item
5. pregnant patients.
boolean
C0032961 (UMLS CUI [1])
Informed Consent incompetent
Item
6. patient not competent to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0231190 (UMLS CUI [1,2])
Neoadjuvant Therapy Systemic
Item
7. neoadjuvant systemic therapy.
boolean
C0600558 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Lymphatic Invasion Biopsy
Item
8. lymphovascular invasion on biopsy pathology
boolean
C1708790 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
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