ID

38015

Description

Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01463007

Link

https://clinicaltrials.gov/show/NCT01463007

Keywords

Versions (1)
  1. 9/8/19 9/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01463007

English

Eligibility Breast Cancer NCT01463007

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a confirmed histological diagnosis of invasive breast carcinoma or dcis
Description

Invasive carcinoma of breast | DCIS

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0007124
2. age greater or equal to 50 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. life expectancy > 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
4. treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy
Description

Breast-Conserving Surgery | Excision of axillary lymph nodes | Sentinel Lymph Node Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2]
C0193867
UMLS CUI [3]
C0796693
5. pathologic tumor size less than or equal to 2 cm
Description

Tumor size Pathologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1521733
6. invasive ductal, mucinous, tubular or colloid histology
Description

Histology Invasive Ductal | Histology Invasive Mucinous | Histology Invasive Tubular

Data type

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C1512083
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C0205281
UMLS CUI [2,3]
C1513712
UMLS CUI [3,1]
C0344441
UMLS CUI [3,2]
C0205281
UMLS CUI [3,3]
C0332208
7. estrogen receptor positive for invasive carcinoma.
Description

Invasive Carcinoma Estrogen receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1334274
UMLS CUI [1,2]
C0279754
8. unifocal/unicentric disease
Description

Unifocal Disease | Disease Unicentric

Data type

boolean

Alias
UMLS CUI [1]
C1710542
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C4518564
9. negative surgical margins greater than or equal to 2 mm
Description

Negative Surgical Margin Length

Data type

boolean

Alias
UMLS CUI [1,1]
C1709157
UMLS CUI [1,2]
C1444754
10. pathologic lymph node negative
Description

Negative Lymph Node Pathologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0678034
UMLS CUI [1,2]
C1521733
11. no evidence of lymphovascular invasion
Description

Lymphatic Invasion Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1708790
UMLS CUI [1,2]
C0332197
12. ecog performance status of 0 or 1 (appendix 1)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
13. informed consent signed.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known brca 1/2 mutation; (brca 1 and 2 testing is not required)
Description

BRCA1 gene mutation | BRCA2 gene mutation

Data type

boolean

Alias
UMLS CUI [1]
C1511022
UMLS CUI [2]
C1511024
2. autoimmune disorder
Description

Autoimmune Disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
3. pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
4. breast implants
Description

Breast implants

Data type

boolean

Alias
UMLS CUI [1]
C0179412
5. psychiatric or addictive disorder that would preclude attending follow-up
Description

Mental disorder Excludes Follow-up | Addictive Behavior Excludes Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C3274571
6. neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
Description

Neoadjuvant Chemotherapy | Adjuvant Chemotherapy allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0683607
7. suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
Description

Breast Microcalcification Remaining Suspicious | Mammography Post Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0520594
UMLS CUI [1,2]
C1527428
UMLS CUI [1,3]
C0750493
UMLS CUI [2,1]
C0024671
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0543467
8. lobular features on histology (pure or mixed) or sarcoma histology
Description

Features Lobular Histology | Sarcoma Histology

Data type

boolean

Alias
UMLS CUI [1,1]
C1521970
UMLS CUI [1,2]
C0205417
UMLS CUI [1,3]
C0344441
UMLS CUI [2,1]
C1261473
UMLS CUI [2,2]
C0344441
9. node positive on axillary dissection or in the sentinel lymph node biopsy;
Description

Lymph node positive | Excision of axillary lymph nodes | Sentinel Lymph Node Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0746319
UMLS CUI [2]
C0193867
UMLS CUI [3]
C0796693
10. extensive in situ carcinoma (eic)
Description

Carcinoma in Situ Extensive

Data type

boolean

Alias
UMLS CUI [1,1]
C0007099
UMLS CUI [1,2]
C0205231
11. multicentric or multifocal disease
Description

Disease Multicentric | Disease Multifocal

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439743
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205292
12. paget's disease of the nipple
Description

Paget's Disease of the Nipple

Data type

boolean

Alias
UMLS CUI [1]
C1704323
13. distant metastases
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
14. lumpectomy cavity not well visualized on accuboost imaging
Description

Segmental Mastectomy Cavity | Imaging Poor

Data type

boolean

Alias
UMLS CUI [1,1]
C0024885
UMLS CUI [1,2]
C1510420
UMLS CUI [2,1]
C0079595
UMLS CUI [2,2]
C2700379
15. lumpectomy cavity with 1cm margin (ptv) not adequately encompassed by any applicator (ptv > 6cm)
Description

Segmental Mastectomy Cavity | Margin Length | Planning target volume

Data type

boolean

Alias
UMLS CUI [1,1]
C0024885
UMLS CUI [1,2]
C1510420
UMLS CUI [2,1]
C0229985
UMLS CUI [2,2]
C1444754
UMLS CUI [3]
C0454199
16. breast separation with compression > 7cm.
Description

Breast Separation Compression

Data type

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0445406
UMLS CUI [1,3]
C0728907
17. overlap of skin between orthogonal treatment axes.
Description

Overlap Skin

Data type

boolean

Alias
UMLS CUI [1,1]
C1948020
UMLS CUI [1,2]
C1123023
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Similar models

Eligibility Breast Cancer NCT01463007

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | DCIS
Item
1. a confirmed histological diagnosis of invasive breast carcinoma or dcis
boolean
C0853879 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
Age
Item
2. age greater or equal to 50 years old
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Breast-Conserving Surgery | Excision of axillary lymph nodes | Sentinel Lymph Node Biopsy
Item
4. treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy
boolean
C0917927 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
C0796693 (UMLS CUI [3])
Tumor size Pathologic
Item
5. pathologic tumor size less than or equal to 2 cm
boolean
C0475440 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
Histology Invasive Ductal | Histology Invasive Mucinous | Histology Invasive Tubular
Item
6. invasive ductal, mucinous, tubular or colloid histology
boolean
C0344441 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1512083 (UMLS CUI [1,3])
C0344441 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
C1513712 (UMLS CUI [2,3])
C0344441 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0332208 (UMLS CUI [3,3])
Invasive Carcinoma Estrogen receptor positive
Item
7. estrogen receptor positive for invasive carcinoma.
boolean
C1334274 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
Unifocal Disease | Disease Unicentric
Item
8. unifocal/unicentric disease
boolean
C1710542 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C4518564 (UMLS CUI [2,2])
Negative Surgical Margin Length
Item
9. negative surgical margins greater than or equal to 2 mm
boolean
C1709157 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Negative Lymph Node Pathologic
Item
10. pathologic lymph node negative
boolean
C0678034 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
Lymphatic Invasion Absent
Item
11. no evidence of lymphovascular invasion
boolean
C1708790 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
ECOG performance status
Item
12. ecog performance status of 0 or 1 (appendix 1)
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
13. informed consent signed.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
BRCA1 gene mutation | BRCA2 gene mutation
Item
1. known brca 1/2 mutation; (brca 1 and 2 testing is not required)
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
Autoimmune Disease
Item
2. autoimmune disorder
boolean
C0004364 (UMLS CUI [1])
Pregnancy
Item
3. pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast implants
Item
4. breast implants
boolean
C0179412 (UMLS CUI [1])
Mental disorder Excludes Follow-up | Addictive Behavior Excludes Follow-up
Item
5. psychiatric or addictive disorder that would preclude attending follow-up
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Neoadjuvant Chemotherapy | Adjuvant Chemotherapy allowed
Item
6. neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Breast Microcalcification Remaining Suspicious | Mammography Post Operative Surgical Procedures
Item
7. suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
boolean
C0520594 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
C0750493 (UMLS CUI [1,3])
C0024671 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Features Lobular Histology | Sarcoma Histology
Item
8. lobular features on histology (pure or mixed) or sarcoma histology
boolean
C1521970 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0344441 (UMLS CUI [1,3])
C1261473 (UMLS CUI [2,1])
C0344441 (UMLS CUI [2,2])
Lymph node positive | Excision of axillary lymph nodes | Sentinel Lymph Node Biopsy
Item
9. node positive on axillary dissection or in the sentinel lymph node biopsy;
boolean
C0746319 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
C0796693 (UMLS CUI [3])
Carcinoma in Situ Extensive
Item
10. extensive in situ carcinoma (eic)
boolean
C0007099 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
Disease Multicentric | Disease Multifocal
Item
11. multicentric or multifocal disease
boolean
C0012634 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
Paget's Disease of the Nipple
Item
12. paget's disease of the nipple
boolean
C1704323 (UMLS CUI [1])
Distant metastasis
Item
13. distant metastases
boolean
C1269798 (UMLS CUI [1])
Segmental Mastectomy Cavity | Imaging Poor
Item
14. lumpectomy cavity not well visualized on accuboost imaging
boolean
C0024885 (UMLS CUI [1,1])
C1510420 (UMLS CUI [1,2])
C0079595 (UMLS CUI [2,1])
C2700379 (UMLS CUI [2,2])
Segmental Mastectomy Cavity | Margin Length | Planning target volume
Item
15. lumpectomy cavity with 1cm margin (ptv) not adequately encompassed by any applicator (ptv > 6cm)
boolean
C0024885 (UMLS CUI [1,1])
C1510420 (UMLS CUI [1,2])
C0229985 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C0454199 (UMLS CUI [3])
Breast Separation Compression
Item
16. breast separation with compression > 7cm.
boolean
C0006141 (UMLS CUI [1,1])
C0445406 (UMLS CUI [1,2])
C0728907 (UMLS CUI [1,3])
Overlap Skin
Item
17. overlap of skin between orthogonal treatment axes.
boolean
C1948020 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
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