Eligibility Breast Cancer NCT01463007

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StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT01463007

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Breast Cancer NCT01463007