ID

38127

Description

A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01791829

Lien

https://clinicaltrials.gov/show/NCT01791829

Mots-clés

Versions (1)
  1. 20/09/2019 20/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 septembre 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01791829

Anglais

Eligibility Breast Cancer NCT01791829

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patient > or = 55 years of age with a new diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous only) with primary tumour < or =2cm on microscopic exam, with no evidence of metastatic disease;
Description

Gender | Age | Invasive carcinoma of breast | Invasive Ductal Breast Carcinoma | Tubular breast carcinoma | Mucinous carcinoma of breast | Tumor size Microscopy | Neoplasm Metastasis Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0853879
UMLS CUI [4]
C1134719
UMLS CUI [5]
C1328544
UMLS CUI [6]
C1334807
UMLS CUI [7,1]
C0475440
UMLS CUI [7,2]
C0026018
UMLS CUI [8,1]
C0027627
UMLS CUI [8,2]
C0332197
2. er positive (> or =1%) and pr positive (>20%) and her2 negative (immunohistochemical (ihc) or in situ hybridization (ish) approach);
Description

Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry | HER2 Negative Immunohistochemistry | Estrogen receptor positive In Situ Hybridization | Progesterone receptor positive In Situ Hybridization | HER2 Negative In Situ Hybridization

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279754
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0279759
UMLS CUI [2,2]
C0021044
UMLS CUI [3,1]
C2348908
UMLS CUI [3,2]
C0021044
UMLS CUI [4,1]
C0279754
UMLS CUI [4,2]
C0162788
UMLS CUI [5,1]
C0279759
UMLS CUI [5,2]
C0162788
UMLS CUI [6,1]
C2348908
UMLS CUI [6,2]
C0162788
3. treated by bcs with microscopically clear resection margins > or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
Description

Breast-Conserving Surgery | Surgical margins Length Microscopic | Disease Invasive | Disease Non-invasive | Reexcision | Residual disease Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2,1]
C0229985
UMLS CUI [2,2]
C1444754
UMLS CUI [2,3]
C0205288
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205281
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205303
UMLS CUI [5]
C0184913
UMLS CUI [6,1]
C0543478
UMLS CUI [6,2]
C0332197
4. negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.
Description

Axillary Lymph Node Involvement Negative Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes

Type de données

boolean

Alias
UMLS CUI [1,1]
C0741343
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0796693
UMLS CUI [2]
C0193867
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinical or pathological evidence of t4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
Description

Disease TNM Breast tumor staging | Extension Chest wall | Skin Involvement | Peau d'orange | Inflammatory Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0231448
UMLS CUI [2,2]
C0205076
UMLS CUI [3,1]
C1123023
UMLS CUI [3,2]
C1314939
UMLS CUI [4]
C0425791
UMLS CUI [5]
C0278601
2. multifocal or multicentric disease.
Description

Disease Multifocal | Disease Multicentric

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205292
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0439743
3. evidence of an extensive intraductal component (defined as a tumour that is composed of 25% or more of dcis and the dcis extends beyond the gross dimensions of the tumour), or disease limited to micro invasion only.
Description

Intraductal tumor configuration Extensive | Tumor Percentage DCIS | Disease Only microinvasion present

Type de données

boolean

Alias
UMLS CUI [1,1]
C1276434
UMLS CUI [1,2]
C0205231
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0007124
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C4489121
4. grade 3 histology for invasive disease
Description

Disease Invasive Histology grade

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C1317415
5. evidence of lymphovascular invasion.
Description

Lymphatic Invasion

Type de données

boolean

Alias
UMLS CUI [1]
C1708790
6. evidence of disease on pre-operative mammogram, aside from primary cancer treated by breast conserving surgery.
Description

Disease Mammography Preoperative | Breast-Conserving Surgery Primary tumor

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0024671
UMLS CUI [1,3]
C0445204
UMLS CUI [2,1]
C0917927
UMLS CUI [2,2]
C0677930
7. bilateral malignancy of the breast (synchronous or metachronous).
Description

Bilateral breast cancer Synchronous | Bilateral breast cancer

Type de données

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C0439580
UMLS CUI [2]
C0281267
8. known brca 1 or 2 mutations.
Description

BRCA1 gene mutation | BRCA2 gene mutation

Type de données

boolean

Alias
UMLS CUI [1]
C1511022
UMLS CUI [2]
C1511024
9. history of non-breast cancer malignancies if not disease free for > 5 years and considered low risk of recurrence with the exception of treated carcinoma in-situ of the cervix, endometrium or colon, melanoma in-situ and basal or squamous cell carcinoma of the skin.
Description

Malignant Neoplasms | Exception Breast Carcinoma | Exception Disease Free Duration | Exception Low Risk Recurrence | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of endometrium Treated | Exception Colon Carcinoma Treated | Exception Malignant melanoma in situ Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3538919
UMLS CUI [4,3]
C0034897
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0346191
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0699790
UMLS CUI [7,3]
C1522326
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0854696
UMLS CUI [8,3]
C1522326
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0007117
UMLS CUI [9,3]
C1522326
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0553723
UMLS CUI [10,3]
C1522326
10. serious non-malignant disease associated with a life expectancy < 10 years.
Description

Disease Serious | Exception Malignant Neoplasm | Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [3]
C0023671
11. inability to be treated with or to tolerate endocrine therapy.
Description

Hormone Therapy Receive Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
12. psychiatric or addictive disorder, which would preclude obtaining informed consent or adherence to protocol.
Description

Mental disorder Excludes Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorder Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0085281
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0525058
13. geographic inaccessibility for follow-up.
Description

Unavailability Follow-up | Etiology Geographic Factors

Type de données

boolean

Alias
UMLS CUI [1,1]
C0686905
UMLS CUI [1,2]
C3274571
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0017444
14. inability to understand or unable to provide written informed consent.
Description

Informed Consent Comprehension Unable | Informed Consent Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
15. inability to be registered on study within 12 weeks of the last surgical procedure on the breast.
Description

Enrollment Unable | Time Period Operation on breast Last

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C1948053
UMLS CUI [2,2]
C3714726
UMLS CUI [2,3]
C1517741
16. central testing for ki67 > 13.25% consistent with the luminal b subtype
Description

Ki67 Measurement Consistent with Luminal B Subtype of Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C4049944
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C3642346
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Similar models

Eligibility Breast Cancer NCT01791829

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Invasive carcinoma of breast | Invasive Ductal Breast Carcinoma | Tubular breast carcinoma | Mucinous carcinoma of breast | Tumor size Microscopy | Neoplasm Metastasis Absent
Item
1. female patient > or = 55 years of age with a new diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous only) with primary tumour < or =2cm on microscopic exam, with no evidence of metastatic disease;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0853879 (UMLS CUI [3])
C1134719 (UMLS CUI [4])
C1328544 (UMLS CUI [5])
C1334807 (UMLS CUI [6])
C0475440 (UMLS CUI [7,1])
C0026018 (UMLS CUI [7,2])
C0027627 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry | HER2 Negative Immunohistochemistry | Estrogen receptor positive In Situ Hybridization | Progesterone receptor positive In Situ Hybridization | HER2 Negative In Situ Hybridization
Item
2. er positive (> or =1%) and pr positive (>20%) and her2 negative (immunohistochemical (ihc) or in situ hybridization (ish) approach);
boolean
C0279754 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0279759 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C2348908 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C0279754 (UMLS CUI [4,1])
C0162788 (UMLS CUI [4,2])
C0279759 (UMLS CUI [5,1])
C0162788 (UMLS CUI [5,2])
C2348908 (UMLS CUI [6,1])
C0162788 (UMLS CUI [6,2])
Breast-Conserving Surgery | Surgical margins Length Microscopic | Disease Invasive | Disease Non-invasive | Reexcision | Residual disease Absent
Item
3. treated by bcs with microscopically clear resection margins > or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
boolean
C0917927 (UMLS CUI [1])
C0229985 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C0205288 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205303 (UMLS CUI [4,2])
C0184913 (UMLS CUI [5])
C0543478 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Axillary Lymph Node Involvement Negative Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes
Item
4. negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.
boolean
C0741343 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
C0193867 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Disease TNM Breast tumor staging | Extension Chest wall | Skin Involvement | Peau d'orange | Inflammatory Breast Carcinoma
Item
1. clinical or pathological evidence of t4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0231448 (UMLS CUI [2,1])
C0205076 (UMLS CUI [2,2])
C1123023 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0425791 (UMLS CUI [4])
C0278601 (UMLS CUI [5])
Disease Multifocal | Disease Multicentric
Item
2. multifocal or multicentric disease.
boolean
C0012634 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0439743 (UMLS CUI [2,2])
Intraductal tumor configuration Extensive | Tumor Percentage DCIS | Disease Only microinvasion present
Item
3. evidence of an extensive intraductal component (defined as a tumour that is composed of 25% or more of dcis and the dcis extends beyond the gross dimensions of the tumour), or disease limited to micro invasion only.
boolean
C1276434 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0007124 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C4489121 (UMLS CUI [3,2])
Disease Invasive Histology grade
Item
4. grade 3 histology for invasive disease
boolean
C0012634 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1317415 (UMLS CUI [1,3])
Lymphatic Invasion
Item
5. evidence of lymphovascular invasion.
boolean
C1708790 (UMLS CUI [1])
Disease Mammography Preoperative | Breast-Conserving Surgery Primary tumor
Item
6. evidence of disease on pre-operative mammogram, aside from primary cancer treated by breast conserving surgery.
boolean
C0012634 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0917927 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
Bilateral breast cancer Synchronous | Bilateral breast cancer
Item
7. bilateral malignancy of the breast (synchronous or metachronous).
boolean
C0281267 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C0281267 (UMLS CUI [2])
BRCA1 gene mutation | BRCA2 gene mutation
Item
8. known brca 1 or 2 mutations.
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Disease Free Duration | Exception Low Risk Recurrence | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of endometrium Treated | Exception Colon Carcinoma Treated | Exception Malignant melanoma in situ Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
9. history of non-breast cancer malignancies if not disease free for > 5 years and considered low risk of recurrence with the exception of treated carcinoma in-situ of the cervix, endometrium or colon, melanoma in-situ and basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C3538919 (UMLS CUI [4,2])
C0034897 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0346191 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0699790 (UMLS CUI [7,2])
C1522326 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0854696 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0007117 (UMLS CUI [9,2])
C1522326 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0553723 (UMLS CUI [10,2])
C1522326 (UMLS CUI [10,3])
Disease Serious | Exception Malignant Neoplasm | Life Expectancy
Item
10. serious non-malignant disease associated with a life expectancy < 10 years.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Hormone Therapy Receive Unable
Item
11. inability to be treated with or to tolerate endocrine therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Mental disorder Excludes Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorder Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance
Item
12. psychiatric or addictive disorder, which would preclude obtaining informed consent or adherence to protocol.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0085281 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Unavailability Follow-up | Etiology Geographic Factors
Item
13. geographic inaccessibility for follow-up.
boolean
C0686905 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0017444 (UMLS CUI [2,2])
Informed Consent Comprehension Unable | Informed Consent Unable
Item
14. inability to understand or unable to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Enrollment Unable | Time Period Operation on breast Last
Item
15. inability to be registered on study within 12 weeks of the last surgical procedure on the breast.
boolean
C1516879 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1948053 (UMLS CUI [2,1])
C3714726 (UMLS CUI [2,2])
C1517741 (UMLS CUI [2,3])
Ki67 Measurement Consistent with Luminal B Subtype of Breast Carcinoma
Item
16. central testing for ki67 > 13.25% consistent with the luminal b subtype
boolean
C4049944 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C3642346 (UMLS CUI [1,3])
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