ID

16246

Description

Accelerated Radiotherapy Outcomes in Women; ODM derived from: https://clinicaltrials.gov/show/NCT00156130

Link

https://clinicaltrials.gov/show/NCT00156130

Keywords

Versions (1)
  1. 7/7/16 7/7/16 -
Uploaded on

July 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00156130

English

Eligibility Breast Cancer NCT00156130

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
Description

Gender | Invasive carcinoma of breast | Metastatic Neoplasm No evidence

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0853879
UMLS CUI [3,1]
C2939420
UMLS CUI [3,2]
C0332125
2. has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
Description

Segmental Mastectomy | Segmentectomy | Excision Malignant Neoplasms | Normal Tissue Part

Data type

boolean

Alias
UMLS CUI [1]
C0024885
UMLS CUI [2]
C2987624
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C0006826
UMLS CUI [4]
C1519525
3. patient has not had an axillary dissection, or for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
Description

Excision of axillary lymph nodes | Metastatic Neoplasm | Negative Lymph Node

Data type

boolean

Alias
UMLS CUI [1]
C0193867
UMLS CUI [2]
C2939420
UMLS CUI [3]
C0678034
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. tumour greater than 5 cm in greatest diameter on pathological examination.
Description

Tumor size Diameter | Physical Examination Pathological aspects

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0205469
2. the presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
Description

Invasive carcinoma of breast | Noninfiltrating Intraductal Carcinoma | Surgical margin involved by tumor

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0332649
3. clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
Description

Operative Surgical Procedure Before | Skin Infiltration Breast Involvement | Edema | Ulceration | Malignant Neoplasm Fixed Muscle below | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332152
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C0332448
UMLS CUI [2,3]
C0006141
UMLS CUI [2,4]
C1314939
UMLS CUI [3]
C0013604
UMLS CUI [4]
C3887532
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C3714578
UMLS CUI [5,3]
C0026845
UMLS CUI [5,4]
C0542339
UMLS CUI [6]
C0278601
4. bilateral malignancy of the breast (synchronous or metachronous).
Description

bilateral breast cancer Synchronous | bilateral breast cancer Metachronous

Data type

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C0439580
UMLS CUI [2,1]
C0281267
UMLS CUI [2,2]
C1334703
5. more than one primary invasive tumour in the same breast.
Description

Invasive carcinoma of breast Multiple Breast Same

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0445247
6. previous surgery for breast cancer.
Description

Operative Surgical Procedure Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
7. pathological status of axilla is unknown.
Description

Axilla Status Pathological Unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0004454
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1521733
UMLS CUI [1,4]
C0439673
8. status for adjuvant systemic therapy not determined.
Description

systemic therapy Adjuvant Status Undetermined

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C3536725
9. for patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
Description

Chemotherapy, Adjuvant | Therapeutic radiology procedure Unable | Operation on breast

Data type

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1299582
UMLS CUI [3]
C3714726
10. for patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
Description

Chemotherapy, Adjuvant | Therapeutic radiology procedure Unable During Chemotherapy Time last dose

Data type

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1299582
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0392920
UMLS CUI [2,5]
C0946444
11. serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
Description

Disease Non-Malignant Serious Preventing Operative Surgical Procedures | Disease Non-Malignant Serious Preventing Therapeutic radiology procedure | Cardiovascular Diseases | Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518371
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C1292733
UMLS CUI [1,5]
C0543467
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1518371
UMLS CUI [2,3]
C0205404
UMLS CUI [2,4]
C1292733
UMLS CUI [2,5]
C1522449
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0022658
12. currently pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
Description

Breast size Inappropriate Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0425782
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1522449
14. previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma in situ of the cervix which have been effectively treated.
Description

Malignant Neoplasms | Squamous cell carcinoma of skin Treated | Basal cell carcinoma Treated | Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0553723
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
15. geographic inaccessibility for follow-up.
Description

Follow-up Patient unavailable Geographic Factors

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1301818
UMLS CUI [1,3]
C0017444
16. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Description

Mental disorders Informed Consent Unable | Substance Dependence Informed Consent Unable | Mental disorders Compliance behavior Limited | Substance Dependence Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1321605
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0038580
UMLS CUI [4,2]
C1321605
UMLS CUI [4,3]
C0439801
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Similar models

Eligibility Breast Cancer NCT00156130

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Gender | Invasive carcinoma of breast | Metastatic Neoplasm No evidence
Item
1. the female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C2939420 (UMLS CUI [3,1])
C0332125 (UMLS CUI [3,2])
Segmental Mastectomy | Segmentectomy | Excision Malignant Neoplasms | Normal Tissue Part
Item
2. has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
boolean
C0024885 (UMLS CUI [1])
C2987624 (UMLS CUI [2])
C0728940 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1519525 (UMLS CUI [4])
Excision of axillary lymph nodes | Metastatic Neoplasm | Negative Lymph Node
Item
3. patient has not had an axillary dissection, or for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
boolean
C0193867 (UMLS CUI [1])
C2939420 (UMLS CUI [2])
C0678034 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Tumor size Diameter | Physical Examination Pathological aspects
Item
1. tumour greater than 5 cm in greatest diameter on pathological examination.
boolean
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0205469 (UMLS CUI [2,2])
Invasive carcinoma of breast | Noninfiltrating Intraductal Carcinoma | Surgical margin involved by tumor
Item
2. the presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
boolean
C0853879 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C0332649 (UMLS CUI [3])
Operative Surgical Procedure Before | Skin Infiltration Breast Involvement | Edema | Ulceration | Malignant Neoplasm Fixed Muscle below | Inflammatory Breast Carcinoma
Item
3. clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
boolean
C0543467 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1123023 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
C1314939 (UMLS CUI [2,4])
C0013604 (UMLS CUI [3])
C3887532 (UMLS CUI [4])
C0006826 (UMLS CUI [5,1])
C3714578 (UMLS CUI [5,2])
C0026845 (UMLS CUI [5,3])
C0542339 (UMLS CUI [5,4])
C0278601 (UMLS CUI [6])
bilateral breast cancer Synchronous | bilateral breast cancer Metachronous
Item
4. bilateral malignancy of the breast (synchronous or metachronous).
boolean
C0281267 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C0281267 (UMLS CUI [2,1])
C1334703 (UMLS CUI [2,2])
Invasive carcinoma of breast Multiple Breast Same
Item
5. more than one primary invasive tumour in the same breast.
boolean
C0853879 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0445247 (UMLS CUI [1,4])
Operative Surgical Procedure Breast Carcinoma
Item
6. previous surgery for breast cancer.
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Axilla Status Pathological Unknown
Item
7. pathological status of axilla is unknown.
boolean
C0004454 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1521733 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
systemic therapy Adjuvant Status Undetermined
Item
8. status for adjuvant systemic therapy not determined.
boolean
C1515119 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C3536725 (UMLS CUI [1,4])
Chemotherapy, Adjuvant | Therapeutic radiology procedure Unable | Operation on breast
Item
9. for patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
boolean
C0085533 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C3714726 (UMLS CUI [3])
Chemotherapy, Adjuvant | Therapeutic radiology procedure Unable During Chemotherapy Time last dose
Item
10. for patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
boolean
C0085533 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
C0946444 (UMLS CUI [2,5])
Disease Non-Malignant Serious Preventing Operative Surgical Procedures | Disease Non-Malignant Serious Preventing Therapeutic radiology procedure | Cardiovascular Diseases | Kidney Diseases
Item
11. serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
boolean
C0012634 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C1292733 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,5])
C0012634 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C1292733 (UMLS CUI [2,4])
C1522449 (UMLS CUI [2,5])
C0007222 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
12. currently pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Breast size Inappropriate Therapeutic radiology procedure
Item
13. breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
boolean
C0425782 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
Malignant Neoplasms | Squamous cell carcinoma of skin Treated | Basal cell carcinoma Treated | Carcinoma in situ of uterine cervix Treated
Item
14. previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma in situ of the cervix which have been effectively treated.
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Follow-up Patient unavailable Geographic Factors
Item
15. geographic inaccessibility for follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C1301818 (UMLS CUI [1,2])
C0017444 (UMLS CUI [1,3])
Mental disorders Informed Consent Unable | Substance Dependence Informed Consent Unable | Mental disorders Compliance behavior Limited | Substance Dependence Compliance behavior Limited
Item
16. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
boolean
C0004936 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0038580 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0038580 (UMLS CUI [4,1])
C1321605 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
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