ID

16294

Description

Radiation Dose Intensity Study in Breast Cancer in Young Women; ODM derived from: https://clinicaltrials.gov/show/NCT00212121

Link

https://clinicaltrials.gov/show/NCT00212121

Keywords

Versions (1)
  1. 7/10/16 7/10/16 -
Uploaded on

July 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00212121

English

Eligibility Breast Cancer NCT00212121

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 50 years or younger.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
Description

histological diagnosis of invasive mammary cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0853879
tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
Description

tumor location and extension imaging

Data type

boolean

Alias
UMLS CUI [1]
C0027653
UMLS CUI [2]
C0024671
UMLS CUI [3]
C0080264
unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:
Description

Resection margin

Data type

boolean

Alias
UMLS CUI [1,1]
C0191863
UMLS CUI [1,2]
C1705057
any dcis or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
Description

Histology of resection biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0006142
sentinel lymph node biopsy and/or axillary lymph node dissection has been performed.
Description

sentinel lymph node biopsy and/or axillary lymph node dissection

Data type

boolean

Alias
UMLS CUI [1]
C0796693
UMLS CUI [2]
C0193867
breast cancer stage: pt1-2pn0-2a m0.
Description

breast cancer stage

Data type

boolean

Alias
UMLS CUI [1]
C2216702
no treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy).
Description

Preoperative treatment

Data type

boolean

Alias
UMLS CUI [1]
C1960751
in cases where no adjuvant chemotherapy is given, wide local excision has been performed < 10 weeks before the start of radiotherapy.
Description

wide local excision

Data type

boolean

Alias
UMLS CUI [1]
C2986517
in cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed < 6 months before the start of radiotherapy, and chemotherapy should be completed < 6 weeks before the start of radiotherapy.
Description

wide local excision

Data type

boolean

Alias
UMLS CUI [1]
C2986517
in cases where hormonal treatment is planned, this is given after completion of the radiotherapy.
Description

Hormonal treatment after radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522449
no previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Description

Other malignant tumor or disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0559147
UMLS CUI [1,2]
C0009488
ecog performance scale 2 or less.
Description

ecog performance scale

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
residual microcalcifications on mammogram.
Description

residual microcalcifications

Data type

boolean

Alias
UMLS CUI [1]
C2830589
all histological types of malignancies other than invasive adenocarcinoma.
Description

histological types of malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0027652
in situ carcinoma of the breast, without invasive tumor.
Description

in situ carcinoma of the breast

Data type

boolean

Alias
UMLS CUI [1]
C1276756
concurrent pregnancy.
Description

concurrent pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0549206
multicentric tumors, and multifocal. tumors excised using multiple excisions *
Description

multicentric tumors, and multifocal. tumors excised using multiple excisions

Data type

boolean

Alias
UMLS CUI [1]
C2986664
UMLS CUI [2]
C2986662
UMLS CUI [3]
C0191863
invasive breast cancer in both breasts.
Description

invasive breast cancer in both breasts.

Data type

boolean

Alias
UMLS CUI [1]
C0281267
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Similar models

Eligibility Breast Cancer NCT00212121

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 50 years or younger.
boolean
C0001779 (UMLS CUI [1])
histological diagnosis of invasive mammary cancer
Item
histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
boolean
C0679557 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
tumor location and extension imaging
Item
tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
boolean
C0027653 (UMLS CUI [1])
C0024671 (UMLS CUI [2])
C0080264 (UMLS CUI [3])
Resection margin
Item
unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:
boolean
C0191863 (UMLS CUI [1,1])
C1705057 (UMLS CUI [1,2])
Histology of resection biopsy
Item
any dcis or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
boolean
C0344441 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
sentinel lymph node biopsy and/or axillary lymph node dissection
Item
sentinel lymph node biopsy and/or axillary lymph node dissection has been performed.
boolean
C0796693 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
breast cancer stage
Item
breast cancer stage: pt1-2pn0-2a m0.
boolean
C2216702 (UMLS CUI [1])
Preoperative treatment
Item
no treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy).
boolean
C1960751 (UMLS CUI [1])
wide local excision
Item
in cases where no adjuvant chemotherapy is given, wide local excision has been performed < 10 weeks before the start of radiotherapy.
boolean
C2986517 (UMLS CUI [1])
wide local excision
Item
in cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed < 6 months before the start of radiotherapy, and chemotherapy should be completed < 6 weeks before the start of radiotherapy.
boolean
C2986517 (UMLS CUI [1])
Hormonal treatment after radiotherapy
Item
in cases where hormonal treatment is planned, this is given after completion of the radiotherapy.
boolean
C0279025 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Other malignant tumor or disease
Item
no previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
boolean
C0559147 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
ecog performance scale
Item
ecog performance scale 2 or less.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
residual microcalcifications
Item
residual microcalcifications on mammogram.
boolean
C2830589 (UMLS CUI [1])
histological types of malignancies
Item
all histological types of malignancies other than invasive adenocarcinoma.
boolean
C0027652 (UMLS CUI [1])
in situ carcinoma of the breast
Item
in situ carcinoma of the breast, without invasive tumor.
boolean
C1276756 (UMLS CUI [1])
concurrent pregnancy
Item
concurrent pregnancy.
boolean
C0549206 (UMLS CUI [1])
multicentric tumors, and multifocal. tumors excised using multiple excisions
Item
multicentric tumors, and multifocal. tumors excised using multiple excisions *
boolean
C2986664 (UMLS CUI [1])
C2986662 (UMLS CUI [2])
C0191863 (UMLS CUI [3])
invasive breast cancer in both breasts.
Item
invasive breast cancer in both breasts.
boolean
C0281267 (UMLS CUI [1])
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