ID

16294

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00212121

Trefwoorden

  1. 10-07-16 10-07-16 -
Geüploaded op

10 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00212121

Eligibility Breast Cancer NCT00212121

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 50 years or younger.
Beschrijving

Age

Datatype

boolean

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

histological diagnosis of invasive mammary cancer

Datatype

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.
Beschrijving

tumor location and extension imaging

Datatype

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:
Beschrijving

Resection margin

Datatype

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).
Beschrijving

Histology of resection biopsy

Datatype

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.
Beschrijving

sentinel lymph node biopsy and/or axillary lymph node dissection

Datatype

boolean

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

breast cancer stage

Datatype

boolean

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

Preoperative treatment

Datatype

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.
Beschrijving

wide local excision

Datatype

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.
Beschrijving

wide local excision

Datatype

boolean

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

Hormonal treatment after radiotherapy

Datatype

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.
Beschrijving

Other malignant tumor or disease

Datatype

boolean

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

ecog performance scale

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
residual microcalcifications on mammogram.
Beschrijving

residual microcalcifications

Datatype

boolean

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

histological types of malignancies

Datatype

boolean

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

in situ carcinoma of the breast

Datatype

boolean

Alias
UMLS CUI [1]
C1276756
concurrent pregnancy.
Beschrijving

concurrent pregnancy

Datatype

boolean

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

multicentric tumors, and multifocal. tumors excised using multiple excisions

Datatype

boolean

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

invasive breast cancer in both breasts.

Datatype

boolean

Alias
UMLS CUI [1]
C0281267

Similar models

Eligibility Breast Cancer NCT00212121

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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