ID

38241

Beschreibung

Intraoperative Radiotherapy for Korean Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02213991

Link

https://clinicaltrials.gov/show/NCT02213991

Stichworte

Versionen (1)
  1. 01.10.19 01.10.19 -
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See clinicaltrials.gov

Hochgeladen am

1. Oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02213991

Englisch

Eligibility Breast Cancer NCT02213991

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed and newly diagnosed non-metastatic operable primary breast cancer
Beschreibung

Breast Carcinoma Operable | Neoplasm Metastasis Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205188
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
primary tumor <5cm, measured by ultrasonography - n0-3 (any n if resectable) and no evidence of distant metastasis (m) (isolated supraclavicular node involvement allowed)
Beschreibung

Primary tumor size Ultrasonography | TNM Breast tumor staging | Distant metastasis Absent | Supraclavicular lymph node Involvement allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0041618
UMLS CUI [2]
C0474926
UMLS CUI [3,1]
C1269798
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0229730
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0683607
age ≥18-years women with good performance status (ecog 0-1)
Beschreibung

Age | Gender | ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C1520224
no breast operation is allowed except diagnostic biopsy
Beschreibung

Operation on breast Illicit | Exception Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0332266
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
women with ductal carcinoma in situ diagnosed by preoperative biopsy are allowed
Beschreibung

Gender | DCIS | Biopsy Preoperative

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0007124
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0445204
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
Beschreibung

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
patients who received prior chemotherapy or radiotherapy for breast cancer
Beschreibung

Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0678222
patients who have history of cancer other than in situ uterine cervix cancer or non-melanoma skin cancer
Beschreibung

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
the depth of tumor from skin measured by ultrasonography is less than 1cm.
Beschreibung

Depth Neoplasm Skin | Measurement Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205125
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C1123023
UMLS CUI [2,1]
C0242485
UMLS CUI [2,2]
C0041618
contraindications to breast conservative surgery
Beschreibung

Medical contraindication Breast-Conserving Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0917927
multicentric breast cancer (tumors in more than one quadrant)
Beschreibung

Multicentric Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2986664
diffuse malignant appearing microcalcification
Beschreibung

Microcalcification Diffuse Malignant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521174
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C0205282
prior therapeutic radiation to the breast region
Beschreibung

Prior radiation therapy Breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0006141
small breast, which is not possible to achieve clear margins in relation to a cosmetically acceptable result
Beschreibung

Small breast | Clear Margin Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0425785
UMLS CUI [2,1]
C1709157
UMLS CUI [2,2]
C0332268
history of collagen vascular disease, such as active scleroderma and active lupus
Beschreibung

Collagen-vascular disease | Scleroderma | Lupus Erythematosus

Datentyp

boolean

Alias
UMLS CUI [1]
C0262428
UMLS CUI [2]
C0011644
UMLS CUI [3]
C0409974
postoperative exclusion
Beschreibung

Exclusion Criteria Postoperative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0032790
patients who require re-excision due to positive resection margin
Beschreibung

Reexcision Required | Etiology Resection margins Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184913
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0229985
UMLS CUI [2,3]
C1514241
the depth of cavity from skin after lumpectomy is less than 0.5cm
Beschreibung

Depth Cavity Skin | Status post Segmental Mastectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205125
UMLS CUI [1,2]
C1510420
UMLS CUI [1,3]
C1123023
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0024885
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Ähnliche Modelle

Eligibility Breast Cancer NCT02213991

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Operable | Neoplasm Metastasis Absent
Item
histologically confirmed and newly diagnosed non-metastatic operable primary breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Primary tumor size Ultrasonography | TNM Breast tumor staging | Distant metastasis Absent | Supraclavicular lymph node Involvement allowed
Item
primary tumor <5cm, measured by ultrasonography - n0-3 (any n if resectable) and no evidence of distant metastasis (m) (isolated supraclavicular node involvement allowed)
boolean
C0677930 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0474926 (UMLS CUI [2])
C1269798 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0229730 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Age | Gender | ECOG performance status
Item
age ≥18-years women with good performance status (ecog 0-1)
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C1520224 (UMLS CUI [3])
Operation on breast Illicit | Exception Biopsy
Item
no breast operation is allowed except diagnostic biopsy
boolean
C3714726 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Gender | DCIS | Biopsy Preoperative
Item
women with ductal carcinoma in situ diagnosed by preoperative biopsy are allowed
boolean
C0079399 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma
Item
patients who received prior chemotherapy or radiotherapy for breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma
Item
patients who have history of cancer other than in situ uterine cervix cancer or non-melanoma skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Depth Neoplasm Skin | Measurement Ultrasonography
Item
the depth of tumor from skin measured by ultrasonography is less than 1cm.
boolean
C0205125 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,3])
C0242485 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
Medical contraindication Breast-Conserving Surgery
Item
contraindications to breast conservative surgery
boolean
C1301624 (UMLS CUI [1,1])
C0917927 (UMLS CUI [1,2])
Multicentric Breast Carcinoma
Item
multicentric breast cancer (tumors in more than one quadrant)
boolean
C2986664 (UMLS CUI [1])
Microcalcification Diffuse Malignant
Item
diffuse malignant appearing microcalcification
boolean
C0521174 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,3])
Prior radiation therapy Breast
Item
prior therapeutic radiation to the breast region
boolean
C0279134 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
Small breast | Clear Margin Lacking
Item
small breast, which is not possible to achieve clear margins in relation to a cosmetically acceptable result
boolean
C0425785 (UMLS CUI [1])
C1709157 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Collagen-vascular disease | Scleroderma | Lupus Erythematosus
Item
history of collagen vascular disease, such as active scleroderma and active lupus
boolean
C0262428 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
Exclusion Criteria Postoperative
Item
postoperative exclusion
boolean
C0680251 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
Reexcision Required | Etiology Resection margins Positive
Item
patients who require re-excision due to positive resection margin
boolean
C0184913 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0229985 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Depth Cavity Skin | Status post Segmental Mastectomy
Item
the depth of cavity from skin after lumpectomy is less than 0.5cm
boolean
C0205125 (UMLS CUI [1,1])
C1510420 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0024885 (UMLS CUI [2,2])
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