ID

38241

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02213991

Nyckelord

Versioner (1)
  1. 2019-10-01 2019-10-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 oktober 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT02213991

Engelsk

Eligibility Breast Cancer NCT02213991

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Breast Carcinoma Operable | Neoplasm Metastasis Absent

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

Age | Gender | ECOG performance status

Datatyp

boolean

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

Operation on breast Illicit | Exception Biopsy

Datatyp

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
Beskrivning

Gender | DCIS | Biopsy Preoperative

Datatyp

boolean

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

Exclusion Criteria

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

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Datatyp

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
Beskrivning

Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

Depth Neoplasm Skin | Measurement Ultrasonography

Datatyp

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
Beskrivning

Medical contraindication Breast-Conserving Surgery

Datatyp

boolean

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

Multicentric Breast Carcinoma

Datatyp

boolean

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

Microcalcification Diffuse Malignant

Datatyp

boolean

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

Prior radiation therapy Breast

Datatyp

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
Beskrivning

Small breast | Clear Margin Lacking

Datatyp

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
Beskrivning

Collagen-vascular disease | Scleroderma | Lupus Erythematosus

Datatyp

boolean

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

Exclusion Criteria Postoperative

Datatyp

boolean

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

Reexcision Required | Etiology Resection margins Positive

Datatyp

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
Beskrivning

Depth Cavity Skin | Status post Segmental Mastectomy

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT02213991

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial