ID

38241

Description

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

Lien

https://clinicaltrials.gov/show/NCT02213991

Mots-clés

Versions (1)
  1. 01/10/2019 01/10/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

1 octobre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Breast Cancer NCT02213991

Anglais

Eligibility Breast Cancer NCT02213991

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Breast Carcinoma Operable | Neoplasm Metastasis Absent

Type de données

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)
Description

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

Type de données

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)
Description

Age | Gender | ECOG performance status

Type de données

boolean

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

Operation on breast Illicit | Exception Biopsy

Type de données

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
Description

Gender | DCIS | Biopsy Preoperative

Type de données

boolean

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

Exclusion Criteria

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

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Type de données

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
Description

Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma

Type de données

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
Description

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

Type de données

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.
Description

Depth Neoplasm Skin | Measurement Ultrasonography

Type de données

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
Description

Medical contraindication Breast-Conserving Surgery

Type de données

boolean

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

Multicentric Breast Carcinoma

Type de données

boolean

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

Microcalcification Diffuse Malignant

Type de données

boolean

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

Prior radiation therapy Breast

Type de données

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
Description

Small breast | Clear Margin Lacking

Type de données

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
Description

Collagen-vascular disease | Scleroderma | Lupus Erythematosus

Type de données

boolean

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

Exclusion Criteria Postoperative

Type de données

boolean

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

Reexcision Required | Etiology Resection margins Positive

Type de données

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
Description

Depth Cavity Skin | Status post Segmental Mastectomy

Type de données

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
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT02213991

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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