ID

38082

Description

The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01634984

Lien

https://clinicaltrials.gov/show/NCT01634984

Mots-clés

  1. 16/09/2019 16/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 septembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01634984

Eligibility Breast Cancer NCT01634984

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. pathological confirmation of breast cancer
Description

Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0678222
3. tumor stage(tnm):t2-4bn0-3m0
Description

TNM Breast tumor staging

Type de données

boolean

Alias
UMLS CUI [1]
C0474926
4. er(+) and/or pr(+).
Description

Estrogen receptor positive | Progesterone receptor positive

Type de données

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
5. premenopausal woman.
Description

Premenopausal state

Type de données

boolean

Alias
UMLS CUI [1]
C0232969
6. age≥40 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
7. measurable disease as per recist criteria
Description

Measurable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
8. karnofsky≥70
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
9. laboratory criteria:
Description

Laboratory criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
plt≥100*109/l
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
wbc≥4000/mm3
Description

White Blood Cell Count procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0023508
hgb≥10g/dl
Description

Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
alt and ast<2*uln
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of metastatic disease.
Description

Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1]
C0027627
2. inflammatory breast cancer.
Description

Inflammatory Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0278601
3. bilateral breast cancer.
Description

Bilateral breast cancer

Type de données

boolean

Alias
UMLS CUI [1]
C0281267
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
Description

Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0678222
5. other malignant tumor (concurrent or previous).
Description

Cancer Other

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
6. pregnant woman.
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
7. hypersensitive to any drug in cef regimen or any ingredient of zoladex.
Description

Hypersensitivity Pharmaceutical Preparation CEF regimen | Hypersensitivity Ingredient Zoladex

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0248241
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1550600
UMLS CUI [2,3]
C0149473
8. any severe systemic disease contraindicating chemotherapy.
Description

Systemic disease Severe | Medical contraindication Chemotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0392920

Similar models

Eligibility Breast Cancer NCT01634984

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma
Item
2. pathological confirmation of breast cancer
boolean
C0678222 (UMLS CUI [1])
TNM Breast tumor staging
Item
3. tumor stage(tnm):t2-4bn0-3m0
boolean
C0474926 (UMLS CUI [1])
Estrogen receptor positive | Progesterone receptor positive
Item
4. er(+) and/or pr(+).
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
Premenopausal state
Item
5. premenopausal woman.
boolean
C0232969 (UMLS CUI [1])
Age
Item
6. age≥40 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
7. measurable disease as per recist criteria
boolean
C1513041 (UMLS CUI [1])
Karnofsky Performance Status
Item
8. karnofsky≥70
boolean
C0206065 (UMLS CUI [1])
Laboratory criteria
Item
9. laboratory criteria:
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Platelet Count measurement
Item
plt≥100*109/l
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc≥4000/mm3
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement
Item
hgb≥10g/dl
boolean
C0518015 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt and ast<2*uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
1. presence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
2. inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
Bilateral breast cancer
Item
3. bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1])
Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma
Item
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Cancer Other
Item
5. other malignant tumor (concurrent or previous).
boolean
C1707251 (UMLS CUI [1])
Pregnancy
Item
6. pregnant woman.
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity Pharmaceutical Preparation CEF regimen | Hypersensitivity Ingredient Zoladex
Item
7. hypersensitive to any drug in cef regimen or any ingredient of zoladex.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0248241 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C0149473 (UMLS CUI [2,3])
Systemic disease Severe | Medical contraindication Chemotherapy
Item
8. any severe systemic disease contraindicating chemotherapy.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])

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