Informationen:
Fehler:
ID
26884
Beschreibung
A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2-Positive Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00950300
Link
https://clinicaltrials.gov/show/NCT00950300
Stichworte
Versionen (1)
- 27.10.17 27.10.17 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
27. Oktober 2017
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00950300
Eligibility Breast Cancer NCT00950300
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Breast Cancer NCT00950300
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Adult | Gender | Age
Item
adult women >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Breast adenocarcinoma Invasive Primary TNM Breast tumor staging | Inflammatory Breast Carcinoma | Multicentric Breast Carcinoma | Tumor size | HER2-positive carcinoma of breast
Item
non-metastatic primary invasive adenocarcinoma of the breast clinical stage i-iiic, including inflammatory and multicentric breast cancer, tumour size >/= 1 cm, histologically confirmed, her2-positive
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
C0278601 (UMLS CUI [2])
C2986664 (UMLS CUI [3])
C0475440 (UMLS CUI [4])
C1960398 (UMLS CUI [5])
C0205281 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
C0278601 (UMLS CUI [2])
C2986664 (UMLS CUI [3])
C0475440 (UMLS CUI [4])
C1960398 (UMLS CUI [5])
Measurable lesion Quantity Breast | Measurable lesion Quantity Lymph nodes | Exception Inflammatory carcinoma
Item
at least 1 measurable lesion in breast or lymph nodes according to recist v1.0 criteria, except for inflammatory carcinoma
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0024204 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0334385 (UMLS CUI [3,2])
C1265611 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0024204 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0334385 (UMLS CUI [3,2])
Left ventricular ejection fraction
Item
baseline lvef >/= 55%
boolean
C0428772 (UMLS CUI [1])
Invasive carcinoma of breast Ipsilateral | Invasive carcinoma of breast Contralateral
Item
history of any prior (ipsi- and/or contralateral) invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
C0441989 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Anthracyclines
Item
any prior therapy with anthracyclines
boolean
C0282564 (UMLS CUI [1])
Therapeutic procedure HER2 Targeted | Biological treatment | Immunotherapy
Item
prior anti-her2 therapy or biologic or immunotherapy
boolean
C0087111 (UMLS CUI [1,1])
C0242957 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0242957 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Heart Disease Serious
Item
serious cardiac illness
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])