ID

41162

Beschreibung

Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01); ODM derived from: https://clinicaltrials.gov/show/NCT01329640

Link

https://clinicaltrials.gov/show/NCT01329640

Stichworte

Versionen (1)
  1. 03.07.20 03.07.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Juli 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Locally Advanced HER2-positive Breast Cancer NCT01329640

Englisch

Eligibility Locally Advanced HER2-positive Breast Cancer NCT01329640

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of locally advanced breast cancer
Beschreibung

Locally advanced breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C3495949
t > 2 cm (any n), or any t and positive node(needle biopsy is required if tumor size is less than 2cm)
Beschreibung

Tumor size | Positive Lymph Node | Needle biopsy Required

Datentyp

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2]
C0746319
UMLS CUI [3,1]
C0005560
UMLS CUI [3,2]
C1514873
non-metastatic disease confirmed by computerized tomography and bone scan
Beschreibung

Disease Without Neoplasm Metastasis | Computed Tomography | Bone scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0027627
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0203668
her2 positive by ihc (+++) and/or fish (+) according to international definitions (asco 2007)
Beschreibung

HER2 Positive Immunohistochemistry | HER2 Positive FISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C2348909
UMLS CUI [2,2]
C0162789
normal left ventricular ejection fraction (lvef)
Beschreibung

Left ventricular ejection fraction Normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
indication of preoperative chemotherapy
Beschreibung

Indication Preoperative Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347669
multifocal tumors acceptable provided that the largest tumor is her2-positive
Beschreibung

Multifocal tumor Acceptable | Neoplasm Largest HER2 Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302461
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0443228
UMLS CUI [2,3]
C2348909
ecog 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
Beschreibung

Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Ductal carcinoma in situ of breast | Exception Curative treatment Lobular carcinoma in situ of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007124
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0279563
clinically significant comorbidities such as cardiovascular diseases, copd, renal or liver impairment, psychiatric disorders
Beschreibung

Comorbidity Clinical Significance | Cardiovascular Diseases | Chronic Obstructive Airway Disease | Renal Insufficiency | Hepatic impairment | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0024117
UMLS CUI [4]
C1565489
UMLS CUI [5]
C0948807
UMLS CUI [6]
C0004936
lvef value below institutional limits of normal range
Beschreibung

Left ventricular ejection fraction decreased

Datentyp

boolean

Alias
UMLS CUI [1]
C1096403
detected or suspected distant metastasis
Beschreibung

Distant metastasis | Distant metastasis Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0750491
neutrophils lower than 1,500/µl, platelets lower than 100,000/µl, hemoglobin lower than 10 g/dl, ast higher than 2.5x upper limit of normal (uln), total bilirubin higher than uln, alkaline phosphatase more than 1.5x uln
Beschreibung

Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate Aminotransferase Increased | SERUM TOTAL BILIRUBIN ELEVATED | Alkaline phosphatase raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0595866
UMLS CUI [6]
C0151849
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Ähnliche Modelle

Eligibility Locally Advanced HER2-positive Breast Cancer NCT01329640

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer
Item
diagnosis of locally advanced breast cancer
boolean
C3495949 (UMLS CUI [1])
Tumor size | Positive Lymph Node | Needle biopsy Required
Item
t > 2 cm (any n), or any t and positive node(needle biopsy is required if tumor size is less than 2cm)
boolean
C0475440 (UMLS CUI [1])
C0746319 (UMLS CUI [2])
C0005560 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Disease Without Neoplasm Metastasis | Computed Tomography | Bone scan
Item
non-metastatic disease confirmed by computerized tomography and bone scan
boolean
C0012634 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
C0203668 (UMLS CUI [3])
HER2 Positive Immunohistochemistry | HER2 Positive FISH
Item
her2 positive by ihc (+++) and/or fish (+) according to international definitions (asco 2007)
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C2348909 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Left ventricular ejection fraction Normal
Item
normal left ventricular ejection fraction (lvef)
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Indication Preoperative Chemotherapy
Item
indication of preoperative chemotherapy
boolean
C3146298 (UMLS CUI [1,1])
C2347669 (UMLS CUI [1,2])
Multifocal tumor Acceptable | Neoplasm Largest HER2 Positive
Item
multifocal tumors acceptable provided that the largest tumor is her2-positive
boolean
C1302461 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0443228 (UMLS CUI [2,2])
C2348909 (UMLS CUI [2,3])
ECOG performance status
Item
ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Ductal carcinoma in situ of breast | Exception Curative treatment Lobular carcinoma in situ of breast
Item
another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007124 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0279563 (UMLS CUI [5,3])
Comorbidity Clinical Significance | Cardiovascular Diseases | Chronic Obstructive Airway Disease | Renal Insufficiency | Hepatic impairment | Mental disorders
Item
clinically significant comorbidities such as cardiovascular diseases, copd, renal or liver impairment, psychiatric disorders
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0948807 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
Left ventricular ejection fraction decreased
Item
lvef value below institutional limits of normal range
boolean
C1096403 (UMLS CUI [1])
Distant metastasis | Distant metastasis Suspected
Item
detected or suspected distant metastasis
boolean
C1269798 (UMLS CUI [1])
C1269798 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate Aminotransferase Increased | SERUM TOTAL BILIRUBIN ELEVATED | Alkaline phosphatase raised
Item
neutrophils lower than 1,500/µl, platelets lower than 100,000/µl, hemoglobin lower than 10 g/dl, ast higher than 2.5x upper limit of normal (uln), total bilirubin higher than uln, alkaline phosphatase more than 1.5x uln
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0595866 (UMLS CUI [5])
C0151849 (UMLS CUI [6])
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