ID

26063

Beschreibung

A Pilot Study to Evaluate the Safety and Activities of EW02 in Reducing Neutropenia Caused by Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00555516

Link

https://clinicaltrials.gov/show/NCT00555516

Stichworte

Versionen (1)
  1. 05.10.17 05.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Oktober 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00555516

Englisch

Eligibility Breast Cancer NCT00555516

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed informed consent obtained prior to inclusion in study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. pathologically confirmed breast cancer, whose cbc has shown ever dropped unto 1,000 to 3,000/mm3 in wbc count, or unto 500 to 1,500/mm3 in anc count, on day 8 or day 15, whilst on cycle 1 of current chemotherapy.
Beschreibung

Breast Carcinoma | Complete Blood Count | White Blood Cell Count procedure | Absolute neutrophil count | Chemotherapy cycle

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0009555
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0948762
UMLS CUI [5]
C1302181
3. age 20 - 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. stage t 1-3, n 0-2, m0.
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
5. ecog performance status of < 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. chemotherapy regimen is restricted to one of the followings:
Beschreibung

Chemotherapy Regimen Restricted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0443288
(1)doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2(ac x 4cycles) or (2)cyclophosphamide 500 mg/m2 + doxorubicin 50 mg/m2 + 5-fu 500 mg/m2 (caf x 6 cycles) 7.laboratory test results within 30 days prior to study entry:
Beschreibung

Doxorubicin | Cyclophosphamide | Adriamycin | Fluorouracil | Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1]
C0013089
UMLS CUI [2]
C0010583
UMLS CUI [3]
C0085752
UMLS CUI [4]
C0013089
UMLS CUI [5]
C0016360
UMLS CUI [6]
C1254595
1. hemoglobin 9.0 g/dl for men and 8.7 g/dl for women and platelet> 100,000/mm³ without the need for current, on-going use of erythropoietin or transfusion
Beschreibung

Hemoglobin measurement | Gender | Platelet Count measurement | Erythropoietin Continuous Redundant | Transfusion Continuous Redundant

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C0014822
UMLS CUI [4,2]
C0549178
UMLS CUI [4,3]
C1313915
UMLS CUI [5,1]
C0005841
UMLS CUI [5,2]
C0549178
UMLS CUI [5,3]
C1313915
2. normal liver function (got < 1.5 x uln)
Beschreibung

Liver function | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
3. normal kidney function (creatinine < 1.5 x uln) and no dialysis. 8.negative of mandatory pregnancy test for women subjects.
Beschreibung

Renal function | Creatinine measurement, serum | Dialysis procedure Absent | Gender Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0011946
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women under pregnancy or with positive result from mandatory pregnancy test or in lactating; women of child-bearing potential must use adequate contraception
Beschreibung

Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
2. prior systemic therapy or radiotherapy for breast cancer
Beschreibung

Systemic therapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0678222
3. known hypersensitivity to bean products
Beschreibung

Allergy to bean

Datentyp

boolean

Alias
UMLS CUI [1]
C2227748
4. serious medical or psychiatric illness that, in the opinion of the principal investigator, would interfere with the ability to adhere to study requirements.
Beschreibung

Illness Serious Interferes with Protocol Compliance | Mental disorder Serious Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
5. history of myocardial infraction or angina.
Beschreibung

Myocardial Infarction | Angina Pectoris

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002962
6. uncontrollable acute or chronic diseases, including hypertension or diabetes.
Beschreibung

Disease Uncontrolled | Chronic disease Uncontrolled | Uncontrolled hypertension | Diabetic - poor control

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0421258
7. second malignancy or cancer metastasis
Beschreibung

Neoplasms, Second Primary | Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0027627
8. hbv or hcv carrier
Beschreibung

carrier of type B viral hepatitis | Hepatitis C carrier

Datentyp

boolean

Alias
UMLS CUI [1]
C2025297
UMLS CUI [2]
C0400920
9. wbc below 4000 or anc below 2000 on d1 of cycle 1
Beschreibung

White Blood Cell Count procedure | Absolute neutrophil count | Chemotherapy cycle

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C1302181
10. participation in investigational drug study within the past 30 days
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Breast Cancer NCT00555516

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed informed consent obtained prior to inclusion in study
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma | Complete Blood Count | White Blood Cell Count procedure | Absolute neutrophil count | Chemotherapy cycle
Item
2. pathologically confirmed breast cancer, whose cbc has shown ever dropped unto 1,000 to 3,000/mm3 in wbc count, or unto 500 to 1,500/mm3 in anc count, on day 8 or day 15, whilst on cycle 1 of current chemotherapy.
boolean
C0678222 (UMLS CUI [1])
C0009555 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C1302181 (UMLS CUI [5])
Age
Item
3. age 20 - 70 years
boolean
C0001779 (UMLS CUI [1])
TNM clinical staging
Item
4. stage t 1-3, n 0-2, m0.
boolean
C3258246 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status of < 2
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Regimen Restricted
Item
6. chemotherapy regimen is restricted to one of the followings:
boolean
C0392920 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Doxorubicin | Cyclophosphamide | Adriamycin | Fluorouracil | Laboratory Results
Item
(1)doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2(ac x 4cycles) or (2)cyclophosphamide 500 mg/m2 + doxorubicin 50 mg/m2 + 5-fu 500 mg/m2 (caf x 6 cycles) 7.laboratory test results within 30 days prior to study entry:
boolean
C0013089 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0085752 (UMLS CUI [3])
C0013089 (UMLS CUI [4])
C0016360 (UMLS CUI [5])
C1254595 (UMLS CUI [6])
Hemoglobin measurement | Gender | Platelet Count measurement | Erythropoietin Continuous Redundant | Transfusion Continuous Redundant
Item
1. hemoglobin 9.0 g/dl for men and 8.7 g/dl for women and platelet> 100,000/mm³ without the need for current, on-going use of erythropoietin or transfusion
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0014822 (UMLS CUI [4,1])
C0549178 (UMLS CUI [4,2])
C1313915 (UMLS CUI [4,3])
C0005841 (UMLS CUI [5,1])
C0549178 (UMLS CUI [5,2])
C1313915 (UMLS CUI [5,3])
Liver function | Aspartate aminotransferase measurement
Item
2. normal liver function (got < 1.5 x uln)
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Renal function | Creatinine measurement, serum | Dialysis procedure Absent | Gender Pregnancy test negative
Item
3. normal kidney function (creatinine < 1.5 x uln) and no dialysis. 8.negative of mandatory pregnancy test for women subjects.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0011946 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods
Item
1. women under pregnancy or with positive result from mandatory pregnancy test or in lactating; women of child-bearing potential must use adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Systemic therapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma
Item
2. prior systemic therapy or radiotherapy for breast cancer
boolean
C1515119 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Allergy to bean
Item
3. known hypersensitivity to bean products
boolean
C2227748 (UMLS CUI [1])
Illness Serious Interferes with Protocol Compliance | Mental disorder Serious Interferes with Protocol Compliance
Item
4. serious medical or psychiatric illness that, in the opinion of the principal investigator, would interfere with the ability to adhere to study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Myocardial Infarction | Angina Pectoris
Item
5. history of myocardial infraction or angina.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
Disease Uncontrolled | Chronic disease Uncontrolled | Uncontrolled hypertension | Diabetic - poor control
Item
6. uncontrollable acute or chronic diseases, including hypertension or diabetes.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1868885 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
Neoplasms, Second Primary | Neoplasm Metastasis
Item
7. second malignancy or cancer metastasis
boolean
C0085183 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
carrier of type B viral hepatitis | Hepatitis C carrier
Item
8. hbv or hcv carrier
boolean
C2025297 (UMLS CUI [1])
C0400920 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count | Chemotherapy cycle
Item
9. wbc below 4000 or anc below 2000 on d1 of cycle 1
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C1302181 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in investigational drug study within the past 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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