ID

38151

Beschreibung

A Biomarker Study in Patients With HER2-negative Metastatic Breast Cancer Treated With Bevacizumab and Paclitaxel; ODM derived from: https://clinicaltrials.gov/show/NCT01722968

Link

https://clinicaltrials.gov/show/NCT01722968

Stichworte

Versionen (1)
  1. 22.09.19 22.09.19 -
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See clinicaltrials.gov

Hochgeladen am

22. September 2019

DOI

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Eligibility Breast Cancer NCT01722968

Englisch

Eligibility Breast Cancer NCT01722968

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18-70 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. performance status ecog 0-2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
3. clinically and / or radiologically proven stage iv or recurrent her2 negative breast cancer.
Beschreibung

Breast Carcinoma HER2 Negative TNM Breast tumor staging | Breast cancer recurrent HER2 Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C2348908
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C2348908
4. at least one tumor lesion accessible for biopsy. this lesion may not have been treated previously with irradiation.
Beschreibung

Tumor Lesion Quantity | Lesion suitable Biopsy | Therapeutic radiology procedure Absent Lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0005558
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0221198
5. clinically and/or radiographically documented measurable disease according to recist v1.1 criteria. at least one site of disease must be unidimensionally measurable as follows:
Beschreibung

Measurable Disease | Site Quantity Measurable Linear

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1513040
UMLS CUI [2,4]
C0205132
1. ct-scan, physical exam ≥ 10 mm} chest x-ray ≥ 20 mm }see eisenhauer et al. for more details
Beschreibung

Site Length CT scan | Site Length Physical Examination | Site Length Chest X-ray

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C1444754
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C1444754
UMLS CUI [2,3]
C0031809
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C1444754
UMLS CUI [3,3]
C0039985
2. lymph node short axis ≥ 15 mm }
Beschreibung

Site Length Lymph node Short axis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C1444754
UMLS CUI [1,3]
C0024204
UMLS CUI [1,4]
C0522488
3. all radiology studies must be performed within 28 days prior to registration (35 days if negative).
Beschreibung

Radiology studies

Datentyp

boolean

Alias
UMLS CUI [1]
C0807679
6. adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:
Beschreibung

Bone Marrow function | Liver function | Renal function | Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0022885
1. haematology: absolute granulocytes > 1.5 x 109/l platelets > 100 x 109/l
Beschreibung

Hematology | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
2. biochemistry:bilirubin within normal limits serum creatinine within normal limits
Beschreibung

Biochemistry finding | Serum bilirubin normal | Serum creatinine normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0428132
UMLS CUI [2]
C0428443
UMLS CUI [3]
C0438244
7. aptt and inr within normal limits within 7 days prior to enrollment.
Beschreibung

Activated partial thromboplastin time normal | INR normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0853632
UMLS CUI [2]
C0580416
8. adequate cardiac function with left ventricular ejection fraction (lvef) within normal limits determined by echocardiogram or muga within 28 days prior to inclusion.
Beschreibung

Cardiac function | Left ventricular ejection fraction Normal Echocardiography | Left ventricular ejection fraction Normal MUGA scan

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0205307
UMLS CUI [2,3]
C0013516
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0205307
UMLS CUI [3,3]
C0521317
9. written informed consent must be given.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous systemic treatment for mbc.
Beschreibung

Systemic therapy Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0346993
2. major surgery less than 28 days prior to enrollment.
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
3. concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
Beschreibung

Cancer Other | Exception Basal cell carcinoma Limited Controlled | Exception Squamous cell carcinoma of skin Limited Controlled | Exception Carcinoma in situ of uterine cervix Limited Controlled

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C2587213
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C2587213
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C0439801
UMLS CUI [4,4]
C2587213
4. bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
Beschreibung

Bleeding tendency | Thromboembolism | Warfarin | Heparin Analogs | Antiplatelet Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0040038
UMLS CUI [3]
C0043031
UMLS CUI [4,1]
C0019134
UMLS CUI [4,2]
C0243071
UMLS CUI [5]
C0085826
5. major cardiac comorbidity.
Beschreibung

Comorbidity cardiac major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0205164
6. previous treatment with bevacizumab.
Beschreibung

Bevacizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0796392
7. previous allergic reaction to taxane analogs.
Beschreibung

Allergic Reaction Taxane Analogs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0215136
UMLS CUI [1,3]
C0243071
8. ongoing pregnancy or lactation.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Beschreibung

Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Follow-up | Factor Familial Interferes with Protocol Compliance | Factor Familial Interferes with Follow-up | Sociological Factors Interfere with Protocol Compliance | Sociological Factors Interfere with Follow-up | Geographic Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0241888
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C1521761
UMLS CUI [4,2]
C0241888
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C3274571
UMLS CUI [5,1]
C3850138
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C3850138
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C3274571
UMLS CUI [7,1]
C0017444
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0017444
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C3274571
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Ähnliche Modelle

Eligibility Breast Cancer NCT01722968

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18-70 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. performance status ecog 0-2.
boolean
C1520224 (UMLS CUI [1])
Breast Carcinoma HER2 Negative TNM Breast tumor staging | Breast cancer recurrent HER2 Negative
Item
3. clinically and / or radiologically proven stage iv or recurrent her2 negative breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0278493 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
Tumor Lesion Quantity | Lesion suitable Biopsy | Therapeutic radiology procedure Absent Lesion
Item
4. at least one tumor lesion accessible for biopsy. this lesion may not have been treated previously with irradiation.
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0221198 (UMLS CUI [3,3])
Measurable Disease | Site Quantity Measurable Linear
Item
5. clinically and/or radiographically documented measurable disease according to recist v1.1 criteria. at least one site of disease must be unidimensionally measurable as follows:
boolean
C1513041 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C0205132 (UMLS CUI [2,4])
Site Length CT scan | Site Length Physical Examination | Site Length Chest X-ray
Item
1. ct-scan, physical exam ≥ 10 mm} chest x-ray ≥ 20 mm }see eisenhauer et al. for more details
boolean
C1515974 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3,1])
C1444754 (UMLS CUI [3,2])
C0039985 (UMLS CUI [3,3])
Site Length Lymph node Short axis
Item
2. lymph node short axis ≥ 15 mm }
boolean
C1515974 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
C0522488 (UMLS CUI [1,4])
Radiology studies
Item
3. all radiology studies must be performed within 28 days prior to registration (35 days if negative).
boolean
C0807679 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | Laboratory Procedures
Item
6. adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
Hematology | Absolute neutrophil count | Platelet Count measurement
Item
1. haematology: absolute granulocytes > 1.5 x 109/l platelets > 100 x 109/l
boolean
C0200627 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Biochemistry finding | Serum bilirubin normal | Serum creatinine normal
Item
2. biochemistry:bilirubin within normal limits serum creatinine within normal limits
boolean
C0428132 (UMLS CUI [1])
C0428443 (UMLS CUI [2])
C0438244 (UMLS CUI [3])
Activated partial thromboplastin time normal | INR normal
Item
7. aptt and inr within normal limits within 7 days prior to enrollment.
boolean
C0853632 (UMLS CUI [1])
C0580416 (UMLS CUI [2])
Cardiac function | Left ventricular ejection fraction Normal Echocardiography | Left ventricular ejection fraction Normal MUGA scan
Item
8. adequate cardiac function with left ventricular ejection fraction (lvef) within normal limits determined by echocardiogram or muga within 28 days prior to inclusion.
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0013516 (UMLS CUI [2,3])
C0428772 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0521317 (UMLS CUI [3,3])
Informed Consent
Item
9. written informed consent must be given.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Secondary malignant neoplasm of female breast
Item
1. previous systemic treatment for mbc.
boolean
C1515119 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
Major surgery
Item
2. major surgery less than 28 days prior to enrollment.
boolean
C0679637 (UMLS CUI [1])
Cancer Other | Exception Basal cell carcinoma Limited Controlled | Exception Squamous cell carcinoma of skin Limited Controlled | Exception Carcinoma in situ of uterine cervix Limited Controlled
Item
3. concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C2587213 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C2587213 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C2587213 (UMLS CUI [4,4])
Bleeding tendency | Thromboembolism | Warfarin | Heparin Analogs | Antiplatelet Agents
Item
4. bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
boolean
C1458140 (UMLS CUI [1])
C0040038 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0019134 (UMLS CUI [4,1])
C0243071 (UMLS CUI [4,2])
C0085826 (UMLS CUI [5])
Comorbidity cardiac major
Item
5. major cardiac comorbidity.
boolean
C0009488 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
Bevacizumab
Item
6. previous treatment with bevacizumab.
boolean
C0796392 (UMLS CUI [1])
Allergic Reaction Taxane Analogs
Item
7. previous allergic reaction to taxane analogs.
boolean
C1527304 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C0243071 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
8. ongoing pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Follow-up | Factor Familial Interferes with Protocol Compliance | Factor Familial Interferes with Follow-up | Sociological Factors Interfere with Protocol Compliance | Sociological Factors Interfere with Follow-up | Geographic Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Follow-up
Item
9. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C1521761 (UMLS CUI [4,1])
C0241888 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
C3850138 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C3850138 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0017444 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C3274571 (UMLS CUI [8,3])
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