ID

40808

Beskrivning

Study of Neoadjuvant FEC Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01340430

Länk

https://clinicaltrials.gov/show/NCT01340430

Nyckelord

Versioner (1)
  1. 2020-05-17 2020-05-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility HER-2 Positive Breast Cancer NCT01340430

Engelsk

Eligibility HER-2 Positive Breast Cancer NCT01340430

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. performance status ecog 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
2. histologically confirmed invasive breast cancer,
Beskrivning

Invasive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0853879
3. primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or rmn candidate to neoadjuvant chemotherapy ,
Beskrivning

Primary tumor Diameter | Primary tumor Clinical examination | Primary tumor Mammography | Primary tumor Ultrasonography | Primary tumor MRI | Patient Appropriate Neoadjuvant Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C1456356
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C0024671
UMLS CUI [4,1]
C0677930
UMLS CUI [4,2]
C0041618
UMLS CUI [5,1]
C0677930
UMLS CUI [5,2]
C0024485
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C1548787
UMLS CUI [6,3]
C0600558
UMLS CUI [6,4]
C3665472
4. any n,
Beskrivning

Lymph nodal status Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449927
UMLS CUI [1,2]
C1552551
5. no evidence of metastasis (m0);
Beskrivning

Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
6. over expression and/or amplification of her2 in the invasive component of the primary tumour according to one of the following definitions:
Beskrivning

HER2 Overexpression Component Invasive | HER2 gene amplification Component Invasive | Component Invasive Primary tumor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0205281
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0205281
UMLS CUI [3,1]
C1705248
UMLS CUI [3,2]
C0205281
UMLS CUI [3,3]
C0677930
7. 3+ over expression by ihc (> 30% of invasive tumour cells),
Beskrivning

Overexpression Immunohistochemistry | Tumor Cell Invasive Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514559
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C0205281
UMLS CUI [2,3]
C0439165
8. 2+ or 3+ (in 30% o less neoplastic cells) overexpression by ihc and in situ hybridization (fish/cish) test demonstrating her2 gene amplication ,
Beskrivning

Overexpression Immunohistochemistry | Tumor Cell Percentage | HER2 gene amplification FISH | HER2 gene amplification CISH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514559
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C1512127
UMLS CUI [3,2]
C0162789
UMLS CUI [4,1]
C1512127
UMLS CUI [4,2]
C1516514
9. her 2 gene amplication by fish/cish (ratio > 2.2);
Beskrivning

HER2 gene amplification FISH | HER2 gene amplification CISH | Ratio measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512127
UMLS CUI [1,2]
C0162789
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C1516514
UMLS CUI [3]
C1261161
10. known hormone receptor status
Beskrivning

Hormone Receptor Status Known

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205309
11. hematopoietic status:
Beskrivning

Status Hematopoietic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0229601
1. absolute neutrophil count ≥ 1.5 x 109/l,
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count ≥ 100 x 109/l,
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
12. hepatic status:
Beskrivning

Status Hepatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0205054
1. serum total bilirubin ≤ 1.5 x uln. in the case of known gilbert's syndrome a higher serum total bilirubin (< 2 x uln) is allowed,
Beskrivning

Serum total bilirubin measurement | Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
2. ast and alt ≤ 2.5 times uln,
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
3. alkaline phosphatase ≤ 2.5 times uln;
Beskrivning

Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201850
13. renal status:
Beskrivning

Status renal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0022646
a. creatinine ≤ 2.0 mg/dl;
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
14. cardiovascular:
Beskrivning

Status Cardiovascular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C3887460
a. baseline lvef ≥ 50% measured by echocardiography or muga scan;
Beskrivning

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
15. for women of childbearing potential negative serum pregnancy test12) r. 16. written informed consent.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. male gender
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
2. pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. received any prior treatment for primary invasive breast cancer
Beskrivning

Prior Therapy Invasive carcinoma of breast Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0853879
UMLS CUI [1,3]
C0205225
4. known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
Beskrivning

Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Congestive heart failure | Transmural myocardial infarction | Uncontrolled hypertension | Blood pressure determination | Unstable diabetes mellitus | Resting Dyspnea | Oxygen Therapy chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0018802
UMLS CUI [5]
C1400513
UMLS CUI [6]
C1868885
UMLS CUI [7]
C0005824
UMLS CUI [8]
C0342302
UMLS CUI [9]
C0743330
UMLS CUI [10,1]
C0184633
UMLS CUI [10,2]
C0205191
5. active or uncontrolled infection,
Beskrivning

Communicable Disease | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
6. dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of icf,
Beskrivning

Dementia | Abnormal mental state | Mental condition Preventing Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0278061
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
7. concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
Beskrivning

Neoadjuvant Therapy Malignant Neoplasm | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Exception Investigational Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0021083
UMLS CUI [5]
C1531518
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0949266
8. previous or concomitant malignancy within the past 3 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
9. concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
Beskrivning

Comorbidity Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate | Disease Interferes with Patient safety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1113679
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Similar models

Eligibility HER-2 Positive Breast Cancer NCT01340430

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
1. performance status ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Invasive carcinoma of breast
Item
2. histologically confirmed invasive breast cancer,
boolean
C0853879 (UMLS CUI [1])
Primary tumor Diameter | Primary tumor Clinical examination | Primary tumor Mammography | Primary tumor Ultrasonography | Primary tumor MRI | Patient Appropriate Neoadjuvant Chemotherapy
Item
3. primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or rmn candidate to neoadjuvant chemotherapy ,
boolean
C0677930 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0677930 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
C0677930 (UMLS CUI [3,1])
C0024671 (UMLS CUI [3,2])
C0677930 (UMLS CUI [4,1])
C0041618 (UMLS CUI [4,2])
C0677930 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
C0030705 (UMLS CUI [6,1])
C1548787 (UMLS CUI [6,2])
C0600558 (UMLS CUI [6,3])
C3665472 (UMLS CUI [6,4])
Lymph nodal status Any
Item
4. any n,
boolean
C0449927 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Neoplasm Metastasis Absent
Item
5. no evidence of metastasis (m0);
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
HER2 Overexpression Component Invasive | HER2 gene amplification Component Invasive | Component Invasive Primary tumor
Item
6. over expression and/or amplification of her2 in the invasive component of the primary tumour according to one of the following definitions:
boolean
C1515560 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
C1512127 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0205281 (UMLS CUI [2,3])
C1705248 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0677930 (UMLS CUI [3,3])
Overexpression Immunohistochemistry | Tumor Cell Invasive Percentage
Item
7. 3+ over expression by ihc (> 30% of invasive tumour cells),
boolean
C1514559 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Overexpression Immunohistochemistry | Tumor Cell Percentage | HER2 gene amplification FISH | HER2 gene amplification CISH
Item
8. 2+ or 3+ (in 30% o less neoplastic cells) overexpression by ihc and in situ hybridization (fish/cish) test demonstrating her2 gene amplication ,
boolean
C1514559 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1512127 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
C1512127 (UMLS CUI [4,1])
C1516514 (UMLS CUI [4,2])
HER2 gene amplification FISH | HER2 gene amplification CISH | Ratio measurement
Item
9. her 2 gene amplication by fish/cish (ratio > 2.2);
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C1516514 (UMLS CUI [2,2])
C1261161 (UMLS CUI [3])
Hormone Receptor Status Known
Item
10. known hormone receptor status
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
Status Hematopoietic
Item
11. hematopoietic status:
boolean
C0449438 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. absolute neutrophil count ≥ 1.5 x 109/l,
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count ≥ 100 x 109/l,
boolean
C0032181 (UMLS CUI [1])
Status Hepatic
Item
12. hepatic status:
boolean
C0449438 (UMLS CUI [1,1])
C0205054 (UMLS CUI [1,2])
Serum total bilirubin measurement | Gilbert Disease
Item
1. serum total bilirubin ≤ 1.5 x uln. in the case of known gilbert's syndrome a higher serum total bilirubin (< 2 x uln) is allowed,
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
2. ast and alt ≤ 2.5 times uln,
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Alkaline phosphatase measurement
Item
3. alkaline phosphatase ≤ 2.5 times uln;
boolean
C0201850 (UMLS CUI [1])
Status renal
Item
13. renal status:
boolean
C0449438 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
a. creatinine ≤ 2.0 mg/dl;
boolean
C0201976 (UMLS CUI [1])
Status Cardiovascular
Item
14. cardiovascular:
boolean
C0449438 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
a. baseline lvef ≥ 50% measured by echocardiography or muga scan;
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test negative | Informed Consent
Item
15. for women of childbearing potential negative serum pregnancy test12) r. 16. written informed consent.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Gender
Item
1. male gender
boolean
C0079399 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Therapy Invasive carcinoma of breast Primary
Item
3. received any prior treatment for primary invasive breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Congestive heart failure | Transmural myocardial infarction | Uncontrolled hypertension | Blood pressure determination | Unstable diabetes mellitus | Resting Dyspnea | Oxygen Therapy chronic
Item
4. known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
boolean
C0002962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C1400513 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0005824 (UMLS CUI [7])
C0342302 (UMLS CUI [8])
C0743330 (UMLS CUI [9])
C0184633 (UMLS CUI [10,1])
C0205191 (UMLS CUI [10,2])
Communicable Disease | Communicable Disease Uncontrolled
Item
5. active or uncontrolled infection,
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Dementia | Abnormal mental state | Mental condition Preventing Informed Consent
Item
6. dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of icf,
boolean
C0497327 (UMLS CUI [1])
C0278061 (UMLS CUI [2])
C3840291 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Neoadjuvant Therapy Malignant Neoplasm | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Exception Investigational Therapy
Item
7. concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
boolean
C0600558 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0949266 (UMLS CUI [6,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
8. previous or concomitant malignancy within the past 3 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Comorbidity Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate | Disease Interferes with Patient safety
Item
9. concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
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