ID

30252

Beskrivning

Pilot Investigation of Ultrasound Imaging and Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Locally-Advanced Breast Cancer Response to Neoadjuvant Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00437879

Länk

https://clinicaltrials.gov/show/NCT00437879

Nyckelord

Versioner (1)
  1. 2018-05-24 2018-05-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Locally Advanced Breast Cancer NCT00437879

Engelsk

Eligibility Locally Advanced Breast Cancer NCT00437879

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
the following criteria are necessary for study participation:
Beskrivning

Study Subject Participation Status | Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
1. histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
Beskrivning

Locally advanced breast cancer | First line treatment Absent | Chemotherapy Neoadjuvant | Chemoradiotherapy Neoadjuvant

Datatyp

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
UMLS CUI [4,1]
C0436307
UMLS CUI [4,2]
C0600558
2. measurable disease by ultrasound, or mri performed within 28 days prior to treatment
Beskrivning

Measurable Disease Ultrasonography | Measurable Disease MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0041618
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0024485
3. eastern co-operative oncology group (ecog) performance status of 0 or 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. life expectancy of at least 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
5. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:
Beskrivning

Bone Marrow function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
hemoglobin >90 mg/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
leukocytes >3,000/ml
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count >1,500/ml
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets >100,000/ml
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin within normal institutional limits
Beskrivning

Bilirubin total normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0860928
ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine within normal institutional limits or creatinine clearance >60 ml/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
Beskrivning

Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0438244
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0700225
6. patients should have the ability to understand and the willingness to sign a written informed consent document. signed informed consent must be obtained prior to any study specific procedures
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following conditions will exclude women from participation:
Beskrivning

Gender | Exclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0680251
1. chemotherapy, radiotherapy, or major surgery within 4 prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Major surgery | Adverse event Due to Pharmaceutical Preparations | Patient Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0679637
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0013227
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C2004454
UMLS CUI [5,3]
C0332268
2. receiving any other investigational agents
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
3. known brain metastases
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
4. history of allergic reactions attributed to compounds of similar chemical or biologic composition
Beskrivning

Allergic Reaction Compound Chemical Structure Similar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0220807
UMLS CUI [1,4]
C2348205
5. contraindications to radiotherapy such as but not limited to:
Beskrivning

Medical contraindication Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449
previous radiotherapy to an involved area
Beskrivning

Prior radiation therapy Area Involved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005902
UMLS CUI [1,3]
C1314939
active collagen vascular disease
Beskrivning

Collagen-vascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0262428
genetic diseases associated with hyper-radiosensitivity
Beskrivning

Hereditary Diseases Associated with Sensitivity to radiation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019247
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0520903
6. any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy
Beskrivning

Communicable Diseases Serious | Requirement Anti-Bacterial Agents Systemic | Requirement Antifungal Agents Systemic | Requirement Antiviral Agents Systemic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0279516
UMLS CUI [2,3]
C0205373
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0003308
UMLS CUI [3,3]
C0205373
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0003451
UMLS CUI [4,3]
C0205373
7. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
Beskrivning

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
8. psychiatric illness/social situations that would limit compliance with study requirements
Beskrivning

Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
9. history of active ongoing seizure disorder
Beskrivning

Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
10. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Beskrivning

Substance Use Disorders Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Study Subject Participation Status | Social Conditions Interfere with Evaluation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0683954
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1261322
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C0037403
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C2348568
UMLS CUI [8,1]
C0037403
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C1261322
UMLS CUI [8,4]
C0683954
11. any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Beskrivning

Patient's condition unstable | Condition compromises Patient safety | Condition compromises Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0438114
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
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Similar models

Eligibility Locally Advanced Breast Cancer NCT00437879

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Criteria Fulfill
Item
the following criteria are necessary for study participation:
boolean
C2348568 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Locally advanced breast cancer | First line treatment Absent | Chemotherapy Neoadjuvant | Chemoradiotherapy Neoadjuvant
Item
1. histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
boolean
C3495949 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0436307 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
Measurable Disease Ultrasonography | Measurable Disease MRI
Item
2. measurable disease by ultrasound, or mri performed within 28 days prior to treatment
boolean
C1513041 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
ECOG performance status
Item
3. eastern co-operative oncology group (ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
5. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Hemoglobin measurement
Item
hemoglobin >90 mg/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
leukocytes >3,000/ml
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count >1,500/ml
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >100,000/ml
boolean
C0032181 (UMLS CUI [1])
Bilirubin total normal
Item
total bilirubin within normal institutional limits
boolean
C0860928 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised
Item
creatinine within normal institutional limits or creatinine clearance >60 ml/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
boolean
C0438244 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
Informed Consent
Item
6. patients should have the ability to understand and the willingness to sign a written informed consent document. signed informed consent must be obtained prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender | Exclusion Criteria
Item
the following conditions will exclude women from participation:
boolean
C0079399 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure | Major surgery | Adverse event Due to Pharmaceutical Preparations | Patient Recovery Lacking
Item
1. chemotherapy, radiotherapy, or major surgery within 4 prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
C0877248 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Investigational New Drugs
Item
2. receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
3. known brain metastases
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Compound Chemical Structure Similar
Item
4. history of allergic reactions attributed to compounds of similar chemical or biologic composition
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0220807 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Medical contraindication Therapeutic radiology procedure
Item
5. contraindications to radiotherapy such as but not limited to:
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Prior radiation therapy Area Involved
Item
previous radiotherapy to an involved area
boolean
C0279134 (UMLS CUI [1,1])
C0005902 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Collagen-vascular disease
Item
active collagen vascular disease
boolean
C0262428 (UMLS CUI [1])
Hereditary Diseases Associated with Sensitivity to radiation
Item
genetic diseases associated with hyper-radiosensitivity
boolean
C0019247 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0520903 (UMLS CUI [1,3])
Communicable Diseases Serious | Requirement Anti-Bacterial Agents Systemic | Requirement Antifungal Agents Systemic | Requirement Antiviral Agents Systemic
Item
6. any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0279516 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0003308 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0003451 (UMLS CUI [4,2])
C0205373 (UMLS CUI [4,3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia
Item
7. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
8. psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Epilepsy
Item
9. history of active ongoing seizure disorder
boolean
C0014544 (UMLS CUI [1])
Substance Use Disorders Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Study Subject Participation Status | Social Conditions Interfere with Evaluation Research results
Item
10. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0037403 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0037403 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Patient's condition unstable | Condition compromises Patient safety | Condition compromises Protocol Compliance
Item
11. any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
boolean
C0438114 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
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