ID

19627

Beschreibung

Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00490503

Link

https://clinicaltrials.gov/show/NCT00490503

Stichworte

Versionen (1)
  1. 17.01.17 17.01.17 -
Hochgeladen am

17. Januar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00490503

Englisch

Eligibility Breast Cancer NCT00490503

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with newly diagnosed stage ii a-b or iii a-c breast cancers who are scheduled to start systemic chemotherapy.
Beschreibung

Breast Carcinoma TNM clinical staging | Systemic Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C1883256
2. patients must have a histological diagnosis of invasive breast cancer.
Beschreibung

Invasive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
3. patients whose extent of disease is determined by physical examination and conventional imaging (mammography and sonography).
Beschreibung

Extent of disease Physical Examination | Imaging conventional | Mammography | Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449279
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C0079595
UMLS CUI [2,2]
C0439858
UMLS CUI [3]
C0024671
UMLS CUI [4]
C0041618
4. patients should have not received any previous chemotherapy for their newly diagnosed stage ii a-b or iii a-c breast cancer.
Beschreibung

Chemotherapy Breast Carcinoma TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C3258246
5. patients must be age 18 or older.
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
7. patients with history of prior malignancies must be disease-free for at least 5 years prior of study entry.
Beschreibung

Malignant Neoplasms Free of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332296
8. normal hematological function: wbc > 3000/ul, absolute neutrophil count > 1500/ul, platelets > 100,000/ul, and hgb > 10 gms (transfusion to achieve hgb > 10 gms is acceptable).
Beschreibung

Hematologic function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Transfusion Acceptable

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
UMLS CUI [6,1]
C0005841
UMLS CUI [6,2]
C1879533
9. serum total bilirubin < 1.5 mg/dl and sgpt < 1.5 x normal.
Beschreibung

Serum total bilirubin measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
10. patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. the only acceptable consent form is the one attached at the end of this protocol.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who received previous chemotherapy for the newly diagnosed breast cancer.
Beschreibung

Chemotherapy Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
2. patients with no evidence of primary breast lesion (e.g., t0, tx).
Beschreibung

Lesion of breast Primary Evidence | Lesion of breast TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0567489
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C3887511
UMLS CUI [2,1]
C0567489
UMLS CUI [2,2]
C3258246
3. patients who are unwilling to come back for regular assessments of response.
Beschreibung

Disease Response Assessment Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0558080
4. patients with claustrophobia or obesity (exceeding the equipment weight limits).
Beschreibung

Claustrophobia | Obesity | Equipment Weight Limit Not to Exceed

Datentyp

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2]
C0028754
UMLS CUI [3,1]
C0014672
UMLS CUI [3,2]
C0043100
UMLS CUI [3,3]
C2349209
UMLS CUI [3,4]
C1882121
5. pregnant women, lactating women or sexually active women of childbearing potential who are not practicing adequate contraception.
Beschreibung

Pregnancy | Breast Feeding | Gender Sexually active | Childbearing Potential Contraceptive methods Inadequate

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0205412
6. patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmias.
Beschreibung

Myocardial Infarction | Angina, Unstable | Congestive heart failure Uncontrolled | Cardiac Arrhythmia Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
7. patients with pacemakers or other metallic inserts that are not compatible with 3-t mr scanners.
Beschreibung

Artificial cardiac pacemaker | Implants Metallic | Medical Device Incompatibility Problem 3 Tesla Magnetic Resonance Imaging Scanner

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C2986473
UMLS CUI [3,1]
C1881693
UMLS CUI [3,2]
C2985394
UMLS CUI [3,3]
C0183115
8. patients with bilateral breast disease, and recurrent newly diagnosed breast cancer.
Beschreibung

Breast Disease Bilateral | Breast cancer recurrent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006145
UMLS CUI [1,2]
C0238767
UMLS CUI [2]
C0278493
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Ähnliche Modelle

Eligibility Breast Cancer NCT00490503

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM clinical staging | Systemic Chemotherapy
Item
1. patients with newly diagnosed stage ii a-b or iii a-c breast cancers who are scheduled to start systemic chemotherapy.
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1883256 (UMLS CUI [2])
Invasive carcinoma of breast
Item
2. patients must have a histological diagnosis of invasive breast cancer.
boolean
C0853879 (UMLS CUI [1])
Extent of disease Physical Examination | Imaging conventional | Mammography | Ultrasonography
Item
3. patients whose extent of disease is determined by physical examination and conventional imaging (mammography and sonography).
boolean
C0449279 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0079595 (UMLS CUI [2,1])
C0439858 (UMLS CUI [2,2])
C0024671 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
Chemotherapy Breast Carcinoma TNM clinical staging
Item
4. patients should have not received any previous chemotherapy for their newly diagnosed stage ii a-b or iii a-c breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Age
Item
5. patients must be age 18 or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
6. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasms Free of
Item
7. patients with history of prior malignancies must be disease-free for at least 5 years prior of study entry.
boolean
C0006826 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Hematologic function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Transfusion Acceptable
Item
8. normal hematological function: wbc > 3000/ul, absolute neutrophil count > 1500/ul, platelets > 100,000/ul, and hgb > 10 gms (transfusion to achieve hgb > 10 gms is acceptable).
boolean
C0221130 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0005841 (UMLS CUI [6,1])
C1879533 (UMLS CUI [6,2])
Serum total bilirubin measurement | Alanine aminotransferase measurement
Item
9. serum total bilirubin < 1.5 mg/dl and sgpt < 1.5 x normal.
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Informed Consent | Protocol Compliance
Item
10. patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. the only acceptable consent form is the one attached at the end of this protocol.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Breast Carcinoma
Item
1. patients who received previous chemotherapy for the newly diagnosed breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Lesion of breast Primary Evidence | Lesion of breast TNM clinical staging
Item
2. patients with no evidence of primary breast lesion (e.g., t0, tx).
boolean
C0567489 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,3])
C0567489 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Disease Response Assessment Unwilling
Item
3. patients who are unwilling to come back for regular assessments of response.
boolean
C1704632 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Claustrophobia | Obesity | Equipment Weight Limit Not to Exceed
Item
4. patients with claustrophobia or obesity (exceeding the equipment weight limits).
boolean
C0008909 (UMLS CUI [1])
C0028754 (UMLS CUI [2])
C0014672 (UMLS CUI [3,1])
C0043100 (UMLS CUI [3,2])
C2349209 (UMLS CUI [3,3])
C1882121 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Gender Sexually active | Childbearing Potential Contraceptive methods Inadequate
Item
5. pregnant women, lactating women or sexually active women of childbearing potential who are not practicing adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0205412 (UMLS CUI [4,3])
Myocardial Infarction | Angina, Unstable | Congestive heart failure Uncontrolled | Cardiac Arrhythmia Uncontrolled
Item
6. patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmias.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Artificial cardiac pacemaker | Implants Metallic | Medical Device Incompatibility Problem 3 Tesla Magnetic Resonance Imaging Scanner
Item
7. patients with pacemakers or other metallic inserts that are not compatible with 3-t mr scanners.
boolean
C0030163 (UMLS CUI [1])
C0021102 (UMLS CUI [2,1])
C2986473 (UMLS CUI [2,2])
C1881693 (UMLS CUI [3,1])
C2985394 (UMLS CUI [3,2])
C0183115 (UMLS CUI [3,3])
Breast Disease Bilateral | Breast cancer recurrent
Item
8. patients with bilateral breast disease, and recurrent newly diagnosed breast cancer.
boolean
C0006145 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2])
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