ID

37893

Beschreibung

The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01159405

Link

https://clinicaltrials.gov/show/NCT01159405

Stichworte

Versionen (1)
  1. 28.08.19 28.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. August 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01159405

Englisch

Eligibility Breast Cancer NCT01159405

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with newly diagnosed stage i-iv breast cancer (tumor size
Beschreibung

Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
2cm in imaging examinations) who are scheduled to start systemic therapy.
Beschreibung

Tumor size Diagnostic Imaging | Systemic therapy Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0205539
patients must have histological diagnosis of invasive breast cancer.
Beschreibung

Invasive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
extent of disease will be determined by physical examination and conventional radiological studies.
Beschreibung

Extent of disease Physical Examination | Extent of disease Diagnostic radiologic examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449279
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C0449279
UMLS CUI [2,2]
C0043299
must be age 18 or older.
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Malignant Neoplasms Previous | Disease Free Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0449238
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
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
adequate kidney function (creatinine < 1.5 mg/dl).
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Prior Chemotherapy Breast Carcinoma Newly Diagnosed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C1518321
no evidence of primary breast lesion (e.g. t0, tx).
Beschreibung

Absence Lesion of breast Primary TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0567489
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C0474926
pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
Beschreibung

Pregnancy | Childbearing Potential Sexually active Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C0332197
patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
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
patients with history of hypersensitivity/allergy to chitosan/chitin related shellfish foods.
Beschreibung

Hypersensitivity Shellfish Chitosan Related | Hypersensitivity Shellfish Chitin Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0036950
UMLS CUI [1,3]
C0162969
UMLS CUI [1,4]
C0439849
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0036950
UMLS CUI [2,3]
C0008141
UMLS CUI [2,4]
C0439849
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Ähnliche Modelle

Eligibility Breast Cancer NCT01159405

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging
Item
patients with newly diagnosed stage i-iv breast cancer (tumor size
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Tumor size Diagnostic Imaging | Systemic therapy Scheduled
Item
2cm in imaging examinations) who are scheduled to start systemic therapy.
boolean
C0475440 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Invasive carcinoma of breast
Item
patients must have histological diagnosis of invasive breast cancer.
boolean
C0853879 (UMLS CUI [1])
Extent of disease Physical Examination | Extent of disease Diagnostic radiologic examination
Item
extent of disease will be determined by physical examination and conventional radiological studies.
boolean
C0449279 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0449279 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
Age
Item
must be age 18 or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasms Previous | Disease Free Duration
Item
patients with history of prior malignancies must be disease-free for at least 5 years of study entry.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Hematologic function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Transfusion Acceptable
Item
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
serum total bilirubin < 1.5 mg/dl and sgpt < 1.5 x normal.
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
adequate kidney function (creatinine < 1.5 mg/dl).
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Breast Carcinoma Newly Diagnosed
Item
patients who received previous chemotherapy for the newly diagnosed breast cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1518321 (UMLS CUI [1,3])
Absence Lesion of breast Primary TNM Breast tumor staging
Item
no evidence of primary breast lesion (e.g. t0, tx).
boolean
C0332197 (UMLS CUI [1,1])
C0567489 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
Pregnancy | Childbearing Potential Sexually active Contraceptive methods Absent
Item
pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
Myocardial Infarction | Angina, Unstable | Congestive heart failure Uncontrolled | Cardiac Arrhythmia Uncontrolled
Item
patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
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])
Hypersensitivity Shellfish Chitosan Related | Hypersensitivity Shellfish Chitin Related
Item
patients with history of hypersensitivity/allergy to chitosan/chitin related shellfish foods.
boolean
C0020517 (UMLS CUI [1,1])
C0036950 (UMLS CUI [1,2])
C0162969 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0036950 (UMLS CUI [2,2])
C0008141 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
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