ID

28364

Beschreibung

Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00860860

Link

https://clinicaltrials.gov/show/NCT00860860

Stichworte

Versionen (1)
  1. 07.01.18 07.01.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Januar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00860860

Englisch

Eligibility Colorectal Neoplasms NCT00860860

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with cea expressing advanced colorectal tumors for which no standard treatment is available
Beschreibung

Colorectal Carcinoma Advanced CEA Expression | Standard therapy Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0007082
UMLS CUI [1,4]
C0017262
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0332268
who performance status: 0 or 1
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
having normal hematological function: neutrophils > 1.5 x 109/l; platelet count > 150 x 109/l, without transfusion during the previous month; hemoglobin > 5.6 mmol/l
Beschreibung

Hematologic function | Neutrophil count | Platelet Count measurement | Transfusion Absent | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C1879316
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0518015
total bilirubin < 2 x upper limit of normal (uln)
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
asat, alat < 3 x uln
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine < 2 x uln
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
cockcroft clearance > 50 ml/min
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
negative pregnancy test for women of child¬bearing potential (urine or serum)
Beschreibung

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
age over 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ability to provide written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known metastases to the brain
Beschreibung

brain metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
Beschreibung

Chemotherapy | External Beam Radiation Therapy | Immunotherapy | Allowance External Beam Radiation Therapy Field Limited | Prevention Pathological fracture

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1517033
UMLS CUI [3]
C0021083
UMLS CUI [4,1]
C0556660
UMLS CUI [4,2]
C1517033
UMLS CUI [4,3]
C1882536
UMLS CUI [4,4]
C0439801
UMLS CUI [5,1]
C0199176
UMLS CUI [5,2]
C0016663
prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
Beschreibung

Angiogenesis Inhibitors | bevacizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0596087
UMLS CUI [2]
C0796392
cardiac disease with new york heart association classification of iii or iv
Beschreibung

Heart Disease New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status
Beschreibung

Illness Independent of Colorectal Carcinoma | Communicable Disease | Inflammation | Medical condition Affecting Patient Clinical status | Laboratory test result abnormal Affecting Patient Clinical status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0009402
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0021368
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0030705
UMLS CUI [4,4]
C0449440
UMLS CUI [5,1]
C0438215
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0030705
UMLS CUI [5,4]
C0449440
life expectancy shorter than 6 months.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
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Ähnliche Modelle

Eligibility Colorectal Neoplasms NCT00860860

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Advanced CEA Expression | Standard therapy Lacking
Item
patients with cea expressing advanced colorectal tumors for which no standard treatment is available
boolean
C0009402 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0007082 (UMLS CUI [1,3])
C0017262 (UMLS CUI [1,4])
C2936643 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
WHO performance status scale
Item
who performance status: 0 or 1
boolean
C1298650 (UMLS CUI [1])
Hematologic function | Neutrophil count | Platelet Count measurement | Transfusion Absent | Hemoglobin measurement
Item
having normal hematological function: neutrophils > 1.5 x 109/l; platelet count > 150 x 109/l, without transfusion during the previous month; hemoglobin > 5.6 mmol/l
boolean
C0221130 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1879316 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0518015 (UMLS CUI [5])
Serum total bilirubin measurement
Item
total bilirubin < 2 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
asat, alat < 3 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine < 2 x uln
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
cockcroft clearance > 50 ml/min
boolean
C2711451 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
negative pregnancy test for women of child¬bearing potential (urine or serum)
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Age
Item
age over 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
brain metastases
Item
known metastases to the brain
boolean
C0220650 (UMLS CUI [1])
Chemotherapy | External Beam Radiation Therapy | Immunotherapy | Allowance External Beam Radiation Therapy Field Limited | Prevention Pathological fracture
Item
chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
boolean
C0392920 (UMLS CUI [1])
C1517033 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0556660 (UMLS CUI [4,1])
C1517033 (UMLS CUI [4,2])
C1882536 (UMLS CUI [4,3])
C0439801 (UMLS CUI [4,4])
C0199176 (UMLS CUI [5,1])
C0016663 (UMLS CUI [5,2])
Angiogenesis Inhibitors | bevacizumab
Item
prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
boolean
C0596087 (UMLS CUI [1])
C0796392 (UMLS CUI [2])
Heart Disease New York Heart Association Classification
Item
cardiac disease with new york heart association classification of iii or iv
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Illness Independent of Colorectal Carcinoma | Communicable Disease | Inflammation | Medical condition Affecting Patient Clinical status | Laboratory test result abnormal Affecting Patient Clinical status
Item
any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status
boolean
C0221423 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
C0021368 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
C0449440 (UMLS CUI [4,4])
C0438215 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0030705 (UMLS CUI [5,3])
C0449440 (UMLS CUI [5,4])
Life Expectancy
Item
life expectancy shorter than 6 months.
boolean
C0023671 (UMLS CUI [1])
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