ID

16815

Beskrivning

Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00199862

Länk

https://clinicaltrials.gov/show/NCT00199862

Nyckelord

Versioner (1)
  1. 2016-08-08 2016-08-08 -
Uppladdad den

8 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00199862

Engelsk

Eligibility Colorectal Neoplasms NCT00199862

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary or metastatic colorectal carcinoma, histologically confirmed at memorial sloan-kettering cancer center (mskcc).
Beskrivning

Colorectal Carcinoma Primary | Colorectal cancer metastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0948380
patients must be candidates for clinically indicated surgery/biopsy for primary/metastatic colorectal cancer
Beskrivning

Indication Operative Surgical Procedures Colorectal Carcinoma Primary | Indication Biopsy Colorectal Carcinoma Primary | Indication Operative Surgical Procedures Colorectal cancer metastatic | Indication Biopsy Colorectal cancer metastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0009402
UMLS CUI [1,4]
C0205225
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0009402
UMLS CUI [2,4]
C0205225
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0948380
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0005558
UMLS CUI [4,3]
C0948380
expected survival of at least 3 months.
Beskrivning

Survival time Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2919552
UMLS CUI [1,2]
C1517001
karnofsky performance status ≥ 70 (ecog 0 or 1).
Beskrivning

Karnofsky Performance Status | ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
the following laboratory results within the last 2 weeks prior to study day 1:
Beskrivning

Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
absolute neutrophil count (anc) ≥ 1.5 x 109/l platelet count ≥ 75 x 109/l serum bilirubin
Beskrivning

Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1278039
≤ 2.5 mg/dl serum creatinine ≤ 2.0 mg/dl white blood count (wbc) ≥ 3,000/mm3 age ≥ 18 years. children of all ages are not included as colon cancer is extremely rare in children.
Beskrivning

Creatinine measurement, serum | White Blood Cell Count procedure | Age | Colon Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0699790
women of childbearing potential with confirmed negative pregnancy test on the day of administration of study agent.
Beskrivning

Childbearing Potential Pregnancy test negative | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2]
C0013230
before any trial-specific procedures or treatment can be performed, the patient or patient's legally authorized guardian or representative must give witnessed written informed consent for participation in the tria
Beskrivning

Informed Consent | Informed Consent Legal Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant cardiac disease (new york heart association class iii/iv).
Beskrivning

Heart Disease Clinical Significance | New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C1275491
active cns tumor involvement. previous treatment with a33 or its fragment and/or a positive test for hua33 haha.
Beskrivning

Central Nervous System Neoplasm Involvement | A33 monoclonal antibody | A33 monoclonal antibody Fragment of | Test Positive A33 monoclonal antibody HAHA

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085136
UMLS CUI [1,2]
C1314939
UMLS CUI [2]
C0392959
UMLS CUI [3,1]
C0392959
UMLS CUI [3,2]
C0332255
UMLS CUI [4,1]
C0392366
UMLS CUI [4,2]
C1446409
UMLS CUI [4,3]
C0392959
UMLS CUI [4,4]
C3641682
lack of availability for immunological and clinical follow-up assessments.
Beskrivning

follow-up immunologic | follow-up Clinical | Patient Availability Lack

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0205470
UMLS CUI [2,1]
C1522577
UMLS CUI [2,2]
C0205210
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0470187
UMLS CUI [3,3]
C0332268
participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
women who are pregnant or breast-feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Colorectal Neoplasms NCT00199862

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Primary | Colorectal cancer metastatic
Item
primary or metastatic colorectal carcinoma, histologically confirmed at memorial sloan-kettering cancer center (mskcc).
boolean
C0009402 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0948380 (UMLS CUI [2])
Indication Operative Surgical Procedures Colorectal Carcinoma Primary | Indication Biopsy Colorectal Carcinoma Primary | Indication Operative Surgical Procedures Colorectal cancer metastatic | Indication Biopsy Colorectal cancer metastatic
Item
patients must be candidates for clinically indicated surgery/biopsy for primary/metastatic colorectal cancer
boolean
C3146298 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C3146298 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0009402 (UMLS CUI [2,3])
C0205225 (UMLS CUI [2,4])
C3146298 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0948380 (UMLS CUI [3,3])
C3146298 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C0948380 (UMLS CUI [4,3])
Survival time Expected
Item
expected survival of at least 3 months.
boolean
C2919552 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Karnofsky Performance Status | ECOG performance status
Item
karnofsky performance status ≥ 70 (ecog 0 or 1).
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Laboratory Results
Item
the following laboratory results within the last 2 weeks prior to study day 1:
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement
Item
absolute neutrophil count (anc) ≥ 1.5 x 109/l platelet count ≥ 75 x 109/l serum bilirubin
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Creatinine measurement, serum | White Blood Cell Count procedure | Age | Colon Carcinoma
Item
≤ 2.5 mg/dl serum creatinine ≤ 2.0 mg/dl white blood count (wbc) ≥ 3,000/mm3 age ≥ 18 years. children of all ages are not included as colon cancer is extremely rare in children.
boolean
C0201976 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0699790 (UMLS CUI [4])
Childbearing Potential Pregnancy test negative | Investigational New Drugs
Item
women of childbearing potential with confirmed negative pregnancy test on the day of administration of study agent.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Informed Consent | Informed Consent Legal Guardian
Item
before any trial-specific procedures or treatment can be performed, the patient or patient's legally authorized guardian or representative must give witnessed written informed consent for participation in the tria
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Heart Disease Clinical Significance | New York Heart Association Classification
Item
clinically significant cardiac disease (new york heart association class iii/iv).
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
Central Nervous System Neoplasm Involvement | A33 monoclonal antibody | A33 monoclonal antibody Fragment of | Test Positive A33 monoclonal antibody HAHA
Item
active cns tumor involvement. previous treatment with a33 or its fragment and/or a positive test for hua33 haha.
boolean
C0085136 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0392959 (UMLS CUI [2])
C0392959 (UMLS CUI [3,1])
C0332255 (UMLS CUI [3,2])
C0392366 (UMLS CUI [4,1])
C1446409 (UMLS CUI [4,2])
C0392959 (UMLS CUI [4,3])
C3641682 (UMLS CUI [4,4])
follow-up immunologic | follow-up Clinical | Patient Availability Lack
Item
lack of availability for immunological and clinical follow-up assessments.
boolean
C1522577 (UMLS CUI [1,1])
C0205470 (UMLS CUI [1,2])
C1522577 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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