ID

13640

Beskrivning

Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities; ODM derived from: https://clinicaltrials.gov/show/NCT00001568

Länk

https://clinicaltrials.gov/show/NCT00001568

Nyckelord

  1. 2016-02-22 2016-02-22 -
Uppladdad den

22 februari 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Colorectal Neoplasm NCT00001568

Eligibility Colorectal Neoplasm NCT00001568

Criteria
Beskrivning

Criteria

rising serum cea levels greater than 6 on two successive tests.
Beskrivning

cea levels

Datatyp

boolean

Alias
UMLS CUI [1]
C0201933
resectable residual or recurrent disease. patients in the occult arm (arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. in addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; ct scan of chest/ abdomen/ pelvis with contrast, mri scan, and chest x-ray. patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified.
Beskrivning

Surgery, residual or recurrent disease, criteria for study groups

Datatyp

boolean

Alias
UMLS CUI [1]
C0038894
UMLS CUI [2]
C0543478
UMLS CUI [3]
C0277556
UMLS CUI [4]
C0027627
patients must have an ecog performance status of 0-1.
Beskrivning

ecog performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
patients must be willing to return to nih for follow-up.
Beskrivning

return to nih for follow-up

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
patients must be able to provide informed consent as demonstrated by the signed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients must be 2 or more months from abdominal or thoracic surgery.
Beskrivning

surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0038894
no patients with medical contraindication to abdominal exploration.
Beskrivning

abdominal exploration

Datatyp

boolean

Alias
UMLS CUI [1]
C0085704
no patients with recurrent disease detected by conventional imaging studies as outlined above. metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. patients must weigh less than 136 kgs. which is the weight limit for the scanner tables.
Beskrivning

recurrent disease, metastatic disease outside of the abdominal cavity, body weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0027627
UMLS CUI [3]
C0005910
no patients with previous injection of murine monoclonal antibodies: human anti-mouse assay (hama) will be performed in patients with prior history of receiving murine monoclonal antibodies.
Beskrivning

prior murine monoclonal antibodies, hama test will be performed

Datatyp

boolean

Alias
UMLS CUI [1]
C2916903
UMLS CUI [2]
C1868744
no patients that are pregnant or breast feeding.
Beskrivning

pregnant or breast feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
patients who are hiv + will be excluded.
Beskrivning

hiv

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682

Similar models

Eligibility Colorectal Neoplasm NCT00001568

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
cea levels
Item
rising serum cea levels greater than 6 on two successive tests.
boolean
C0201933 (UMLS CUI [1])
Surgery, residual or recurrent disease, criteria for study groups
Item
resectable residual or recurrent disease. patients in the occult arm (arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. in addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; ct scan of chest/ abdomen/ pelvis with contrast, mri scan, and chest x-ray. patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified.
boolean
C0038894 (UMLS CUI [1])
C0543478 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
ecog performance status
Item
patients must have an ecog performance status of 0-1.
boolean
C1520224 (UMLS CUI [1])
return to nih for follow-up
Item
patients must be willing to return to nih for follow-up.
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
patients must be able to provide informed consent as demonstrated by the signed consent.
boolean
C0021430 (UMLS CUI [1])
surgery
Item
patients must be 2 or more months from abdominal or thoracic surgery.
boolean
C0038894 (UMLS CUI [1])
abdominal exploration
Item
no patients with medical contraindication to abdominal exploration.
boolean
C0085704 (UMLS CUI [1])
recurrent disease, metastatic disease outside of the abdominal cavity, body weight
Item
no patients with recurrent disease detected by conventional imaging studies as outlined above. metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. patients must weigh less than 136 kgs. which is the weight limit for the scanner tables.
boolean
C0277556 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0005910 (UMLS CUI [3])
prior murine monoclonal antibodies, hama test will be performed
Item
no patients with previous injection of murine monoclonal antibodies: human anti-mouse assay (hama) will be performed in patients with prior history of receiving murine monoclonal antibodies.
boolean
C2916903 (UMLS CUI [1])
C1868744 (UMLS CUI [2])
pregnant or breast feeding
Item
no patients that are pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
hiv
Item
patients who are hiv + will be excluded.
boolean
C0019682 (UMLS CUI [1])

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