ID

17915

Description

Photodynamic Therapy With Talaporfin Sodium (LS11) in Treating Patients With Refractory Colorectal Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00068068

Link

https://clinicaltrials.gov/show/NCT00068068

Keywords

Versions (2)
  1. 10/8/16 10/8/16 -
  2. 10/8/16 10/8/16 -
Uploaded on

October 8, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Liver Metastasis NCT00068068

English

Eligibility Liver Metastasis NCT00068068

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic disease.
Description

Lesion of liver Metastatic Due to colorectal disorder | Metastatic Neoplasm Chemotherapy failed | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0036525
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C2103078
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0242656
biopsy proven evidence of colorectal cancer.
Description

Colorectal Carcinoma Evidence of | Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0005558
patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter.
Description

Lesion Quantity | Lesion size | Lesion Diameter Maximum

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0449453
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0806909
age greater than or equal to 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must be able to sign informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
life expectancy greater than or equal to 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following litx therapy.
Description

Disease Extrahepatic | Secondary malignant neoplasm of liver | systemic therapy Disease Extrahepatic | Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
UMLS CUI [2]
C0494165
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1517058
UMLS CUI [4]
C0949266
off chemotherapy for 4 weeks. must have recovered from the chemotherapy effects.
Description

Chemotherapy ended | Chemotherapy Effects Patients Recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2746065
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C0521108
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must be excluded if any of the following apply:
Description

Patients Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C2828389
patients who are candidates for complete surgical resection.
Description

Indication Complete excision

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0015250
pregnancy or breast-feeding. a negative pregnancy test (urine or serum) is required prior to enrollment.
Description

Pregnancy | Breast Feeding | Urine pregnancy test negative Patient need for | Serum pregnancy test negative Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0430057
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C0430061
UMLS CUI [4,2]
C0686904
known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.
Description

Allergic Reaction Serious Uncontrolled Contrast Media Investigational | anaphylaxis Contrast Media Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [1,4]
C0009924
UMLS CUI [1,5]
C1517586
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0009924
UMLS CUI [2,3]
C1517586
pt or ptt greater than 1.5x control.
Description

Prothrombin time | Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0030605
platelet count less than 100,000.
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
wbc less than 2500/mm.
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
neutrophils less than 2000/mm.
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin less than 9 g/dl.
Description

Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
liver enzymes greater than 3 x uln.
Description

liver enzymes

Data type

boolean

Alias
UMLS CUI [1]
C1287351
total bilirubin greater than 1.5 x uln.
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine greater than 2.5 x uln.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Back to the top of the page

Similar models

Eligibility Liver Metastasis NCT00068068

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lesion of liver Metastatic Due to colorectal disorder | Metastatic Neoplasm Chemotherapy failed | Disease Progression
Item
patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic disease.
boolean
C0577053 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C2103078 (UMLS CUI [1,4])
C2939420 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3])
Colorectal Carcinoma Evidence of | Biopsy
Item
biopsy proven evidence of colorectal cancer.
boolean
C0009402 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
Lesion Quantity | Lesion size | Lesion Diameter Maximum
Item
patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter.
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0449453 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0806909 (UMLS CUI [3,3])
Age
Item
age greater than or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patients must be able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than or equal to 3 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Disease Extrahepatic | Secondary malignant neoplasm of liver | systemic therapy Disease Extrahepatic | Therapies, Investigational
Item
patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following litx therapy.
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0494165 (UMLS CUI [2])
C1515119 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1517058 (UMLS CUI [3,3])
C0949266 (UMLS CUI [4])
Chemotherapy ended | Chemotherapy Effects Patients Recovered
Item
off chemotherapy for 4 weeks. must have recovered from the chemotherapy effects.
boolean
C0392920 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0521108 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Patients Excluded
Item
patients must be excluded if any of the following apply:
boolean
C0030705 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Indication Complete excision
Item
patients who are candidates for complete surgical resection.
boolean
C3146298 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Urine pregnancy test negative Patient need for | Serum pregnancy test negative Patient need for
Item
pregnancy or breast-feeding. a negative pregnancy test (urine or serum) is required prior to enrollment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430057 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0430061 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Allergic Reaction Serious Uncontrolled Contrast Media Investigational | anaphylaxis Contrast Media Investigational
Item
known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.
boolean
C1527304 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0009924 (UMLS CUI [1,4])
C1517586 (UMLS CUI [1,5])
C0002792 (UMLS CUI [2,1])
C0009924 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
Prothrombin time | Partial Thromboplastin Time measurement
Item
pt or ptt greater than 1.5x control.
boolean
C0033707 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count less than 100,000.
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc less than 2500/mm.
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
neutrophils less than 2000/mm.
boolean
C0948762 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin less than 9 g/dl.
boolean
C0019046 (UMLS CUI [1])
liver enzymes
Item
liver enzymes greater than 3 x uln.
boolean
C1287351 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin greater than 1.5 x uln.
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine greater than 2.5 x uln.
boolean
C0201976 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial