ID

12105

Beschrijving

A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program; ODM derived from: https://clinicaltrials.gov/show/NCT02218801

Link

https://clinicaltrials.gov/show/NCT02218801

Trefwoorden

Versies (2)
  1. 23-09-15 23-09-15 - Julian Varghese
  2. 23-09-15 23-09-15 - Julian Varghese
Geüploaded op

23 september 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Liver Metastasis NCT02218801

Engels

Eligibility Liver Metastasis NCT02218801

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
with histologically proven colorectal adenocarcinoma with liver metastasis.
Beschrijving

Adenocarcinoma of large intestine; Secondary malignant neoplasm of liver

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C0494165
with unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (mdt).
Beschrijving

Unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits. Borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the mdt. Initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the mdt to be resectable

Datatype

boolean

Alias
UMLS CUI [1]
C1319315
UMLS CUI [2,1]
C0494165
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C1519810
UMLS CUI [3,3]
C0205189
participants of the mdt must include at least one liver surgeon, one radiologist and one oncologist. they will determine the resectability of the crlm according to local practice.
Beschrijving

Specialist multidisciplinary team

Datatype

boolean

Alias
UMLS CUI [1]
C1319406
With a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) must be planned (if indicated after preoperative systemic treatment) during the mdt.
Beschrijving

surgical procedure;Operation on liver

Datatype

boolean

Alias
UMLS CUI [1]
C0193373
age ≥ 18 years.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
before patient registration, written informed consent must be given according to ich/gcp, and national/local regulations.
Beschrijving

written informed consent;

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any psychological, familial, or sociological condition potentially hampering understanding of the research project.
Beschrijving

psychological disease | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C1658764
UMLS CUI [2]
C0021430
UMLS CUI [3]
C3850138
any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
Beschrijving

Malignant Neoplasms | Carcinoma in situ of uterine cervix | Malignant neoplasm of skin | melanoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851140
UMLS CUI [3]
C0007114
UMLS CUI [4]
C0025202
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Similar models

Eligibility Liver Metastasis NCT02218801

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine; Secondary malignant neoplasm of liver
Item
with histologically proven colorectal adenocarcinoma with liver metastasis.
boolean
C1319315 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
Adenocarcinoma of large intestine | Secondary malignant neoplasm of liver; unresectable | Secondary malignant neoplasm of liver; unresectable; borderline
Item
with unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (mdt).
boolean
C1319315 (UMLS CUI [1])
C0494165 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0494165 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0205189 (UMLS CUI [3,3])
Specialist multidisciplinary team
Item
participants of the mdt must include at least one liver surgeon, one radiologist and one oncologist. they will determine the resectability of the crlm according to local practice.
boolean
C1319406 (UMLS CUI [1])
surgical procedure;Operation on liver
Item
With a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) must be planned (if indicated after preoperative systemic treatment) during the mdt.
boolean
C0193373 (UMLS CUI [1])
age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
written informed consent;
Item
before patient registration, written informed consent must be given according to ich/gcp, and national/local regulations.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
psychological disease | Informed Consent
Item
any psychological, familial, or sociological condition potentially hampering understanding of the research project.
boolean
C1658764 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C3850138 (UMLS CUI [3])
Malignant Neoplasms | Carcinoma in situ of uterine cervix | Malignant neoplasm of skin | melanoma
Item
any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007114 (UMLS CUI [3])
C0025202 (UMLS CUI [4])
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