ID

43822

Beschreibung

HR Versus RFA for HCC in Patients With PHT; ODM derived from: https://clinicaltrials.gov/show/NCT02192671

Link

https://clinicaltrials.gov/show/NCT02192671

Stichworte

Versionen (2)
  1. 04.05.16 04.05.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT02192671

Englisch

Eligibility Carcinoma, Hepatocellular NCT02192671

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
in the hr group, clinical diagnosis of hcc was confirmed by histopathological examination of surgical samples in all patients; in the rfa group, hcc diagnosis was confirmed by two types of clinical imaging (ultrasonography, computed tomography, or magnetic resonance imaging), togetherwith a serum level of α-fetoprotein higher than 400 ng/ml. if diagnosis based on imaging andα-fetoprotein level was uncertain, needle biopsy was performed.
Beschreibung

Liver carcinoma | Resection of hepatic ducts Group | Histopathology | Surgical excision sample | Radiofrequency ablation Group | Ultrasonography | X-Ray Computed Tomography | Magnetic Resonance Imaging | serum alpha-fetoprotein (AFP) measurement | Needle biopsy procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0193481
UMLS CUI [2,2]
C0441833
UMLS CUI [3]
C0677043
UMLS CUI [4]
C1298665
UMLS CUI [5,1]
C0850292
UMLS CUI [5,2]
C0441833
UMLS CUI [6]
C0041618
UMLS CUI [7]
C0040405
UMLS CUI [8]
C0024485
UMLS CUI [9]
C0546833
UMLS CUI [10]
C0005560
tumor stage fitted into milan criteria
Beschreibung

Tumor stage

Datentyp

boolean

Alias
UMLS CUI [1]
C1300072
patients with clinically relevant portal hypertension, which is defined as the presence of esophageal varices and/or a platelet count of less than 100 000 per μl in association with splenomegaly.
Beschreibung

Hypertension, Portal | Esophageal Varices | Finding of platelet count | Splenomegaly

Datentyp

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0014867
UMLS CUI [3]
C1287267
UMLS CUI [4]
C0038002
patients have child-pugh a or b liver function
Beschreibung

Liver function Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C4050412
no previous neoadjuvant treatment
Beschreibung

Neoadjuvant Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0600558
no evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
Beschreibung

lymph nodes | Neoplasm Metastasis | TNM clinical staging - distant metastases - M | Diagnostic Imaging Preoperative | Finding perioperative

Datentyp

boolean

Alias
UMLS CUI [1]
C0024204
UMLS CUI [2]
C0027627
UMLS CUI [3]
C3258247
UMLS CUI [4,1]
C0011923
UMLS CUI [4,2]
C0445204
UMLS CUI [5,1]
C0243095
UMLS CUI [5,2]
C1518988
no malignancy other than hcc for 5 years prior to the initial hcc treatment
Beschreibung

Malignant Neoplasms | Liver carcinoma | Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C2239176
UMLS CUI [3]
C0087111
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiac disease
Beschreibung

Heart Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
known history of human immunodeficiency virus (hiv) infection
Beschreibung

HIV Infections

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
known central nervous system tumors including metastatic brain disease
Beschreibung

Central Nervous System Neoplasms | Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0085136
UMLS CUI [2]
C0220650
history of organ allograft
Beschreibung

Organ Homologous Transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Beschreibung

Substance Use Disorders | Disease | Social Conditions | Study Subject Participation Status Limited | Interferes with Evaluation research results

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0012634
UMLS CUI [3]
C0037403
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C0439801
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C0220825
UMLS CUI [5,3]
C0683954
any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Beschreibung

Patient's condition unstable | Patient condition Affecting patient safety | Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1]
C0438114
UMLS CUI [2,1]
C0683521
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
pregnant or breast-feeding patients.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Carcinoma, Hepatocellular NCT02192671

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-75 years
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma | Resection of hepatic ducts Group | Histopathology | Surgical excision sample | Radiofrequency ablation Group | Ultrasonography | X-Ray Computed Tomography | Magnetic Resonance Imaging | serum alpha-fetoprotein (AFP) measurement | Needle biopsy procedure
Item
in the hr group, clinical diagnosis of hcc was confirmed by histopathological examination of surgical samples in all patients; in the rfa group, hcc diagnosis was confirmed by two types of clinical imaging (ultrasonography, computed tomography, or magnetic resonance imaging), togetherwith a serum level of α-fetoprotein higher than 400 ng/ml. if diagnosis based on imaging andα-fetoprotein level was uncertain, needle biopsy was performed.
boolean
C2239176 (UMLS CUI [1])
C0193481 (UMLS CUI [2,1])
C0441833 (UMLS CUI [2,2])
C0677043 (UMLS CUI [3])
C1298665 (UMLS CUI [4])
C0850292 (UMLS CUI [5,1])
C0441833 (UMLS CUI [5,2])
C0041618 (UMLS CUI [6])
C0040405 (UMLS CUI [7])
C0024485 (UMLS CUI [8])
C0546833 (UMLS CUI [9])
C0005560 (UMLS CUI [10])
Tumor stage
Item
tumor stage fitted into milan criteria
boolean
C1300072 (UMLS CUI [1])
Hypertension, Portal | Esophageal Varices | Finding of platelet count | Splenomegaly
Item
patients with clinically relevant portal hypertension, which is defined as the presence of esophageal varices and/or a platelet count of less than 100 000 per μl in association with splenomegaly.
boolean
C0020541 (UMLS CUI [1])
C0014867 (UMLS CUI [2])
C1287267 (UMLS CUI [3])
C0038002 (UMLS CUI [4])
Liver function Child-Pugh Classification
Item
patients have child-pugh a or b liver function
boolean
C0232741 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Neoadjuvant Therapy
Item
no previous neoadjuvant treatment
boolean
C0600558 (UMLS CUI [1])
lymph nodes | Neoplasm Metastasis | TNM clinical staging - distant metastases - M | Diagnostic Imaging Preoperative | Finding perioperative
Item
no evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
boolean
C0024204 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C3258247 (UMLS CUI [3])
C0011923 (UMLS CUI [4,1])
C0445204 (UMLS CUI [4,2])
C0243095 (UMLS CUI [5,1])
C1518988 (UMLS CUI [5,2])
Malignant Neoplasms | Liver carcinoma | Therapeutic procedure
Item
no malignancy other than hcc for 5 years prior to the initial hcc treatment
boolean
C0006826 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Heart Diseases
Item
history of cardiac disease
boolean
C0018799 (UMLS CUI [1])
HIV Infections
Item
known history of human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Central Nervous System Neoplasms | Metastatic malignant neoplasm to brain
Item
known central nervous system tumors including metastatic brain disease
boolean
C0085136 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Organ Homologous Transplantation
Item
history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Substance Use Disorders | Disease | Social Conditions | Study Subject Participation Status Limited | Interferes with Evaluation research results
Item
substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0038586 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
C0037403 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0521102 (UMLS CUI [5,1])
C0220825 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])
Patient's condition unstable | Patient condition Affecting patient safety | Compliance behavior Limited
Item
any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
boolean
C0438114 (UMLS CUI [1])
C0683521 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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