Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01744639
Other study ID # GAS 720-12/13-1
Secondary ID
Status Withdrawn
Phase N/A
First received December 5, 2012
Last updated June 7, 2016
Start date December 2012
Est. completion date May 2016

Study information

Verified date June 2016
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact n/a
Is FDA regulated No
Health authority Mexico: Secretaria de Salud
Study type Interventional

Clinical Trial Summary

Number of shows: 20 patients Track: A month with three visiting Intervention: Nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score and Critical Flicker Frequency.


Description:

There will be a prospective, longitudinal, comparative. It included 20 patients diagnosed with hepatocellular carcinoma. As there are a finite number of active patients at the institute, and no studies with sample size well established, has seen a sample size of 20 patients.

The duration of individual monitoring shall be one month to three visits (baseline, week 2 and week 4 after receiving the first radiofrequency ablation). Each visit will be a nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF).

Anthropometric measures to be taken are weight, height and arm circumference average.

Bioelectrical impedance will be using a single frequency impedance meter (425 to -50 KHz, Range 0 to 10,000) Bioelectrical Body Composition Analyzer Quantium II RJL Systems. The team measured the subjects' impedance, resistance, reactance and phase angle by Lean Body program provided by the manufacturer.

Hepatic encephalopathy be evaluated by testing PHES and was measured CFF, also also be measured ammonium, tumor necrosis factor, IL-1, IL-6, IL-10, renin angiotensin aldosterone.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients with a diagnosis of hepatocellular carcinoma, treatment-naive and who are referred to the radiology department for radioablation as first therapy.

- Outpatients.

- Willingness to participate in the project.

Exclusion Criteria:

- Patients with hepato-renal diseases.

- Patients diagnosed with hepatocellular carcinoma undergoing chemoembolization treatment, or who have received more than one session radioablation.

- Patients with depression or psychiatric illnesses

- Patients who do not agree to participate in the project.

Exclusion Criteria:

- incomplete Applied Tests

- disagreement of the person to perform any of the tests

- monitoring Breach

- Hospitalization or death after the first session radioablation.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Behavioral:
HCC under treatment with radioablation
The evaluation will take place over a period of 30 days.

Locations

Country Name City State
Mexico Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City D.f.

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nutritional Status Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculated mid-arm muscle circumference, fat mass, fat free mass total, intracellular and extracellular body water obtained by bioelectrical impedance analysis and individual vectors obtained by bioelectrical impedance vector analysis. Participants will be evaluated for a month No
Secondary Minimal hepatic encephalopathy Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF) Participants will be assessed for one month No
See also
  Status Clinical Trial Phase
Terminated NCT01020812 - Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT04443322 - Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 ) N/A
Completed NCT02305459 - CIRSE Registry for SIR-Spheres Therapy
Terminated NCT00791544 - Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma Phase 1/Phase 2
Active, not recruiting NCT04682847 - Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers
Completed NCT02424955 - Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation N/A
Completed NCT03775863 - AFP Model and Liver Transplantation.
Not yet recruiting NCT04825470 - Liver Transplantation for Unresectable GIST Liver Metastases N/A
Recruiting NCT06144385 - A Phase 1, Single-arm, Open-label, Dose-escalation Study of JWATM204 as T Cell-targeted Immunotherapy in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma Phase 1
Completed NCT01717729 - Hepatocellular Carcinoma Treated With Iodine-125 Implantation Phase 3
Completed NCT03178409 - Combined HCC-MFCCC N/A
Suspended NCT04955808 - Biospecimen Collection in Identifying Genetic Changes in Patients With Breast, Prostate, Colorectal, Liver, or Kidney Cancer or Multiple Myeloma Undergoing Surgery
Recruiting NCT01380392 - The Illness of Uncertainty, Personality and Coping Strategies in Patients With Hepatocellular Carcinoma N/A
Completed NCT01482442 - SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma Phase 3
Active, not recruiting NCT01272557 - Sorafenib Plus Doxorubicin Versus Sorafenib Alone for the Treatment of Advanced Hepatocellular Carcinoma: a Randomized Phase II Trial Phase 2
Completed NCT00328770 - De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma Phase 2/Phase 3
Completed NCT05681234 - Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma N/A
Terminated NCT00767234 - Permission to Collect Blood Over Time for Research N/A
Active, not recruiting NCT02465060 - Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Phase 2
Recruiting NCT04288323 - Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients With Cirrhosis Phase 4