Body Composition Analysis in Patients Undergoing Chemoembolization
This study is currently recruiting participants.
Verified January 2013 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01777698
First received: January 21, 2013
Last updated: January 24, 2013
Last verified: January 2013
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Purpose
Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of patients with hepatocellular carcinoma are associated with cirrhosis.
Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into the hepatic tumor where the principal artery is embolized.
Bioelectrical impedance bases its evaluation in a model where the body is conformed by two different compartments: fat mass and fat free mass.
Bioelectrical impedance is complemented by vectorial analysis, which is independent to the state of hydration and is helpful to monitor any changes in corporal composition. It can be used as a control for the interpretation of the bioelectrical impedance.
| Condition |
|---|
|
Hepatocellular Carcinoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Body Composition Analysis by Bioelectrical Impedance Vector Analysis in Patients With Hepatocellular Carcinoma Undergoing Chemoembolization. |
Resource links provided by NLM:
Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Primary Outcome Measures:
- Changes in body composition [ Time Frame: 1 hour before treatment, 2 weeks after treatment, and 1 month after treatment ] [ Designated as safety issue: No ]To evaluate any changes in corporal composition in patients undergoing chemoembolization.
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The patients will be recruited from the Radiology Department of a tertiary care center.
Criteria
Inclusion Criteria:
- Patients with hepato-renal disease
- Patients with hepatocellular carcinoma that are put down to radiofrequency ablation
- Patients with depression or any psiquiatric disease.
- Patients that don't agree to participate in the project.
Exclusion Criteria:
- Patients with hepatocellular carcinoma that are put down to radiofrequency ablation
- Patients with depression or any psiquiatric disease.
- Patients that don't agree to participate in the project.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777698
Contacts
| Contact: Aldo Torre, M.D., M.Sc. | 54870900 ext 2711 | detoal@yahoo.com |
| Contact: Carmen F Romo-Estrada | 54870900 ext 2711 | krmsy24@gmail.com |
Locations
| Mexico | |
| Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" | Recruiting |
| Mexico city, Mexico, 14000 | |
| Contact: Aldo Torre, M.D, M.Sc. 54870900 ext 2711 detoal@yahoo.com | |
| Principal Investigator: Aldo Torre, M.D., M.Sc. | |
| Sub-Investigator: Carmen F Romo-Estrada | |
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
| Study Chair: | Aldo Torre, M.D, M.Sc. | Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán" |
More Information
No publications provided
| Responsible Party: | ALDO TORRE DELGADILLO, M.D., M.Sc., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| ClinicalTrials.gov Identifier: | NCT01777698 History of Changes |
| Other Study ID Numbers: | QMECR1 |
| Study First Received: | January 21, 2013 |
| Last Updated: | January 24, 2013 |
| Health Authority: | Mexico: Ethics Committee |
Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
|
body composition hepatocellular carcinoma chemoembolization |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 19, 2013