Hepatocellular CarcinomaNCT01777698
Body Composition Analysis in Patients Undergoing Chemoembolization
An observational study of Hepatocellular Carcinoma, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 21 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2012to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be recruited from the Radiology Department of a tertiary care center.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, 14000
About this study
Official title: Body Composition Analysis by Bioelectrical Impedance Vector Analysis in Patients With Hepatocellular Carcinoma Undergoing Chemoembolization.
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.
Read more
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.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- body composition, hepatocellular carcinoma, chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition
To evaluate any changes in corporal composition in patients undergoing chemoembolization.
Measured: 1 hour before treatment, 2 weeks after treatment, and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionAug 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aldo Torre, M.D, M.Sc., Study chair, Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777698
- Sponsor's protocol ID
- QMECR1
- Status last verified
- Jun 2016
- First submitted
- 21 Jan 2013
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Analysis by Bioelectrical Impedance Vector Analysis in Patients With Hepatocellular Carcinoma Undergoing Chemoembolization.
- ClinicalTrials.gov ID
- NCT01777698
- Acronym / sponsor ID
- QMECR1
- Conditions
- Hepatocellular Carcinoma
- Keywords
- body composition, hepatocellular carcinoma, chemoembolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited from the Radiology Department of a tertiary care center.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in body composition
Time frame: 1 hour before treatment, 2 weeks after treatment, and 1 month after treatment
To evaluate any changes in corporal composition in patients undergoing chemoembolization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo Torre, M.D, M.Sc. study chair
Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body composition (time frame: 1 hour before treatment, 2 weeks after treatment, and 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.