Acquired Immunodeficiency Syndrome VirusNCT02113865
Score System for Prediction Risk and Early Diagnosis of HCC in HIV/HCV Patients
An observational study of Acquired Immunodeficiency Syndrome Virus and Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome Virus, Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted, Hepatocellular Carcinoma
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Feb 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV/HCV coinfected patients from Infectious Diseases Department
Who may be able to join
- Human immunodeficiency virus chronic infection
- Hepatitis C virus chronic infection
- No other liver viral coinfections
Who cannot join
- Alcohol consume
- Immunosuppressor or immunoactive treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obtención de un Panel de puntuación ("Score System") Para la predicción de Riesgo Individualizado y la detección Precoz de Carcinoma Hepatocelular (HCC) en Sujetos Coinfectados VIH/VHC
The aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (HCC).
Read the detailed description
Transversal study design like a "proof of concept".
Primary objective:
The main objective is try to stablish a descriptive panel (first phase of a score system) based in the conjunction or sum of several clinical and laboratory parameters (molecular and genetic factors). The aim is to detect in a fast, early and successful way those patients that presents a high risk to develop an hepatocellular carcinoma (HCC) in the future in a specific population: HIV and HCV coinfected patients. The establishment of this panel will allow clinicians set up a correct treatment decreasing the probability of liver cirrhosis and HCC.
- Conditions
- Acquired Immunodeficiency Syndrome Virus, Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted, Hepatocellular Carcinoma
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Grupo 0 | Null or mild fibrosis | |
| Grupo 1 | Cirrhosis | |
| Grupo 2 | HCC diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sera inflammatory markers
Inflammatory markers will be measure used a Enzyme-linked Immunosorbent Assay
Measured: 1 day (Routine visit to normal following in Infectious Disease Department)
Secondary outcomes (1)
Sera apoptotic markers
Apoptotic markers will be evaluated through a Enzyme-linked Immunosorbent Assay
Measured: 1 day (Routine visit in disease following at Infectious Disease Department)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency Syndrome VirusStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Responsible party
- Sponsor
- Investigators
- Beatriz S Sastre, PhD, Principal investigator, Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113865
- Sponsor's protocol ID
- FMM115392013
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 9 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obtención de un Panel de puntuación ("Score System") Para la predicción de Riesgo Individualizado y la detección Precoz de Carcinoma Hepatocelular (HCC) en Sujetos Coinfectados VIH/VHC
- ClinicalTrials.gov ID
- NCT02113865
- Acronym / sponsor ID
- FMM115392013
- Conditions
- Acquired Immunodeficiency Syndrome Virus, Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Apr 2014 (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.
The aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (HCC).
Detailed description
Transversal study design like a "proof of concept".
Primary objective:
The main objective is try to stablish a descriptive panel (first phase of a score system) based in the conjunction or sum of several clinical and laboratory parameters (molecular and genetic factors). The aim is to detect in a fast, early and successful way those patients that presents a high risk to develop an hepatocellular carcinoma (HCC) in the future in a specific population: HIV and HCV coinfected patients. The establishment of this panel will allow clinicians set up a correct treatment decreasing the probability of liver cirrhosis and HCC.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grupo 0 | – | –Null or mild fibrosis |
| Grupo 1 | – | –Cirrhosis |
| Grupo 2 | – | –HCC diagnosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV/HCV coinfected patients from Infectious Diseases Department
Key inclusion criteria (3 listed)
- Human immunodeficiency virus chronic infection
- Hepatitis C virus chronic infection
- No other liver viral coinfections
Key exclusion criteria (2 listed)
- Alcohol consume
- Immunosuppressor or immunoactive treatment
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
Sera inflammatory markers
Time frame: 1 day (Routine visit to normal following in Infectious Disease Department)
Inflammatory markers will be measure used a Enzyme-linked Immunosorbent Assay
1 secondary outcome
Sera apoptotic markers
Time frame: 1 day (Routine visit in disease following at Infectious Disease Department)
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 9 Mar 2015.
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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.
Beatriz S Sastre, PhD principal investigator
Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
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 Acquired Immunodeficiency Syndrome Virus and Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 3 inclusion and 2 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 9 Mar 2015. 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 Spain. 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?
Sera inflammatory markers (time frame: 1 day (Routine visit to normal following in Infectious Disease Department)). 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 9 Mar 2015.