Hepatocellular CarcinomaHSL2012-06NCT01690715
Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery
An observational study of Hepatocellular Carcinoma and Portal Vein Thrombosis, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
A retrospective study based on analysis of medical records of patients with hepatocellular carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with diagnosis confirmed by imaging or histological specimen underwent surgical resection with curative intent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma, Portal Vein Thrombosis, Hepatic Portal Vein Tumor Invasion
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to 30 Aug 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection with curative intent with the presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels.
Who may be able to join
- hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection, with or without hepatic cirrhosis association;
- presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels;
Who cannot join
- Patients undergoing prior systemic treatment;
- Patients presenting incomplete data that do not allow their classification according to the stratification models;
- Patients whose information of progression or death can not be recovered;
Trial locations and contacts
1 site in 1 country.
About this study
A retrospective study based on analysis of medical records of patients with hepatocellular carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with diagnosis confirmed by imaging or histological specimen underwent surgical resection with curative intent. The study aims to determine the prognostic value of vascular complications related to cancer and to evaluate the survival rate of these patients, comparing the data with those reported in the literature.
- Keywords
- Hepatocellular Carcinoma, Thrombosis, Portal Vein Invasion
- Medical subject headings
- Carcinoma, Hepatocellular, Thrombosis
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 |
|---|---|---|
| Hepatocellular carcinoma underwent surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis (disease graduation)
The carcinoma prognosis in the presence of vascular complications related to cancer, characterized by invasion or portal vein thrombosis.
Measured: 1 to 3 years
Secondary outcomes (2)
Survival rate in years
Determination of the survival rate within 1 to 3 years for those submitted to curative hepatectomy.
Measured: 1 to 3 years
Relation established between survival and degree of underlying liver dysfunction
Investigate a possible relationship between survival and degree of underlying liver dysfunction in patients with thrombosis or portal vein invasion in patients undergoing curative hepatectomy.
Measured: 1 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startJul 2012
- Primary completion1 Aug 2012
- Study completion30 Aug 2012
Why it stopped: There was recruted subject
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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Perego Costa, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690715
- Sponsor's protocol ID
- HSL 2012/06
- Acronym
- HSL2012-06
- Status last verified
- Nov 2023
- First submitted
- 12 Sep 2012
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery
- ClinicalTrials.gov ID
- NCT01690715
- Acronym / sponsor ID
- HSL2012-06 / HSL 2012/06
- Keywords
- Hepatocellular Carcinoma, Thrombosis, Portal Vein Invasion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: There was recruted subject
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 30 Aug 2012 (actual)
- First posted
- 24 Sep 2012 (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.
A retrospective study based on analysis of medical records of patients with hepatocellular carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with diagnosis confirmed by imaging or histological specimen underwent surgical resection with curative intent. The study aims to determine the prognostic value of vascular complications related to cancer and to evaluate the survival rate of these patients, comparing the data with those reported in the literature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma underwent surgery | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection with curative intent with the presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels.
Key inclusion criteria (2 listed)
- hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection, with or without hepatic cirrhosis association;
- presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels;
Key exclusion criteria (3 listed)
- Patients undergoing prior systemic treatment;
- Patients presenting incomplete data that do not allow their classification according to the stratification models;
- Patients whose information of progression or death can not be recovered;
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
Prognosis (disease graduation)
Time frame: 1 to 3 years
The carcinoma prognosis in the presence of vascular complications related to cancer, characterized by invasion or portal vein thrombosis.
2 secondary outcomes
Survival rate in years
Time frame: 1 to 3 years
Relation established between survival and degree of underlying liver dysfunction
Time frame: 1 to 3 years
Results and safety
The study was stopped early (reason given: There was recruted subject). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Portal Vein Thrombosis, run by Hospital Sirio-Libanes at 1 site in Brazil.
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 2 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: stopped early, as of the sponsor's last update on 22 Nov 2023. 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 Brazil. 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 was stopped early (reason given: There was recruted subject). Results are not available in the source record.
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?
Prognosis (disease graduation) (time frame: 1 to 3 years). 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 22 Nov 2023.