Hepatocellular CarcinomaHCCNCT00842647
Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2006to Aug 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between July 2006 and July 2009 1. All the patients who receive hepatomy in our department 2. Diagnose as HCC 3. Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines 4. No history of previous treatments 5. No pathological diagnosis before treatment
Who may be able to join
- All the patients who receive hepatomy in our department
- Diagnose as HCC
- Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines
- No history of previous treatments
- No pathological diagnosis before treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Min-Shan Chen, MD, 86-2087343117, Chminsh@mail.sysu.edu.cn
Min-Shan Chen, MD
About this study
This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Sensitivity, specificity, positive rate, negative rate
- Medical subject headings
- Carcinoma, Hepatocellular, Hypersensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJul 2006
- Primary completionJul 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842647
- Sponsor's protocol ID
- HCC05
- Acronym
- HCC
- Status last verified
- Apr 2009
- First submitted
- 11 Feb 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bruix J, Sherman M. Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005;42:1208-1236 Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108. Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol 2001;35:421-430. Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: incidence and risk factors. Gastroenterology 2004;127:S35- S50.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00842647
- Acronym / sponsor ID
- HCC / HCC05
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Sensitivity, specificity, positive rate, negative rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Jul 2006
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 12 Feb 2009 (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.
This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for hepatocellular carcinoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between July 2006 and July 2009 1. All the patients who receive hepatomy in our department 2. Diagnose as HCC 3. Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines 4. No history of previous treatments 5. No pathological diagnosis before treatment
Key inclusion criteria (5 listed)
- All the patients who receive hepatomy in our department
- Diagnose as HCC
- Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines
- No history of previous treatments
- No pathological diagnosis before treatment
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
- BackgroundBruix J, Sherman M. Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005;42:1208-1236 Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108. Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol 2001;35:421-430. Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: incidence and risk factors. Gastroenterology 2004;127:S35- S50.
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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.
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 Sun Yat-sen University at 1 site in China.
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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 8 Apr 2009. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Shan Chen, MD (86-2087343117 ext. 86-2087343117, Chminsh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00842647, which also lists 1 linked publication.
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 Apr 2009.