Evaluation of Proteasome as a Marker of Hepatocellular Carcinoma in Cirrhotic Patients Following Curative Treatment
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Purpose
This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of hepatocellular carcinoma (HCC) by studying their variation following curative treatment of HCC. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence.
| Condition | Intervention |
|---|---|
|
Hepatocellular Carcinoma Cirrhosis |
Biological: No apllicable |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients |
- Variation of plasma proteasome [ Time Frame: 3 months afterwards ] [ Designated as safety issue: No ]Variation of plasma proteasome levels before curative treatment of HCC and 3 months afterwards
- Variation of plasma proteasome [ Time Frame: 6, 9 and 12 months ] [ Designated as safety issue: No ]Variation of plasma proteasome levels 6, 9 and 12 months following curative treatment for HCC, comparison with AFP levels and results from imaging studies
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: carcinoma in cirrhotic patients
Not applicable
|
Biological: No apllicable
No apllicable
Other Name: No apllicable
|
Detailed Description:
HCC occurs in the vast majority of cases in the context of cirrhosis. Cirrhosis is considered a pre-cancerous state, which justifies systematic screening for HCC. Screening currently relies on measurement of alpha-foetoprotein (AFP) levels and ultrasound scans every 4 to 6 months. However, AFP has poor sensitivity as a marker for HCC. We have recently shown that plasma proteasome levels have a higher sensitivity than HCC for detecting HCC in cirrhotic patients, particularly when the tumors are small and can still benefit from curative treatment. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence. The goal of this study is to determine whether plasma proteasome levels in cirrhotic patients with HCC decrease following curative treatment (radiofrequency, surgical resection, liver transplantation). Plasma proteasome levels will be measured before treatment and 3 months after treatment, then subsequently at 3 month intervals over one year following treatment. The variation of proteasome levels will be compared to AFP levels. The sensitivity of proteasome as a marker to detect tumor recurrence will be evaluated, and compared to AFP.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cirrhotic patients with hepatocellular carcinoma proven by histological examination of a biopsy specimen, eligible for curative treatment (radiofrequency, surgical resection, liver transplantation)
- Patient able to give informed consent
- Patient with Social Security coverage
Exclusion Criteria:
- Secondary liver tumors
- Non hepatocellular carcinoma primary liver tumor
- Hepatocellular carcinoma without cirrhosis
- Patients with hepatocellular carcinoma and cirrhosis not eligible for curative treatment
- Prisoners
- Adults under guardianship or curatorship
- Pregnancy
Contacts and Locations| Contact: Natalie FUNAKOSHI | 33 4 67 33 70 63 | n-funakoshi@chu-montpellier.fr |
| France | |
| UH Montpellier | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Natalie Funakoshi 33 4 67 33 70 63 n-funakoshi@chu-montpellier.fr | |
| Principal Investigator: Natalie funakoshi | |
| Principal Investigator: | Natalie Funakoshi | University Hospital, Montpellier |
More Information
Publications:
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01492127 History of Changes |
| Other Study ID Numbers: | UF 8671 |
| Study First Received: | December 12, 2011 |
| Last Updated: | April 3, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Montpellier:
|
Hepatocellular carcinoma cirrhosis proteasome alpha-fetoprotein |
Additional relevant MeSH terms:
|
Carcinoma Liver Cirrhosis Fibrosis Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Liver Diseases Digestive System Diseases Pathologic Processes Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 16, 2013