Viral Load Changes in Lymphoma Patients With HCV Infection After Chemotherapy
Serial Viral Load Changes and Hepatotoxicity in Lymphoma Patients With Hepatitis C Antibody After Chemotherapy Treatment: A Prospective Multicenter Observational Study and Long-term Retrospective Analysis
In last few years, most researches about hepatic complication after chemotherapy focused on hepatitis B virus (HBV). With adequate prophylaxis and monitor, HBV-related hepatitis flares can be prevented. In contrast, cancer patients with hepatitis C virus (HCV) infection are traditionally considered as relative safe to receive chemotherapy. However, two large retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma patients with chronic HCV infection, including 3-4% hepatic failure. The risk factors to predict severe hepatitis are pre-treatment elevated ALT level and liver cirrhosis. Due to the lack of prospective studies, the dynamic changes of serum HCV RNA levels and the association of hepatitis are still unclear.
Some epidemiologic studies demonstrated an association between HCV infection and B-cell lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma and several reports showed higher prevalence of HCV infection among DLBCL patients than the controls. HCV infected DLBCL patients are reported to have distinct clinical characteristics, such as older, more with elevated LDH levels, and more with extra-nodal involvement. Regarding the impact of HCV infection on prognosis, the results are conflicting. Taiwan is an endemic area of HCV but there are limited reports addressing the clinical characteristics and prognosis in this unique population.
Therefore, the investigators initiate a prospective, multi-center observational study to clarify the dynamic association between serum HCV RNA levels and hepatitis in HCV-infected lymphoma patients treated with chemotherapy.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Newly diagnosed histologically proven malignant lymphoma
- Eligible subjects must be positive for anti-HCV Ab
- Age ≥ 20 years
- Planned to receive chemotherapy
- No recent chemotherapy and radiotherapy in the past one year. Pre-enrollment steroids for symptomatic relief are allowed but less than equivalent dose to prednisolone total 140 mg
- Left expectancy ≥ 3 months
- Signed informed consent
- ECOG 0-2
Exclusion Criteria:
- Patients not willing to receive chemotherapy
- Chronic hepatitis B infection (positive for HBsAg), but those with resolved HBV infection (positive for anti-HBc and negative for HBsAg) are allowed
- Other major systemic diseases, such as active infection, significant cardiac disease, neurologic deficit or psychiatric disorders, that the investigators consider to be at significant risk
- Known human immunodeficiency virus (HIV) infection
- Pregnant or breast-feeding woman
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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HCV lymphoma patients with chemotherapy
Lymphoma patients who are positive for anti-HCV and are planning to receive chemotherapy for lymphoma
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy
Lasso di tempo: one year
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one year
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Number of Participants with Detectable Viremia and Developing Hepatitis after Chemotherapy
Lasso di tempo: one year
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one year
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Interval (months) between Peak HCV RNA Level and Hepatitis
Lasso di tempo: one year
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one year
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Increase (log) of HCV Viral Load between Baseline and after Chemotherapy
Lasso di tempo: one year
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one year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants with Hepatitis after Chemotherapy
Lasso di tempo: one year
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Hepatitis is defined as ALT level > 2.5X ULN
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one year
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Number of Participants with Severe Hepatitis after Chemotherapy
Lasso di tempo: one year
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Severe hepatitis is defined as ALT level > 5X ULN or Bilirubin level > 3.0X ULN
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one year
|
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Number of Participants with Chemotherapy Interruption due to Hepatotoxicity
Lasso di tempo: one year
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one year
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|
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Number of Participants with Early Stop of Chemotherapy due to Hepatotoxicity
Lasso di tempo: one year
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one year
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Linfoma
- Epatite
- Epatite A
- Epatite C
Altri numeri di identificazione dello studio
- 103-7486B
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