Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV lymphoma patients with chemotherapy | Lymphoma patients who are positive for anti-HCV and are planning to receive chemotherapy for lymphoma |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy | one year | |
| Number of Participants with Detectable Viremia and Developing Hepatitis after Chemotherapy | one year | |
| Interval (months) between Peak HCV RNA Level and Hepatitis | one year | |
| Increase (log) of HCV Viral Load between Baseline and after Chemotherapy | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Hepatitis after Chemotherapy | Hepatitis is defined as ALT level > 2.5X ULN | one year |
| Number of Participants with Severe Hepatitis after Chemotherapy | Severe hepatitis is defined as ALT level > 5X ULN or Bilirubin level > 3.0X ULN |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Lymphoma patient plus hepatitis C
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Peripheral blood mononuclear cells
| one year |
| Number of Participants with Chemotherapy Interruption due to Hepatotoxicity | one year |
| Number of Participants with Early Stop of Chemotherapy due to Hepatotoxicity | one year |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |