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.
調査の概要
状態
研究の種類
入学 (予想される)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
HCV lymphoma patients with chemotherapy
Lymphoma patients who are positive for anti-HCV and are planning to receive chemotherapy for lymphoma
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy
時間枠：one year
|
one year
|
|
Number of Participants with Detectable Viremia and Developing Hepatitis after Chemotherapy
時間枠：one year
|
one year
|
|
Interval (months) between Peak HCV RNA Level and Hepatitis
時間枠：one year
|
one year
|
|
Increase (log) of HCV Viral Load between Baseline and after Chemotherapy
時間枠：one year
|
one year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with Hepatitis after Chemotherapy
時間枠：one year
|
Hepatitis is defined as ALT level > 2.5X ULN
|
one year
|
|
Number of Participants with Severe Hepatitis after Chemotherapy
時間枠：one year
|
Severe hepatitis is defined as ALT level > 5X ULN or Bilirubin level > 3.0X ULN
|
one year
|
|
Number of Participants with Chemotherapy Interruption due to Hepatotoxicity
時間枠：one year
|
one year
|
|
|
Number of Participants with Early Stop of Chemotherapy due to Hepatotoxicity
時間枠：one year
|
one year
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 103-7486B
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