Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy (BioACT)
Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.
This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Manchester、イギリス、M20 4BX
- The Christie NHS Foundation Trust
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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:
- Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin [Aapro et al, 2011a].
- Age 18 or older
- Performance Status 0-2
- Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
Exclusion Criteria:
- Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
- Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
- Radio-immunotherapy within the last 8 weeks.
- Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) [Gonzalez-Quintela et al, 2009, Lavallard et al, 2011]
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
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 |
介入・治療 |
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Biomarker and health economics
Biomarkers will be taken throughout cycle 1.
Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use.
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Biomarkers CK18 and FLT3 Ligand will be collected
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
時間枠：day 3
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to confirm in a prospective cohort whether changes in CK18 and FLT3 ligand at day 3 of chemotherapy can identify patients at risk of subsequent severe chemotherapy toxicity
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day 3
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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number of hospital admissions for febrile neutropenia
時間枠：end of chemotherapy at approximately 6 months
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end of chemotherapy at approximately 6 months
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Total number of overnight stays or stays in A&E of over 4 hours spent in hospital
時間枠：End of study chemotherapy at approximately 6 months
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End of study chemotherapy at approximately 6 months
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Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy
時間枠：End of chemotherapy at approximately 6 months
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End of chemotherapy at approximately 6 months
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Number of total days delay in receiving chemotherapy treatment compared to planned delivery
時間枠：end of chemotherapy at approximately 6 months
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end of chemotherapy at approximately 6 months
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Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires
時間枠：cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
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cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
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Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors
時間枠：end of study chemotherapy at approximately 6 months
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end of study chemotherapy at approximately 6 months
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協力者と研究者
捜査官
- スタディチェア：Alastair Greystoke、The Christie NHS Foundation Trust
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)
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
- 11_DOG05_99
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Biomarker and health economicsの臨床試験
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VA Office of Research and Developmentまだ募集していません
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University of BirminghamNational Institute for Health Research, United Kingdomわからない