Biomarkers for Cancer Treatment
Characterising Circulating Biomarker Signatures From Diverse Cancer Treatment Modalities - A Pilot Study
Circulating biomarkers, such as miRNAs and proteomics, undergo identifiable and measurable changes during and following treatment for cancer, compared to pre-treatment baseline. Some of these changes may be associated either with known treatment parameters or predictive for cardiac or lung toxicity.
The aim is to identify and validate changes following treatment for cancer, compared to pre-treatment baseline, as well as differential miRNA expression in two-group comparisons (patients receiving radical RT/chemoRT for thoracic cancers versus IO-based complex SACT).
調査の概要
状態
条件
詳細な説明
To identify and validate changes in miRNA pre- and post- radical RT/chemo-RT (cohort 1) and pre- and post- IO-based complex SACT (cohort 2) and elucidate links between dysregulated miRNAs and clinical evaluations.
To identify and validate changes in protein biomarker profile (1,034 protein targets) pre- and post- radical RT/chemo-RT (cohort 1) and pre- and post- IO-based complex SACT (cohort 2) and to elucidate links between changes in proteins relevant to immune and inflammatory pathways and clinical evaluations.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Hardip Sandhu, MBA, BSc, MSc, PhD
- 電話番号：+442477 659305
- メール：ab1682@coventry.ac.uk
研究場所
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Coventry、イギリス、CV2 2DX
- 募集
- University Hospitals Coventry & Warwickshire NHS Trust
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主任研究者：
- Raj Shrimali
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コンタクト：
- Raj Shrimali, MBBS, FRCR, FRCP, PhD
- 電話番号：+44 2476 966197
- メール：Raj.Shrimali@uhcw.nhs.uk
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コンタクト：
- Sean James
- 電話番号：+442476 965248
- メール：sean.james@uhcw.nhs.uk
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Adult patients (Age >18 years)
- Histologically/Cytological confirmed solid tumour
- Treated with radical RT or concurrent chemo-RT (Cohort 1) OR
- Treated with chemo-IO or IO-IO combination (Cohort 2)
- First-line treatment
- Able to provide informed consent
- Willing to comply with study procedures
Exclusion Criteria:
- Contraindication for RT or chemotherapy (Cohort 1) OR
- Contraindication for chemotherapy or IO (Cohort 2)
- Use of chemotherapy or immunotherapy in the last 5 years. (Cohort 1) OR
- Use of radical RT or chemo-RT within the thorax in the last 5 years. (Cohort 2)
- Beyond first-line treatment (second line onwards)
- Has more than 1 active cancer requiring treatment
- Recent participation in an interventional study
- Pregnant or breastfeeding women
- On long term cytotoxics or immune-modulators for rheumatoid arthritis or connective tissue disorders or auto-immune disorders
- Poor life expectancy, likely less than 6 months
- Patients not likely to comply with treatment or the study
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 |
|---|
|
Patients treated with RT
Patients treated with curative-intent RT/chemo-RT for lung or oesophageal cancer
|
|
Patients treated with SACT
Patients treated with IO-based complex SACT for any malignant solid tumour
|
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 |
|---|---|---|
|
Blood results
時間枠：Baseline visit
|
Identifying and validating changes in miRNA expression
|
Baseline visit
|
|
Blood results
時間枠：12 week follow-up visit
|
Identifying and validating changes in miRNA expression
|
12 week follow-up visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood results
時間枠：Baseline visit
|
Identifying and validating changes in protein biomarker profiles
|
Baseline visit
|
|
Blood results
時間枠：12 week follow-up visit
|
Identifying and validating changes in protein biomarker profiles
|
12 week follow-up visit
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。