Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19) (CARDS)
調査の概要
状態
条件
詳細な説明
Patients with cancer are thought to have a weakened immune system and small observational case series have suggested patients with cancer are at a higher risk of poor outcome from COVID-19. However, the clinical course of COVID-19 infection amongst cancer patients is not known. In addition, it is unclear when it is appropriate for cancer patients who have recovered from COVID-19 infection to resume anti-cancer therapy.
There is unmet need for diagnostic assays for COVID-19 including tests which can rapidly determine whether the virus has been cleared of the COVID-19. Lateral flow assays investigated in this study are rapid and simple diagnostic tools which can assist in timely diagnostics to inform clinical decision making.
This observational study aims to describe the immunological dynamics and clinical course of COVID-19 in cancer patients and evaluate COVID-19 antibody and antigen lateral flow assays.
The information from our study will add significantly to the understanding of COVID-19 diagnostics and will improve the evidence-base for the management of cancer patients. Furthermore, data from this study could inform the timing and treatment for cancer patients who have recovered from COVID-19 infection.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Surrey
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Sutton、Surrey、イギリス、SM2 5PT
- The Royal Marden 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:
- Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 RT-PCR
- Metastatic or advanced solid organ malignancy, including lymphoma OR Early stage solid organ malignancy having received therapy (radiotherapy, chemotherapy or targeted agents)
- Patient is ≥ 18 years of age.
- Patient can understand the patient information sheet and is able to provide written informed consent.
Exclusion Criteria:
- There are no exclusion criteria for this 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 |
介入・治療 |
|---|---|
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Arm A
Suspected acute COVID-19 infection
|
Throat/nose swabs will initially be collected at baseline (D0) as part of the diagnostic workup for SARS-CoV-2 infection.
Subsequent throat/nose swabs will be taken at D7 (if an inpatient), D14, D28, D42 and D56.
Two samples will be taken, one for standard of care testing and one for lateral flow assay and storage for further analysis later such as quantitative PCR.
Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5mL) will be collected.
Saliva will be tested by the lateral flow assay when available and excess material stored.
Approximately 30mL of blood will be taken at each study visit.
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Arm B
Asymptomatic patients with no clinical suspicion of COVID-19
|
Approximately 30mL of blood will be taken at each study visit.
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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 |
時間枠 |
|---|---|
|
Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2.
時間枠：56 days
|
56 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical course of SARS-CoV-2 infection in cancer patients.
時間枠：56 days
|
Duration of clinical symptoms
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56 days
|
|
Clinical course of SARS-CoV-2 infection in cancer patients.
時間枠：56 days
|
Severity of clinical symptoms
|
56 days
|
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Clinical course of SARS-CoV-2 infection in cancer patients.
時間枠：56 days
|
Number of patients whose cancer treatment has been impacted by SARS-CoV-2
|
56 days
|
|
Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR.
時間枠：56 days
|
56 days
|
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Time from start of symptoms to Day 0 testing in the study.
時間枠：56 days
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56 days
|
|
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Feasibility of SARS-CoV-2 testing with a lateral flow assay.
時間枠：56 days
|
|
56 days
|
協力者と研究者
協力者
捜査官
- 主任研究者：Sheela Rao, MD FRCP、Royal Marsden NHS Foundation Trust
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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
- CCR 5287
- 20/NE/0139 (その他の識別子：Research Ethics Committee)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
Throat/nose swabsの臨床試験
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Carmel Medical CenterTechnion, Israel Institute of Technology完了
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Memorial Sloan Kettering Cancer CenterUNIVERSITY CAMPUS BIO-MEDICO, ITALY募集
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Carmel Medical CenterTechnion, Israel Institute of Technology完了
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Seoul National University Bundang Hospital完了泌尿器科の新生物 | 部位別新生物 | 消化器腫瘍 | 結腸直腸腫瘍