Circulating EV Long RNA Profiles in SCLC
Circulating Extracellular Vesicle Long RNA Profiles in the Diagnosis and Prediction of Treatment Response for Small Cell Lung Cancer
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Jialei Wang, Doctor
- 電話番号:18017312369
- メール:luwangjialei@126.com
研究場所
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Shanghai
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Shanghai、Shanghai、中国、200032
- 募集
- Cancer hospital Fudan University
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コンタクト:
- Jia lei Wang, Master
- 電話番号:8907 02164175590
- メール:luwangjialei@hotmail.com
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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
説明
Inclusion Criteria:
- Patients volunteered to participate in the study and have signed the informed consent.
- Histological or cytological diagnosis of small cell lung cancer, and no indication of radical surgery or radiotherapy.
- There are measurable lesions defined by RECIST standard v1.1. A lesion can be considered measurable only if the previously irradiated lesion has clear progression after radiotherapy and the previous irradiated lesion is not the sole lesion.
- Initially treated patients who have not received any systematic therapy before. If have received postoperative adjuvant chemotherapy, the time to relapse is at least 6 months from the last adjuvant chemotherapy.
- 18~75 years old; ECOG PS score: 0~1 points; expected survival time is more than 3 months.
- The main organs's function meets the following criteria within 14 days before treatment:
(1)Routine blood test (without blood transfusion within 14 days): a) Hemoglobin (HB) ≥ 90 g / L; b) Absolute neutrophil (ANC) ≥ 1.5 × 109 / L; c) Platelets (PLT) ≥ 80×109/L (2)Biochemical examination: a) Total bilirubin (TBIL) ≤ 1.5 times of the upper limit of the normal (ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5ULN.To patients with liver metastasis, ALT and AST ≤ 5ULN; c) Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; (3)Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ the lower limit of the normal (50%).
7. Patients with previously treated asymptomatic CNS metastases are allowed to participate in this study if all of the following criteria are met: a) No need for continuous corticosteroid therapy for CNS disease; b) No radiotherapy within 14 days prior to enrollment treatment; c) Imaging examination from the end of radiotherapy to screening period shows no CNS progression.
8. Women of childbearing age should agree to conduct contraception (such as intrauterine devices, contraceptives or condoms) during the study and within 6 months after the end of the study; and the serum or urine pregnancy test is negative within 7 days prior to study enrollment and they must be non-lactating patients; Men should agree to conduct contraception during the study and within 6 months after the end of the study.
Exclusion Criteria:
- Histological or cytological diagnosis of small cell and non-small cell mixed lung cancer.
- Patients who have previously received systemic chemotherapy, signal transduction inhibitors, targeted therapies, hormone and endocrine therapy.
- Patients with other malignant tumors occurred within 5 years prior to the enrollment, except those with cured cervical carcinoma in situ and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)] , basal or squamous cell skin cancer, and localized prostate cancer and ductal breast carcinoma in situ treated with radical surgery.
- Unresolved toxicity due to any previous treatment above CTC AE (4.0) level 2 or higher, excluding hair loss.
- Patients with symptomatic CNS metastases.
- Patients with uncontrolled pleural, pericardial, or peritoneal effusion requiring repeated drainage.
Patients with any severe and/or uncontrolled disease, including:
- Patients with unsatisfactory blood pressure control (systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg).
- Patients with myocardial ischemia or myocardial infarction of Grade I of higher level, arrhythmia (including QTC ≥ 440ms) and congestive heart failure above Grade 2 (New York Heart Association (NYHA) classification).
- Patients with active or uncontrolled severe infection (≥ CTC AE Level 2).
- Patients with a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
- Patients with poor control of diabetes (fasting blood glucose (FBG)>10mmol/L).
- Patients with urine protein ≥ ++ indicated by routine urine test, and confirmed 24-hour urine protein quantitation > 1.0 g.
- Patients with seizures requiring treatment.
- Patients undergone venous thrombosis events currently or within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
- Patients with a history of psychotropic drug abuse from which they are unable to abstain or with mental disorders.
- Patients who have participated in other clinical trials of anti-tumor drugs within four weeks.
- Patients with severe disease that threaten the safety of themselves or affect the completion of the study according to the investigators' judgment.
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
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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他の:Small Cell Lung Cancer receiving chemotherapy
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Baseline blood samples are collected before chemotherapy.
Dynamic blood samples are also prospectively collected after 2~4 cycles of chemotherapy, or at the time of disease progression.
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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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Establish a model to predict curative effect
時間枠:At the end of Cycle 4 (each cycle is 21 days)
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To detect the difference of exLR profiles of SCLC patients before and after treatment, and the difference of baseline exLR profiles between responders and non-responders.
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At the end of Cycle 4 (each cycle is 21 days)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (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。
Blood sample collectionの臨床試験
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Cliniques universitaires Saint-Luc- Université...Université de Liège募集
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The Institute of Molecular and Translational Medicine...Cancer Research Czech Republic完了
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University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National Human Genome... と他の協力者完了新生児スクリーニング
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Ischemia Care LLC完了虚血性脳卒中 | 心房細動 | 血栓性脳卒中 | 一過性脳虚血発作 | 心塞栓性脳卒中 | 脳底動脈の脳卒中 | 一過性脳血管イベントアメリカ
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Applied Science & Performance Institute完了