CTRI/2023/01/048765招募中不适用
Collection of blood and sputum samples from healthy subjects and patients with lung cancer for characterization of cancer biomarkers to develop an early-stage liquid biopsy-based cancer screening test.
Oxford Cancer Analytics14 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2023年6月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 14
- 主要终点
- there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.
研究概览
简要总结
Currentstudy protocol will combine unique machine learning, proteomic, and geneticapproaches to develop a cost-effective and minimally invasive liquidbiopsy-based test for lung cancer detection. State-of-art mass spectrometryproteomics supplemented by genetic approaches will be applied to provide acomprehensive understanding of liquid biopsy biomarkers (blood and sputum) inpatients with high risks for lung cancer. A key innovation in this study is theability to analyze up to thousands of proteins (~5,00- 2,000) and select for apanel of succinct protein biomarkers. Past studies have not analyzed liquidbiopsy proteins at this level of depth and quantity for lung cancer. Massspectrometry will further enable the analysis of post-translationalmodifications present in liquid biopsy proteins that could be critical for lungcancer early detection and monitoring.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Cohort I:
- •Male and/or female subjects aged 50-80 years.
- •Weight not less than 50 kg for male and 45kg for female.
- •Subjects who smoke cigarettes daily for at least 20 years (not necessarily 20 years in a row).
- •Subjects with smoking history of at least 20 pack-years (can be discontinuous).
- •(Pack-year is a way to measure the amount a person has smoked over a long period of time.
- •It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
- •For example, 1 pack year is equal to smoking 1 pack per day for 1 year, or 2 packs per day for half a year, and so on)
- •If former smoker, the subject has quit smoking within the past 15 years.
- •Subjects who have not gone through treatments (surgery, drugs, radiation).
- •Subjects or Legally Acceptable Representative (for the subjects with low literacy) who provides informed consent.
- •Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, 12 Lead Electrocardiogram (12 Lead ECG), chest X-Ray and laboratory evaluations (haematology, serum chemistry, urine analysis).
- •Cohort II and Cohort III:
- •Stage I/II lung cancer (Cohort II Only) b.
- •Stage III/IV lung cancer (Cohort III Only)
- •Male and/or female patients aged 50-80 years.10
- •Patients with smoking history of at least 20 pack-years.
- •Patients who have not gone through treatment (surgery, drugs, radiation).
排除标准
- •Cohort I:
- •Subjects with the habit of tobacco chewing.
- •Subjects with previous diagnosis of lung cancer.
- •Subjects with previous history of any kind of cancer diagnosis.
- •Subjects who have completed treatments related to any kind of cancer (surgery, drugs, radiation).
- •Subjects with recent myocardial infarction (MI) history (within 6 months).
- •Subjects having history or presence for disease markers of Human Immunodeficiency Virus 1 (HIV 1) and 2, Hepatitis B and C and Rapid Plasma Reagin (RPR) test for Syphilis.
- •Subject having difficulty in accessibility of veins for blood sampling and or difficulty with donating blood.
- •Subjects having hypersensitivity toward Albuterol.
- •Matched plasma and sputum samples from the same subject is required for the study.
- •Priority will be given to the plasma (blood) if sputum is unavailable.
- •Female subjects found to be positive during pregnancy test done prior to commencement of study.
- •Lactating females.
- •Any other medical condition, as per the discretion of the investigator, precludes the subject’s participation in the study.
- •Cohort II and Cohort III:
- •Patient with the habit of tobacco chewing.
- •Patient with previous diagnosis of lung cancer except stage IV in case of metastasis (spread of cancer to other parts of body).
- •The patient can be included in the stage IV (Cohort III) in case of metastasis.
- •Patient with previous history/treatment of any kind of cancer.
- •Patients who have completed treatments for any kind of cancer (surgery, drugs, radiation).
- •Patients having history or presence for disease markers of HIV 1 and 2, Hepatitis B and C and RPR test for Syphilis.
- •Patients having difficulty in accessibility of veins for blood sampling and or difficulty donating blood
- •Matched plasma and sputum samples from the same patient are required for the study.
结局指标
主要结局
there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.
时间窗: there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.
次要结局
- there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.(there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.)
研究者
研究点 (14)
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