CTRI/2022/06/043487尚未招募不适用
Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non-contrast CT among PLHIV in Pune, India
TREAT Asia amfAR The Foundation for AIDS Research through a grant from the US NIH1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年4月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- a. Prevalent cases of lung nodules
研究概览
简要总结
This is a Study for Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non-contrast CT among PLHIV in Pune, India. The purpose of the study is is to Characterize the prevalance and risk of lung cancer using non-contrast computed tomography, and other pulmonary multimorbidity(chronic pulmonary diseases and pulmonary comorbidities among people living with HIV.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •a.Men, women, and transgender persons known to be PLHIV ≥18 years of age.
- •(Note: Participants must be able to show proof that they are living with HIV, either by having a unique treatment number associated with the BJGMC-SGH ART center or a government provided HIV treatment book.
- •A separate HIV test will not be performed in the study) b.Willingness to undergo at least one chest NCCT.
- •c.Ability of the participant to provide informed consent.
- •(Note: Illiterate participants will be enrolled based on local regulatory policies, with appropriate provisions for informed consent).
排除标准
- •a.Unwillingness to undergo at least one chest NCCT.
- •b.Having undergone a computed tomography (CT) of any part of the body, positron emission tomography (PET) or interventional radiology procedure (coronary angiography, angioplasty, etc.) within one year prior to the anticipated enrollment date.
- •c.Men, women or transgender PLHIV with cognitive, hearing or language impairment.
- •d.Men, women or transgender persons with unknown HIV status.
- •e.Men, women or transgender PLHIV with a history of lung cancer or having received treatment for lung cancer in the past.
- •f.Pregnant women.
- •g.Inability/ Unwillingness to provide informed consent.
结局指标
主要结局
a. Prevalent cases of lung nodules
时间窗: a. end of 4th year | b. end of 3rd year
b. Incident cases of lung nodules
时间窗: a. end of 4th year | b. end of 3rd year
次要结局
- a. Overall prevalence of chronic obstructive pulmonary disease (COPD)(b. Incident cases of COPD)
研究者
研究点 (1)
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