跳至主要内容
临床试验/NCT06181929
NCT06181929招募中不适用

A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females Who Are Never Smoker with a Family History of Lung Cancer

Sang-Won Um2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Lung cancer detection rate

研究概览

简要总结

This is a single-arm prospective pilot study in a single institution. The target accrual is 200 participants of Korean, female sex, never smoker status, and family history of lung cancer. The study will aim to enroll 200 participants in two years.

详细描述

Interested individuals will contact a research coordinator who will help to assess for study eligibility. Individuals who are eligible and able to sign informed consent will then proceed to have a LDCT screening exam with a result reported by a radiologist approved to read lung cancer screening scans. Results of this screening test will be discussed with the subject and further recommendations will be given. Negative results will proceed to have repeat LDCT exams for two additional years. Positive results will be recommended to have further diagnostic work-up, and possible treatment. Those with positive findings may be recommended to repeat a LDCT at varied intervals (e.g. at 3 months, at 6 months, etc.) per Lung-RADS recommendations which can be conducted as a research LDCT or as standard-of-care.

In addition, blood draw collection for a plasma-based assay will be collected at baseline, first year and second year for all patients along with the repeated LDCT scans.

A medical history questionnaire containing questions regarding ethnicity, family history of lung cancer, environmental exposures including secondhand smoke exposure, and a residential district to estimate the exposure of PM2.5 or PM10 will be given to the patient at the initial visit after informed consent has been obtained (Appendix A). Questionnaire can be collected within 1 month from the baseline consent.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
45 Years 至 74 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 45-74 years old
  • Korean female
  • Never smoker defined as a lifetime exposure of less than 100 cigarettes
  • Family history of lung cancer at first degree relatives (parents, siblings, or children)

排除标准

  • Prior history of lung cancer.
  • Diagnosis of any cancer within the past five years
  • Participation in a cancer prevention trial.
  • Present symptoms suggestive of current lung cancer, including: unexplained weight loss of over 5 kilograms within the last 12 months or unexplained hemoptysis.
  • Medical or psychiatric condition precluding informed medical consent.
  • History of LDCT screening, chest CT, PET or PET/CT scan within 10 years

研究组 & 干预措施

intervation group

Experimental

LDCT screening exam

干预措施: Low dose CT (Diagnostic Test)

结局指标

主要结局

Lung cancer detection rate

时间窗: up to 2years

detection rate

次要结局

  • Estimation of the Early Detection Rate of Lung Cancer in Liquid Biopsy(up to 2years)
  • incidence of lung cancer(up to 2years)
  • distribution of lung cancer stages(up to 2years)

研究者

发起方
Sang-Won Um
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sang-Won Um

professor

Samsung Medical Center

研究点 (2)

Loading locations...

相似试验