Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: LDCT Screening in Non-smokers in Taiwan

Summary: This study utilizes the low dose computed tomography(LDCT) to detect the occurrence of early lung cancer among non-smokers in Taiwan. Subjects who have family history of lung cancer or have high risk exposures to lung cancer will be recruited to participate LDCT screening and followed up for their possible occurrence of lung cancer.

Detailed description: Lung cancer ranks the No. 1 lethal cancer in Taiwan, with a five-year survival rate (5-yr SR) of only 15%. Most of the patients with early lung cancer are asymptomatic, while 75% of patients with cancer-related symptom at diagnosis have local or distant metastasis. Compared to a 5-yr SR of 70-90% in stage I/II lung cancer, the 5-yr SR in late stage IIIb/IV is less than 15%. Despite the progress in pharmaceutical treatment for late stage disease, early detection is still the only way to improve the outcome and even cure of this potentially lethal disease. Low dose computed tomography (LDCT) in recognized as the best tool available for early diagnosis of lung cancer. However, the radiation exposure, high cost and high false-positive rate are the major concerns to adapt this detection tool to general population. Recent studies from Europe and US have shown that LDCT screening in high-risk cigarette smoking population can effectively reduce lung cancer mortality. However, the major type of lung cancer in Taiwan is adenocarcinoma, which commonly occurs in non-smoker. Therefore, the risk prediction model generated from studies of western countries may not be suitable for directly adapted to our country. LDCT screening for lung cancer detection in non-smoker remains a controversial issue worldwide, including Taiwan. Facing the unmet need, it is urgent to establish the risk assessment model to predict lung cancer risks in non-smokers and to evaluate the efficacy of LDCT screening in non-smoker high-risk population. There are three specific aims in our proposed study and will be carried out in three phases. The first (pilot) phase (from 2014 to 2015, 14 months), aims to establish the LDCT screening protocol and risk assessment model for lung cancer prediction. 4500 subjects will be enrolled for first LDCT screening, preliminary result will be analyzed. The second phase (from 2016-2017, 24 months) considers to perform follow up LDCT and enroll another 7500 subjects for LDCT screening and follow up. The fine tuning of LDCT screening protocol and risk assessment model will be performed. The third phase (from 2018-2019, 24 months) is to complete the image and clinical follow up of all the subjects, the detection rate of lung cancer, false-positive rate, and cost-effectiveness analysis of LDCT screening for non-smoker lung cancer in Taiwan will be established.
  Aim 1: To evaluate the risk assessment model for predicting lung cancer in non-smokers According to the results of LDCT screening, we expect to improve the risk prediction model for nonsmoker female established by GELAC study. The revised risk model will help recognizing higher risk population.
  Aim 2: To establish the protocol for LDCT screening pilot study in Taiwan Establishing working protocol and procedures of LDCT screening to assure a homogeneous behavior among study sites
  Aim 3: To establish the efficacy of LDCT screening for lung cancer in non-smoker Lung cancer detection rate, false-positive rate, and cost-effectiveness analysis of LDCT screening for non-smoker lung cancer in Taiwan will be established.

Eligibility: Inclusion Criteria:
  Subjects who are
  1. Never smokers or have smoked less than 10 pack-years and quitted smoking over 15 years.
  2. One of the following conditions:
  (1)with family history of lung cancer within 1st, 2nd or 3rd degree relatives (2)with exposure history of environmental tobacco smoke in workplace or in home (3)history of lung disease (Tuberculosis or COPD) (4)the index of cooking frequency over than or equal to 110 (index of cooking frequency= 2/7 x（days of using saute, fry, or deep-fried a week）x（cooking years） (5)cooked without using cooking hoods (6)age from 55 to 75 years-old (subjects who have family history of lung cancer and were older than index case in family can be recruited in even they are less than 55 years-old
  Exclusion Criteria:
  Subjects who will be excluded from our study with following conditions,
  1. with history of lung cancer, or with cancers except skin cancer or cervical carcinoma in situ in past 5 years
  2. can not accept thoracentesis or surgery
  3. have been examined by chest computed tomography in 18 months
  4. have unexplained Hemoptysis in one month
  5. weight loss over than 6 kg with unexplained reason among one year
  6. pregnant

Relevance to patient case: not relevant