Lung Cancer Screening Standards in China

PrefacePreface

This document was drafted in accordance with the provisions of GB/T 1.1-2020 “Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents”.
This document was proposed by the National Cancer Center.
This document is attributed by the Chinese Society of Preventive Medicine.
This document is drafted by: National Cancer Center, Nanjing Medical University, Peking Union Medical College, Cancer Hospital Shenzhen, Chinese Academy of Medical Sciences, China Medical University, Lanzhou University, Yunnan Cancer Hospital, Shanxi Cancer Hospital, Shandong Cancer Hospital, Zhejiang Cancer Hospital.
The main drafters of this document: He Jie, Shen Hongbing, Chen Wanqing, Wu Ning, Jiang Yu, Zhou Baosen, Li Ni, Huang Yunchao, Gong Jiyong, Liu Shiyuan, Chen Qihang, Zhao Shaohong, Guo Youmin, Wu Jianlin, Tan Fengwei, Ma Hongxia, Ying Jianming, Huang Yao, Tang Wei, Li Wenbin, Zhao Shijun, Li Jiang, Wang Fei, Zhang Juan, Tian Jinhui, Du Lingbin, Zhang Yongzhen.

IntroductionIntroduction

Lung cancer is one of the most common malignant tumors, ranking first in incidence and death from malignant tumors worldwide and in China. Recent studies have shown that lung cancer mortality is reduced by 24% in men and 33% in women with low-dose spiral CT screening. Currently, most of the scientific evidence guiding lung cancer screening comes from studies in Europe and the United States, while the epidemiological characteristics of lung cancer in China are different from those in Europe and the United States, such as the high proportion of non-smoking women, so it is not appropriate to copy foreign experience in lung cancer screening in China. The establishment of this document will greatly promote the homogeneity and quality of lung cancer screening in China, improve the efficiency and effectiveness of lung cancer screening, and is the basis and guarantee of lung cancer prevention and control in China.
Lung Cancer Screening Standards in China

1 Scope

This document specifies the requirements related to the screening population, technology, process, quality control and the establishment of a screening resource base in the process of lung cancer screening.
This document applies to lung cancer screening conducted by medical institutions at all levels nationwide.

2 Normative References

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the reference document with the date, only the version corresponding to the date applies to this document; the reference document without the date, its latest version (including all the revision sheets) applies to this document.
GB/T 37864-2019 General requirements for the quality and capacity of biological sample repositories
T/CPMA 002-2019 Technical specifications for long-term follow-up of endpoint events in large population cohorts
T/CPMA 001-2018 Technical Specification for Data Processing of Large Population Cohort Studies

3 Abbreviations

The following abbreviations apply to this document.
DICOM: Digital imaging and communications in medicine (Digital imaging and communications in medicine)
LDCT: low-dose computed tomography (low-dose spiral CT)
MIP: maximum density projection (Maximum intensity projection)
MPR: Multi-planar reformation (MPR)
PACS: Picture archiving and communication systems (Picture archiving and communication systems)
PET-CT: Positron emission tomography- computed tomography (PET-CT)
VR: Volume rendering (VR)

4 Screening populations

Screening for lung cancer should be performed in a population at high risk for lung cancer. People at high risk for lung cancer are between (50 and 74) years of age and meet at least one of the following criteria.
a) Have smoked for not less than 30 (pack-years), including having smoked for not less than 30 (pack-years) but quit for less than 15 years.
b) Have lived with or worked in the same room as a) Passive smoking for more than 20 years.
c) Have chronic obstructive pulmonary disease (COPD).
d) Have a history of occupational exposure for not less than one year, including exposure to asbestos, radon, beryllium, chromium, cadmium, silica, soot and soot.
e) Have a first-degree relative with a confirmed diagnosis of lung cancer.
Note 1: Number of pack-years of smoking = number of packs smoked per day (20 packs per day) x number of years of smoking
Note 2: First-degree relatives refer to parents, children and siblings (same parents)

5 Screening TechniquesLung cancer screening should be performed with low-dose spiral CT (LDCT) and should not be performed with chest x-ray.

6 Screening process (see Appendix A)

7 Quality control

7.1 The following measures are appropriate for quality control of LDCT scans.
a) Training screening subjects to hold their breath prior to scanning.
b) Deposit all images in DICOM format to PACS.
7.2 The following measures are desirable for quality control of LDCT screening results.
a) Each screening report should be issued by an imaging physician with the title of attending or above.
b) For cases with suspected lung cancer or “malignant lesions”, detected intrapulmonary nodules of not less than 15.0 mm, or airway lesions requiring bronchoscopy and further tests such as puncture biopsy, at least one imaging physician with associate or full senior title should be involved.
c) When invasive diagnostics (e.g. bronchoscopy, percutaneous lung aspiration biopsy, etc.) and open-heart surgery are required, the images are discussed by two or more imaging physicians with associate or full senior title and the case is brought to the multidisciplinary expert group for discussion.
7.3 Periodically, 100% of cases with suspected lung cancer or “malignant lesions”, nodules no smaller than 15.0 mm, or airway lesions requiring bronchoscopy will be reviewed by an associate or senior imaging physician, and 1% of other cases will be randomly selected.
7.4 Quality control of screening subjects at follow-up should refer to Section 7 “Quality Control and Evaluation” in T/CPMA 002-2019.

8 Screening Resource Library

Where available, a lung cancer screening resource bank should be established, which should include a screening database, an imaging database, and a biospecimen bank. It is appropriate to establish the following requirements.
a) The screening database should include risk assessment data, LDCT screening data, clinical diagnosis and treatment data, and follow-up data. The type of data and privacy protection should refer to the fourth part of T/CPMA 001-2018 “Privacy Protection of Data from Large Cohort Studies”.
b) Screening LDCT images should be stored in DICOM format in the appropriate image repository; LDCT images should include 5 mm thick conventional images, (1.00-1.25) mm thin layer images, and “dose report” images.
c) For screening participants, it is appropriate to collect and store blood samples. If a biopsy is performed, it is advisable to keep the tissue sample, etc. The collection, transport and storage of specimens should refer to the requirements in GB/T 37864-2019.

Appendix A
(informative)
Lung cancer screening processThe flow of lung cancer screening is given in Figure A.1.

Figure A.1 Lung cancer screening process
# of pack-years of smoking = # of packs smoked per day (20 packs per day) x # of years of smoking
#first-degree relatives refer to parents, children, and siblings(same as parents)

Appendix B
(informative)
Lung Cancer Risk Assessment QuestionnaireLung Cancer Risk Assessment Questionnaire
Name: ________________ Sex: 1. Male 2. Female
Date of birth: _ _ (please fill in the solar birthday)
National origin: __ province city _ county (district)
Ethnicity: 1. Han Chinese 2. Mongolian 3. Hui 4. Manchu 5. Zhuang < strong>6. Uyghur 7. Kazakh 8. Other, please specify
ID number:
Personal contact number: (mobile)
Emergency contact phone number: (mobile)
Permanent address:
Workplace: ________________

A1.1. Age of onset of smoking

.
B1.1. Does the family member currently quit smoking? 0. no 1. yes
B1.2. If yes, has the family member quit smoking for less than 15 years? 0. no 1. yes
B1.3. How many cigarettes does the family member smoke on average per day?
B1.4. How many years has the family member smoked in total, minus the number of years of quitting?
.
A. Smoking status

A.
A1. Do you smoke (defined as smoking if you smoke more than one cigarette a day for more than 6 months continuously or cumulatively)?
0. no, never smoked (skip to B1)
1. yes, currently still smoking
2. used to smoke, now quit

A1.1.
A1.2. If you still smoke or have smoked, how many cigarettes per day (1 tael of tobacco ≈ 50 cigarettes)?

A1.3. If you still smoke or have smoked, how long have you smoked in total, minus the number of years you have quit smoking?

B1 A1.4.
B1 A1.4. If you currently quit smoking, how long has this quit lasted?

B.
B. Passive smoking status

B1. For nonsmokers, have you lived with a family member who smokes for more than 20 years?      0. no (skip to B2) 1. yes

B2. For non-smokers, has the family worked in the same room with a co-worker who smokes for more than 20 years?     0. No (skip to C1) 1. Yes

B2.1. Does this colleague currently quit smoking? 0. no 1. yes
B2.2. If yes, has the colleague quit smoking for less than 15 years? 0. no 1. yes
B2.3. How many cigarettes does this colleague smoke on average per day?
B2.4. How many years has this coworker smoked in total, minus the number of years he or she has quit?

.

C. Past history of chronic obstructive pulmonary disease

C1. Do you have chronic obstructive pulmonary disease (COPD)? 0. no 1. yes

D. History of occupational exposure

D.
D1. Do you have a history of occupational exposure to hazardous substances (1 year or more)?
0. no (skip to E1) 1. yes
D1.1. Occupational exposure to what hazardous substances (multiple choice)?
1. asbestos
2. radon, beryllium, chromium, cadmium, silicon
3. soot and soot ash
4. other, please specify

E. Family history of lung cancer

E1. Does your parent, child, or sibling (same parent) have lung cancer (definitively diagnosed by a formal health care provider)?      0. No 1. Yes

Signature of person completing:
Date filled in:Year_Month______Day

Appendix C
(informative)
Outcome management and follow-up

The management and follow-up protocols for baseline and annual screening results are given in Figures C.1 and C.2.

Figure C.1 Management and follow-up of baseline screening results
S (Solid nodule): solid nodule; PS (Part-solid nodule): partially solid nodule; NS (Non-solid nodule): non-solid nodule (pure ground glass density nodule)
: solid nodule or solid component of a partially solid nodule; #: positive means increased metabolism (radioactive uptake above the lung background); ☨: nodule enlargement means an increase in diameter of not less than 2.0 mm; ★: positive sputum cytology means suspicious malignant cells found in sputum, positive fiberoptic bronchoscopy means new organisms seen on bronchoscopy, mucosal abnormalities or sampling results suspicious or suggest tumor

Figure C.2 Annual screening results management and follow-up
: positive sputum cytology means suspicious malignant cells were found in sputum, positive fiberoptic bronchoscopy means new organisms, mucosal abnormalities or sampling results suspected or suggestive of tumor were seen on bronchoscopy; #: nodule enlargement means diameter line enlargement not less than 2.0 mm

A. Smoking status
A.	A1. Do you smoke (defined as smoking if you smoke more than one cigarette a day for more than 6 months continuously or cumulatively)? 0. no, never smoked (skip to B1) 1. yes, currently still smoking 2. used to smoke, now quit
A1.1.	A1.2. If you still smoke or have smoked, how many cigarettes per day (1 tael of tobacco ≈ 50 cigarettes)?
A1.3. If you still smoke or have smoked, how long have you smoked in total, minus the number of years you have quit smoking?
B1 A1.4.	B1 A1.4. If you currently quit smoking, how long has this quit lasted?
B.	B. Passive smoking status
B1. For nonsmokers, have you lived with a family member who smokes for more than 20 years? 0. no (skip to B2) 1. yes
B2. For non-smokers, has the family worked in the same room with a co-worker who smokes for more than 20 years? 0. No (skip to C1) 1. Yes

PrefacePreface

IntroductionIntroduction

5 Screening TechniquesLung cancer screening should be performed with low-dose spiral CT (LDCT) and should not be performed with chest x-ray.

6 Screening process (see Appendix A)

Appendix C(informative)Outcome management and follow-up

Appendix C
(informative)
Outcome management and follow-up