A Prospective Cohort of Pulmonary Ground Glass Nodules Patients With Family History.

Lung Neoplasms Clinical Trial

— GGN-F  

Official title:

Clinical Database and Biobank of Pulmonary Ground Glass Nodules Patients With Family History, a Prospective Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04220268
• Other study ID #: GGN-family
• Status: Recruiting
• Start date: January 5, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2020
• Source: Guangdong Provincial People's Hospital
• Contact: Jia-Tao Zhang, Ph.D
• Phone: +86-83827812-51311
• Email: 18820792959[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the present prospective cohort study (GGN-F) is to study the family aggregation of pulmonary ground glass nodules via the questionnaire survey and to investigate the underlying genetic mechanism via the biobank.

Description:

In recent years, with the development of low-dose chest CT screening, more and more ground glass nodules have been found. Meanwhile, presenting as Ground-glass nodule (GGN), the early-stage lung adenocarcinoma patients with lung cancer family history have been emerging increasing in recent years in East Asian.

This prospective cohort study, with both a cross-sectional and a longitudinal part, will include patients with pulmonary ground glass nodule, which were proven malignant disease.

All participants will be asked to complete questionnaire to build the clinical database of GGN patients with detailed family history. Furthermore, blood and surgical tumor samples will be collected as a specific biobank. And the blood samples of other family members of participants will be collected, with their consent and knowledge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 31, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. patients with informed consent;

2. patients with pulmonary ground glass nodule.

3. pathological proved early stage lung cancer.

Exclusion Criteria:

1.not included in the inclusion criteria

Related Conditions & MeSH terms

• Family Research
• Lung Neoplasms

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Dai J, Lv J, Zhu M, Wang Y, Qin N, Ma H, He YQ, Zhang R, Tan W, Fan J, Wang T, Zheng H, Sun Q, Wang L, Huang M, Ge Z, Yu C, Guo Y, Wang TM, Wang J, Xu L, Wu W, Chen L, Bian Z, Walters R, Millwood IY, Li XZ, Wang X, Hung RJ, Christiani DC, Chen H, Wang M, Wang C, Jiang Y, Chen K, Chen Z, Jin G, Wu T, Lin D, Hu Z, Amos CI, Wu C, Wei Q, Jia WH, Li L, Shen H. Identification of risk loci and a polygenic risk score for lung cancer: a large-scale prospective cohort study in Chinese populations. Lancet Respir Med. 2019 Oct;7(10):881-891. doi: 10.1016/S2213-2600(19)30144-4. Epub 2019 Jul 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of family aggregation of pulmonary ground glass nodule.	To investigate the aggregation of pulmonary ground glass nodule among first-degree relatives of participants via the questionnaire.	1 week
Secondary	Susceptibility genetic events related to the family aggregation of ground glass nodules.	To investigate the underlying susceptibility genetic loci which concern with familial inheritance of ground glass nodule.	1 month