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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04220268
Other study ID # GGN-family
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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