NCT04220268

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 5, 2020

Last Update Submit

January 5, 2020

Conditions

Keywords

Ground glass noduleFamily aggregationHereditary susceptibility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Susceptibility genetic events related to the family aggregation of ground glass nodules.

    1 month

Study Arms (1)

Participants

All the patients with proved malignant ground glass nodule will be enrolled.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients with pulmonary ground glass nodules and pathological proved malignant disease will be enrolled.

You may qualify if:

  • patients with informed consent;
  • patients with pulmonary ground glass nodule.
  • pathological proved early stage lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Related 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.

    PMID: 31326317BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and surgical tumor samples of all the participants will be collected. Moreover, blood samples of other family members of participants will be collected, with their consent and knowledge.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Wenzhao Zhong, Ph。D

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Porfessor

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

January 5, 2020

Primary Completion

January 5, 2022

Study Completion

January 31, 2022

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations