A Prospective Cohort of Pulmonary Ground Glass Nodules Patients With Family History. (GGN-F)

January 5, 2020 updated by: Wen-zhao ZHONG, Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants
All the patients with proved malignant ground glass nodule will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of family aggregation of pulmonary ground glass nodule.
Time Frame: 1 week
To investigate the aggregation of pulmonary ground glass nodule among first-degree relatives of participants via the questionnaire.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Susceptibility genetic events related to the family aggregation of ground glass nodules.
Time Frame: 1 month
To investigate the underlying susceptibility genetic loci which concern with familial inheritance of ground glass nodule.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Wenzhao Zhong, Ph。D, Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2020

Primary Completion (Anticipated)

January 5, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

January 5, 2020

First Submitted That Met QC Criteria

January 5, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 5, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGN-family

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe