Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005677
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Yang Jin, Wuhan Union Hospital, China

Brief Summary:
The researchers are aimed to investigate the early diagnosis of pulmonary nodule based on DNA, RNA, protein, metabolites through analyzing the serum, urine and clinical characteristics.

Condition or disease Intervention/treatment
Pulmonary Nodule, Solitary Lung; Node Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status

Detailed Description:
By recruiting people with pulmonary nodules identified by CT scans, three groups are confirmed as the lung cancer group, the benign lung nodule group who are identified by pathological analysis, and the small lung nodule group that should be followed up. Then the serum, the urine and the clinical characteristics including age, sex, smoking status, BMI, address, greening environment are collected to analyze the ctDNA, RNA, protein, metabolites, immune status and their relationships with the tumorigenesis and the gene mutation of lung cancer.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
lung cancer Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status

benign lung nodule Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status

lung nodule Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status




Primary Outcome Measures :
  1. Up-regulation of ctDNA [ Time Frame: the first day subjects are enrolled the outcome will be assessed ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects enrolled are volenteered and are willing to be followed up.
Criteria

Inclusion Criteria:

For lung cancer groups

  • (1) Patients diagnosed with lung cancer;
  • (2) Clear diagnosis by pathological examination to determine pathological type;
  • (3) Those aged 18-80 years old;
  • (4) For patients with newly diagnosed lung cancer, CT confirmed that the size of primary lung cancer is ≤ 3 cm;
  • (5) The patient or family member agrees to participate in the study and sign an informed consent form;
  • (6) No other serious cardiopulmonary diseases. For lung nodule
  • (1) Those aged 18-80 years;
  • (2) CT clear lung nodule size ≤ 3cm;
  • (3) 1-3cm pulmonary nodules confirmed by pathological diagnosis as non-lung cancer or other metastatic cancer patients or ≤1cm pulmonary nodules
  • (4) The patient or family member agrees to participate in the study and sign an informed consent form;
  • (5) No other serious cardiopulmonary diseases.

Exclusion Criteria:

  • (1) Women who are breast-feeding, pregnant or preparing for pregnancy;
  • (2) Those who are allergic to allergies and multiple drugs;
  • (3) Combining severe primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematopoietic system, as well as subjects with mental illness;
  • (4) concurrently infected;
  • (5) Those who participated in other clinical trials within three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005677


Contacts
Layout table for location contacts
Contact: jinshuo fan +8615827367482 whxhfjs@hust.edu.cn

Locations
Layout table for location information
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430000
Contact: Yang Jin, MD         
Sponsors and Collaborators
Wuhan Union Hospital, China
Layout table for additonal information
Responsible Party: Yang Jin, Professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04005677    
Other Study ID Numbers: Whuh2019 v.1
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases