Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making (DEPICT)

March 15, 2023 updated by: GuiBin Qiao

Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making: A Prospective Cohort Study

The researchers are aimed to investigate the dynamic evolution of indeterminate pulmonary nodules by a long-term follow-up of patients with different characteristics. Influence factors of clinical decision-making that might contribute to overtreatment or delayed treatment will also be studied.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This observatory study prospectively recruits patients with indeterminate pulmonary nodules identified in computed tomography (CT) scans from thoracic clinic. The radiological features and their chronological changes during follow-up period will be recorded in detail. Subgroup analyses will be performed based on the clinical and demographic characteristics of patients (including symptomatic information, comorbidities, family history, antibiotic usage, etc). Hospital Anxiety and Depression Scale (HADS) is collected from each patient at multiple time points to evaluate the patients' psychological status and its impact on clinical decision-making. The interaction analyses between individual characteristics (such as education level, occupation, disease cognitive level, etc) and Hospital Anxiety and Depression Scale will also be performed. The researchers aim to provide high-quality evidence for the formulation of a precise follow-up and management plan for patients with pulmonary nodules.

Study Type

Observational

Enrollment (Actual)

1800

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital

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

14 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All participants in this study are diagnosed with solitory or multiple indeterminate pulmonary nodules( ≤ 3cm ), and are willing to be followed-up for continous collection of their related disease information.

Description

Inclusion Criteria:

  1. Patients with pulmonary nodules ≤ 3cm
  2. Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort

Exclusion Criteria:

  1. Patients with a surgical history of pulmonary nodules;
  2. Patients who have obtained pathological diagnosis through surgery or non-surgical methods such as puncture;
  3. Patients with pulmonary nodules that are likely metastatic from other sites;
  4. Refuse to participate in this study.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulmonary Nodule
Patients are recommended for using antibiotics, solely follow-up or surgical resection according to the current clinical guideline for management of indeterminate pulmonary nodule. No intervention is administered for this observatory study.
Diagnostic test: CT scan
For patients with low-risk pulmonary nodules, follow-up CT scan is recommended
Drug: Antibiotics
For pulmonary nodules with features of infectious disease, antibiotics is recommended
Procedure: Surgical Resection
For persistent high-risk pulmonary nodules, surgical resection is recommended

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to surgical resection
Time Frame: The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months
Time calculated from the date of identification of pulmonary nodule to the date of surgical resection
The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months
Time to progression
Time Frame: The date of first documented diagnosis of pulmonary nodule by CT scan to the date of documented progression by CT scan, up to 60 months
Time calculated from the date of identification of pulmonary nodule to the date of progression of pulmonary nodule based on evaluation of CT imaging
The date of first documented diagnosis of pulmonary nodule by CT scan to the date of documented progression by CT scan, up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of malignancy
Time Frame: The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months
Proportion of malignant findings by pathological examination in all patients receiving surgical resection
The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months
Change of Hospital Anxiety and Depression Scale-Anxiety (HADS-A) score
Time Frame: The date of enrollment in our cohort study when Hospital Anxiety and Depression Scale is measured to the date when primary endpoint( surgical resection) is reached, up to 60 months, with multiple measurements.
The differences of Hospital Anxiety and Depression Scale-Anxiety (HADS-A) scores of the same patients before and after surgical resection. This 7-item checklist is a part of the Hospital Anxiety and Depression Scale, which is used for assessment for the status of anxiety. The maximal score for HADS-A is 21. Scores of greater than or equal to 11 on either scale indicate a definitive case. Scores of 0-7 are defined to be normal, while scores of 8-10 are defined to be borderline abnormal (borderline case).
The date of enrollment in our cohort study when Hospital Anxiety and Depression Scale is measured to the date when primary endpoint( surgical resection) is reached, up to 60 months, with multiple measurements.
Change of Hospital Anxiety and Depression Scale-Depression (HADS-D) score
Time Frame: The date of enrollment in our cohort study when Hospital Anxiety and Depression Scale is measured to the date when primary endpoint( surgical resection) is reached, up to 60 months, with multiple measurements.
The differences of Hospital Anxiety and Depression Scale-Depression (HADS-D) scores of the same patients before and after surgical resection. This 7-item checklist is a part of the Hospital Anxiety and Depression Scale, which is used for assessment for the status of depression. The maximal score for HADS-D is 21. Scores of greater than or equal to 11 on either scale indicate a definitive case. Scores of 0-7 are defined to be normal, while scores of 8-10 are defined to be borderline abnormal (borderline case).
The date of enrollment in our cohort study when Hospital Anxiety and Depression Scale is measured to the date when primary endpoint( surgical resection) is reached, up to 60 months, with multiple measurements.

Collaborators and Investigators

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

Sponsor

GuiBin Qiao

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 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-Q-2021-005-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All individual participant data are strictly protected for patient privacy according to the agreement in Informed Consent Form.

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.

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