Pulmonary Nodule, SolitaryDEPICTNCT04857333
Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making
An observational study of Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, run by GuiBin Qiao at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
- What is being tested?
- CT scan, Antibiotics and Surgical Resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with pulmonary nodules ≤ 3cm
- Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort
Who cannot join
- Patients with a surgical history of pulmonary nodules;
- Patients who have obtained pathological diagnosis through surgery or non-surgical methods such as puncture;
- Patients with pulmonary nodules that are likely metastatic from other sites;
- Refuse to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- CT scan, Antibiotics, Surgical Resection
- Keywords
- Pulmonary nodule, Radiologic picture, Prospective observatory study, Psychological state, Decision-making
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
For patients with low-risk pulmonary nodules, follow-up CT scan is recommended
AntibioticsDrug
For pulmonary nodules with features of infectious disease, antibiotics is recommended
Surgical ResectionProcedure or surgery
For persistent high-risk pulmonary nodules, surgical resection is recommended
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CT scan; Drug: Antibiotics; Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to surgical resection
Time calculated from the date of identification of pulmonary nodule to the date of surgical resection
Measured: 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 calculated from the date of identification of pulmonary nodule to the date of progression of pulmonary nodule based on evaluation of CT imaging
Measured: 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 outcomes (3)
Proportion of malignancy
Proportion of malignant findings by pathological examination in all patients receiving surgical resection
Measured: 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
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).
Measured: 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
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- GuiBin Qiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, GuiBin Qiao, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857333
- Sponsor's protocol ID
- KY-Q-2021-005-03
- Acronym
- DEPICT
- Status last verified
- Mar 2023
- First submitted
- 19 Apr 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All individual participant data are strictly protected for patient privacy according to the agreement in Informed Consent Form.
Publications
Wu J, Zhuang W, Chen R, Xu H, Li Z, Lan Z, Xia X, He Z, Li S, Deng C, Xu W, Shi Q, Tang Y, Qiao G. Impact of surgery versus follow-up on psychological distress in patients with indeterminate pulmonary nodules: A prospective observational study. Qual Life Res. 2025 Apr;34(4):1167-1177. doi: 10.1007/s11136-024-03876-w. Epub 2025 Jan 15.
PubMed 39812961Zhuang W, Tang Y, Xu W, Huang S, Deng C, Chen R, Zhang D, Zeng C, Tian D, Ben X, Lan Z, Wu H, Gao Z, Wang M, Chen Y, Shi Q, Qiao G. Should psychological distress be listed as a surgical indication for indeterminate pulmonary nodules: protocol for a prospective cohort study in real-world settings. J Thorac Dis. 2022 Mar;14(3):769-778. doi: 10.21037/jtd-21-1423.
PubMed 35399240
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04857333
- Acronym / sponsor ID
- DEPICT / KY-Q-2021-005-03
- Keywords
- Pulmonary nodule, Radiologic picture, Prospective observatory study, Psychological state, Decision-making
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- GuiBin QiaoUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Nodule | – | Diagnostic Test: CT scan, Drug: Antibiotics, Procedure: Surgical ResectionPatients 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. |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with pulmonary nodules ≤ 3cm
- Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort
Key exclusion criteria (4 listed)
- Patients with a surgical history of pulmonary nodules;
- Patients who have obtained pathological diagnosis through surgery or non-surgical methods such as puncture;
- Patients with pulmonary nodules that are likely metastatic from other sites;
- Refuse to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanFor patients with low-risk pulmonary nodules, follow-up CT scan is recommended | Diagnostic test | Pulmonary Nodule |
| AntibioticsFor pulmonary nodules with features of infectious disease, antibiotics is recommended | Drug | Pulmonary Nodule |
| Surgical ResectionFor persistent high-risk pulmonary nodules, surgical resection is recommended | Procedure or surgery | Pulmonary Nodule |
Primary outcome
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
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
3 secondary outcomes
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 39812961Wu J, Zhuang W, Chen R, Xu H, Li Z, Lan Z, Xia X, He Z, Li S, Deng C, Xu W, Shi Q, Tang Y, Qiao G. Impact of surgery versus follow-up on psychological distress in patients with indeterminate pulmonary nodules: A prospective observational study. Qual Life Res. 2025 Apr;34(4):1167-1177. doi: 10.1007/s11136-024-03876-w. Epub 2025 Jan 15.
- Derived from this study: PubMed 35399240Zhuang W, Tang Y, Xu W, Huang S, Deng C, Chen R, Zhang D, Zeng C, Tian D, Ben X, Lan Z, Wu H, Gao Z, Wang M, Chen Y, Shi Q, Qiao G. Should psychological distress be listed as a surgical indication for indeterminate pulmonary nodules: protocol for a prospective cohort study in real-world settings. J Thorac Dis. 2022 Mar;14(3):769-778. doi: 10.21037/jtd-21-1423.
- Individual participant dataSharing planned: No. All individual participant data are strictly protected for patient privacy according to the agreement in Informed Consent Form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, run by GuiBin Qiao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04857333, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.