Pulmonary Nodules, SolitaryNCT06187935
Early Adjuvant Diagnosis of Pulmonary Nodules Based on CTC.
An observational study of Pulmonary Nodules, Solitary and Pulmonary Nodules, Multiple, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of this observational clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. The main questions it aims to answer is: the sensitivity and specificity of peripheral blood circulating tumor cell detection in differentiating benign and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodules, Solitary, Pulmonary Nodules, Multiple
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary nodules no more than 3cm on CT imaging that are clinically suspected to be malignant and scheduled for surgery or biopsy.
Who may be able to join
- 1. Patients with single or multiple pulmonary nodules on CT imaging; 2. Subjects ≥18 years old, regardless of gender, occupation, and region, should have independent capacity for civil conduct and sign the informed consent for clinical study; 3. Subjects are generally in good condition, with ECOG score 0-1 and life expectancy of no less than 2 months; 4. Organ function level requirements:
- Peripheral blood: 1.5 x 10^9/L≤ absolute neutrophil count (ANC) ≤15 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9.0 g/dL; Prothrombin time (PT) ≥11 seconds, International normalized ratio (INR) ≥0.8;
- Bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
- Serum creatinine ≤1.5 times the upper limit of normal value.
Who cannot join
- 1. The subjects had a history of malignant tumors, or serious cardiovascular and cerebrovascular diseases (had undergone heart stent surgery within 6 months or had been admitted to ICU, CCU or other intensive care units due to cardiovascular and cerebrovascular diseases, or EF≤50%); b. Severe vasculopathy, pulmonary tuberculosis or large-scale acute inflammation (including but not limited to acute bronchitis, vasculitis, etc.) or active chronic infection (HIV, HBV, HCV, etc.) within 3 months; 3. Poor compliance, unable to cooperate with the research program; 4. Participants in any drug trial within three months prior to enrollment; 5. Pregnant or breastfeeding; 6. Puncture/Surgical contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Early Adjuvant Diagnosis Clinical Trial of Pulmonary Nodules Based on Circulating Tumor Cells.
The goal of this observational clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. The main questions it aims to answer is: the sensitivity and specificity of peripheral blood circulating tumor cell detection in differentiating benign and malignant pulmonary nodules (≤3cm). Participants will be asked provide 4mL of peripheral blood for the test.
Read the detailed description
The aim of this clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. Peripheral blood of participants will be collected before surgery or biopsy. Clinical and imaging data of enrolled patients will also be collected. Pathological diagnosis is the gold standard for differentiating benign and malignant pulmonary nodules. The sensitivity and specificity of CTC detection for diagnosing malignant pulmonary nodules will be analyzed.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary nodule group | Patients with pulmonary nodules no more than 3cm on CT imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
the ability of peripheral blood CTC count detection to identify malignant pulmonary nodules when the real condition is malignancy
Measured: until the samples are collected and tested as planned, up to 72 months
specificity
the ability of peripheral blood CTC count detection to exclude malignant pulmonary nodules when the real condition is benign disease
Measured: until the samples are collected and tested as planned, up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jan 2019
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodules, SolitaryStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangying Zhu, China-Japan Friendship Hospital
- Investigators
- Guangying Zhu, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187935
- Sponsor's protocol ID
- 2018-170-K124
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Original research data including study protocol and statistical analysis plan will be shared after the study is completed and the research results are published.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Adjuvant Diagnosis Clinical Trial of Pulmonary Nodules Based on Circulating Tumor Cells.
- ClinicalTrials.gov ID
- NCT06187935
- Acronym / sponsor ID
- 2018-170-K124
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 3 Jan 2024 (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 goal of this observational clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. The main questions it aims to answer is: the sensitivity and specificity of peripheral blood circulating tumor cell detection in differentiating benign and malignant pulmonary nodules (≤3cm). Participants will be asked provide 4mL of peripheral blood for the test.
Detailed description
The aim of this clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. Peripheral blood of participants will be collected before surgery or biopsy. Clinical and imaging data of enrolled patients will also be collected. Pathological diagnosis is the gold standard for differentiating benign and malignant pulmonary nodules. The sensitivity and specificity of CTC detection for diagnosing malignant pulmonary nodules will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary nodule group | – | –Patients with pulmonary nodules no more than 3cm on CT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary nodules no more than 3cm on CT imaging that are clinically suspected to be malignant and scheduled for surgery or biopsy.
Key inclusion criteria (4 listed)
- 1. Patients with single or multiple pulmonary nodules on CT imaging; 2. Subjects ≥18 years old, regardless of gender, occupation, and region, should have independent capacity for civil conduct and sign the informed consent for clinical study; 3. Subjects are generally in good condition, with ECOG score 0-1 and life expectancy of no less than 2 months; 4. Organ function level requirements:
- Peripheral blood: 1.5 x 10^9/L≤ absolute neutrophil count (ANC) ≤15 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9.0 g/dL; Prothrombin time (PT) ≥11 seconds, International normalized ratio (INR) ≥0.8;
- Bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
- Serum creatinine ≤1.5 times the upper limit of normal value.
Key exclusion criteria (1 listed)
- 1. The subjects had a history of malignant tumors, or serious cardiovascular and cerebrovascular diseases (had undergone heart stent surgery within 6 months or had been admitted to ICU, CCU or other intensive care units due to cardiovascular and cerebrovascular diseases, or EF≤50%); b. Severe vasculopathy, pulmonary tuberculosis or large-scale acute inflammation (including but not limited to acute bronchitis, vasculitis, etc.) or active chronic infection (HIV, HBV, HCV, etc.) within 3 months; 3. Poor compliance, unable to cooperate with the research program; 4. Participants in any drug trial within three months prior to enrollment; 5. Pregnant or breastfeeding; 6. Puncture/Surgical contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitivity
Time frame: until the samples are collected and tested as planned, up to 72 months
the ability of peripheral blood CTC count detection to identify malignant pulmonary nodules when the real condition is malignancy
specificity
Time frame: until the samples are collected and tested as planned, up to 72 months
the ability of peripheral blood CTC count detection to exclude malignant pulmonary nodules when the real condition is benign disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Yes. Original research data including study protocol and statistical analysis plan will be shared after the study is completed and the research results are published.
Related trials for Pulmonary Nodules, Solitary
RecruitingObservational study
Biomarkers for Risk Stratification in Lung Cancer
Nodule Solitary Pulmonary, Non-small Cell Lung Cancer
RecruitingObservational study
European Real-World Registry for Use of the Ion Endoluminal System
Pulmonary Nodule, Lung Cancer
Recruiting
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules
Not yet recruitingObservational study
Radiomics for Distinguishing Benign and Malignant Lung Nodules
Solitary Pulmonary Nodule, Lung Neoplasms
Active, not recruiting
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
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.
Guangying Zhu, M.D. principal investigator
China-Japan Friendship Hospital
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 Nodules, Solitary and Pulmonary Nodules, Multiple, run by China-Japan Friendship Hospital 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sensitivity (time frame: until the samples are collected and tested as planned, up to 72 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?
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 27 Feb 2025.