Lung Cancer (Diagnosis)SHC2408NCT07399210
Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
An observational study of Lung Cancer (Diagnosis) and Fragmentomics, run by Baohui Han at 1 site in China.
Trial summary
The goal of this observational study is to learn if cfDNA fragmentomics can noninvasively diagnose whether lung nodules are benign or malignant in adults with imaging-detected lung nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Fragmentomics
- What is being tested?
- This study did not include intervention between two cohorts
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to 21 Aug 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This study will enroll adults (≥18 years old) with CT-detected pulmonary nodules of specified types and sizes, who are willing to undergo diagnostic confirmation and provide a peripheral blood sample prior to treatment. Participants must not have received cancer therapy within the last 3 months.
Who may be able to join
- Age ≥ 18 years;
- Positive for lung nodules on low-dose spiral CT (LDCT) meeting one of the following criteria:
- Solid or part-solid nodules ≥ 5 mm and ≤ 20 mm; Pure ground-glass nodules ≥ 8 mm and ≤ 30 mm; In cases of multiple nodules, the largest nodule (by maximum diameter) must meet these criteria;
- Participants whose lung nodule status (benign or malignant) can be clinically confirmed;
- No cancer-directed therapy (e.g., chemotherapy, radiotherapy, immunotherapy, cell therapy) within the past 3 months;
- Able to provide a 5 mL peripheral blood sample prior to any treatment;
- Voluntary signing of informed consent after full explanation of the study.
Who cannot join
- Pregnant or breastfeeding;
- Current or past diagnosis (within the past 5 years) of malignant tumors (excluding patients with early-stage lung cancer who have undergone surgery but still have multiple evaluable nodules), or with severe heart disease, serious liver or kidney disorders, or significant bone marrow hematopoietic dysfunction;
- History of organ transplantation or blood transfusion within the past 3 months;
- History of seropositivity for human immunodeficiency virus (HIV);
- Any other condition deemed inappropriate for study participation by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Wang, +8613524594847, dst.ding@gmail.com
About this study
Official title: A Prospective Clinical Study Evaluating the Noninvasive Use of Circulating Cell-Free DNA Fragmentomics to Differentiate Benign and Malignant Lung Nodules, With Emphasis on Small Nodules.
The goal of this observational study is to learn if cfDNA fragmentomics can noninvasively diagnose whether lung nodules are benign or malignant in adults with imaging-detected lung nodules.
- Conditions
- Lung Cancer (Diagnosis), Fragmentomics
- Being tested
- This study did not include intervention between two cohorts
- Keywords
- Fragmentomics, Lung Cancer(Diagnosis), cfDNA, Small Nodule, Non-invasive
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study did not include intervention between two cohortsOther
This study did not include intervention between two cohorts
| Study group | Role | What they receive |
|---|---|---|
| Training Cohort | A group of 160 adults with imaging-detected lung nodules who will each provide a blood sample for cfDNA fragmentomics analysis. Data from this cohort will be used to train the diagnostic algorithm, teaching it to recognize the cfDNA patterns that distinguish benign from malignant nodules. Receives: Other: This study did not include intervention between two cohorts | |
| Validation Cohort | An independent set of 80 adults with similar imaging-detected lung nodules. These participants will undergo the same blood sampling and cfDNA analysis, and their confirmed diagnoses (benign or malignant) will be used to evaluate the algorithm's performance-measuring sensitivity, specificity, accuracy, and area under the ROC curve. Receives: Other: This study did not include intervention between two cohorts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic curve (AUC-ROC) for the cfDNA fragmentomics-based diagnostic model distinguishing malignant from benign lung nodules.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start21 Aug 2024
- Primary completion21 Aug 2026 (estimated)
- Study completion21 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies 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
- 240 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Baohui Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baohui Han, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399210
- Sponsor's protocol ID
- ShanghaiChest2408
- Acronym
- SHC2408
- Status last verified
- Feb 2026
- First submitted
- 10 Aug 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study Evaluating the Noninvasive Use of Circulating Cell-Free DNA Fragmentomics to Differentiate Benign and Malignant Lung Nodules, With Emphasis on Small Nodules.
- ClinicalTrials.gov ID
- NCT07399210
- Acronym / sponsor ID
- SHC2408 / ShanghaiChest2408
- Conditions
- Lung Cancer (Diagnosis), Fragmentomics
- Keywords
- Fragmentomics, Lung Cancer(Diagnosis), cfDNA, Small Nodule, Non-invasive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Baohui HanUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 21 Aug 2026 (estimated)
- Study completion
- 21 Aug 2026 (estimated)
- First posted
- 10 Feb 2026 (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 study is to learn if cfDNA fragmentomics can noninvasively diagnose whether lung nodules are benign or malignant in adults with imaging-detected lung nodules.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Cohort | – | Other: This study did not include intervention between two cohortsA group of 160 adults with imaging-detected lung nodules who will each provide a blood sample for cfDNA fragmentomics analysis. Data from this cohort will be used to train the diagnostic algorithm, teaching it to recognize the cfDNA patterns that distinguish benign from malignant nodules. |
| Validation Cohort | – | Other: This study did not include intervention between two cohortsAn independent set of 80 adults with similar imaging-detected lung nodules. These participants will undergo the same blood sampling and cfDNA analysis, and their confirmed diagnoses (benign or malignant) will be used to evaluate the algorithm's performance-measuring sensitivity, specificity, accuracy, and area under the ROC curve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll adults (≥18 years old) with CT-detected pulmonary nodules of specified types and sizes, who are willing to undergo diagnostic confirmation and provide a peripheral blood sample prior to treatment. Participants must not have received cancer therapy within the last 3 months.
Key inclusion criteria (7 listed)
- Age ≥ 18 years;
- Positive for lung nodules on low-dose spiral CT (LDCT) meeting one of the following criteria:
- Solid or part-solid nodules ≥ 5 mm and ≤ 20 mm; Pure ground-glass nodules ≥ 8 mm and ≤ 30 mm; In cases of multiple nodules, the largest nodule (by maximum diameter) must meet these criteria;
- Participants whose lung nodule status (benign or malignant) can be clinically confirmed;
- No cancer-directed therapy (e.g., chemotherapy, radiotherapy, immunotherapy, cell therapy) within the past 3 months;
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding;
- Current or past diagnosis (within the past 5 years) of malignant tumors (excluding patients with early-stage lung cancer who have undergone surgery but still have multiple evaluable nodules), or with severe heart disease, serious liver or kidney disorders, or significant bone marrow hematopoietic dysfunction;
- History of organ transplantation or blood transfusion within the past 3 months;
- History of seropositivity for human immunodeficiency virus (HIV);
- Any other condition deemed inappropriate for study participation by the investigators.
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 |
|---|---|---|
| This study did not include intervention between two cohortsThis study did not include intervention between two cohorts | Other | Training Cohort, Validation Cohort |
Primary outcome
Area under the receiver operating characteristic curve (AUC-ROC) for the cfDNA fragmentomics-based diagnostic model distinguishing malignant from benign lung nodules.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Lung Cancer (Diagnosis) and Fragmentomics, run by Baohui Han 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuan Wang (+8613524594847, dst.ding@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic curve (AUC-ROC) for the cfDNA fragmentomics-based diagnostic model distinguishing malignant from benign lung nodules. (time frame: 1 year). 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 10 Feb 2026.