NCT07399210 Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
| NCT ID | NCT07399210 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baohui Han |
| Condition | Lung Cancer (Diagnosis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-08-21 |
| Primary Completion | 2026-08-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2024-08-21 with a primary completion date of 2026-08-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07399210 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07399210 currently recruiting?
Yes, NCT07399210 is actively recruiting participants. Contact the research team at dst.ding@gmail.com for enrollment information.
Where is the NCT07399210 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07399210 clinical trial?
NCT07399210 is sponsored by Baohui Han. The trial plans to enroll 240 participants.
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