Clinical trial · Observational
Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics
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.
NCT07399210CI-TRIAL-00102916SHC2408recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fragmentomics | — | UNRESOLVED | — |
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| This study did not include intervention between two cohorts | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Training Cohort
- description
- 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.
- interventionNames
- Other: This study did not include intervention between two cohorts
- label
- Validation Cohort
- description
- 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.
- interventionNames
- Other: This study did not include intervention between two cohorts
Primary outcomes (1)
- measure
- Area under the receiver operating characteristic curve (AUC-ROC) for the cfDNA fragmentomics-based diagnostic model distinguishing malignant from benign lung nodules.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.