Clinical trial · Observational
Monitoring the Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy.
Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy and Their Clinical Implications.
- 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)
In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. However, most of previous data were based on late stage tumor patients. This study plans to utilize the minimally invasive method to detect the changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs, autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Death or survival
- timeFrame
- Baseline and every three- or six-month follow-up within two years for each patient.
- description
- Death or survival
- measure
- Disease progress
- timeFrame
- Baseline and every three- or six-month follow-up within two years for each patient.
- description
- Complete Response(CR), Partial Response(PR), Stable Disease(SD), Progressive Disease(PD)
- measure
- Reasons of study termination
- timeFrame
- Baseline and every three- or six-month follow-up within two years for each patient.
- description
- Complete the study, Lost to follow-up, Withdrawal of informed consent, Terminated by the investigator, Severe adverse event(SAE).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed as suspected lung cancer patients with pulmonary nodules (single or multiple) by CT scans, and the maximum diameter of nodule is between 8mm and 3cm; * Male or female, with age of 18\~80 years; * Agree to take the pulmonary nodule biopsy, and sign the Informed Consent. Exclusion Criteria: * With severe comorbidities and unable to participate in this study; * Diagnosed with acute respiratory tract infection, for instance fungus, mycobacterium tuberculosis or other bacteria, virus, etc., one month prior to the study recruitment; * Pregnant or maternal women; * Diagnosed with other carcinoma, and the pulmonary nodules suspected of stemming from other sites; * Unable for regular follow-ups according to the research protocol; * Blood sample is not qualified for biomarker testing.
References
Publications (0)
Data not yet available