Lung Cancer
Conditions
Keywords
Pulmonary Nodule; Lung Cancer; Biopsy; Biomarker.
Brief summary
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.
Interventions
None listed
Sponsors
China-Japan Friendship Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death or survival | Baseline and every three- or six-month follow-up within two years for each patient. | Death or survival |
| Disease progress | Baseline and every three- or six-month follow-up within two years for each patient. | Complete Response(CR), Partial Response(PR), Stable Disease(SD), Progressive Disease(PD) |
| Reasons of study termination | Baseline and every three- or six-month follow-up within two years for each patient. | Complete the study, Lost to follow-up, Withdrawal of informed consent, Terminated by the investigator, Severe adverse event(SAE). |
Countries
China
Contacts
Primary ContactJieping LEI, Ph.D.
Backup ContactSinan WU, M.D.
Outcome results
None listed