NCT06775015Not yet recruiting
SERS-Based Serum Molecular Spectral Detection of Invasive Lung Cancer
SERS-Based Serum Molecular Spectral Detection of Lung Cancer Microinvasion Versus Invasion Screening: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial
Source: ClinicalTrials.gov · Last updated 31 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Surgery is the main treatment for early lung cancer. It is worth noting that there are significant differences in postoperative prognosis and surgical methods between microinvasive cancer and early-stage invasive cancer. Micro invasive lung cancer can achieve 100% long-term survival through surgical resection, without the need for postoperative adjuvant radiotherapy. There is no need to remove lung lobes during surgery, only segmental or wedge resection is required, and systematic lymph node dissection is not recommended. Therefore, accurate prediction of preoperative and intraoperative microinvasive cancer and invasive cancer in pulmonary nodules is crucial for patients to choose surgical methods, which can significantly affect postoperative lung function retention and overall survival. Raman spectroscopy (RS), as a non-invasive and highly specific molecular detection technique, can be obtained at the molecular level to sensitively detect changes in biomolecules composed of proteins, nucleic acids, lipids, and sugars related to tumor metabolism in biological samples. The surface enhanced Raman spectroscopy (SERS) developed based on this technology is one of the feasible methods for high-sensitivity biomolecule analysis. We collected serum Raman spectroscopy data from a cohort of 138 early lung cancer patients in our preliminary research. Based on a machine learning model, we constructed an early lung microinvasive cancer and invasive cancer Raman intelligent diagnosis system, which achieved an accuracy rate of 89.4%. To obtain the highest level of clinical evidence and truly achieve clinical translation, this prospective, multicenter clinical study aims to validate the use of this intelligent diagnostic system for early diagnosis of lung cancer and the discrimination between microinvasive cancer and invasive cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 5 Jan 2025
- Start date
- 4 Apr 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fuzhou General Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06775015
What you commit to
- Study type: Observational
- Planned participants: 200
- From 4 Apr 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with concomitant other malignant tumors;
Other illness
- Participants with severe underlying lung diseases (such as bronchiectasis, bronchial asthma or COPD, etc.), or those with a history of occupational or environmental exposure to dust, mines or asbestos;
Other
- Participants with missing baseline clinical data;
- Participants who do not cooperate or refuse to participate in clinical trials at a later stage.
Who the study is looking for
- Participants confirmed by chest CT to have pulmonary nodules
- The diagnosis of participants with malignant pulmonary nodules must meet the TNM diagnostic criteria (Ninth Edition);
- Participants are willing to participate in this study and follow the research plan;
- Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The 900th Hospital of the Joint Logistic Support Force, PLA Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.