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NCT Number: NCT06775015

SERS-Based Serum Molecular Spectral Detection of Invasive Lung Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The 900th Hospital of the Joint Logistic Support Force, PLA

Fuzhou, Fujian, 350025, China

Location contact

Zongyang Yu, Ph.D

CONTACT

[email protected]

13509327806

About this study

  • Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
  • The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
  • Completion of baseline procedures, participants were assessed for 30 days and completed all safety monitoring.
  • After completing the baseline assessment and confirming enrollment, participants will be given 2ml of fasting venous blood.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • Participants with concomitant other malignant tumors;
  • Participants with missing baseline clinical data;
  • 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;
  • Participants who do not cooperate or refuse to participate in clinical trials at a later stage.

Treatment and study plan

Serum Raman spectroscopy intelligent diagnostic system

Diagnostic Test

Serum Raman spectroscopy intelligent diagnostic system Description: 1. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. The following is the general sequence of events during the 3 months evaluation period: 4. Completion of baseline procedures Participants were assessed for 3 months and completed all safety monitoring.

Primary outcomes

  1. Diagnostic accuracy

    Time frame: through study completion, an average of 1 year

    Determine whether there is hematogenous metastasis in enrolled lung cancer patients through RAMAN intelligent diagnostic system

  2. Time to RAMAN diagnosis

    Time frame: up to 30 days

    The time to perform RAMAN testing and obtain diagnostic results after obtaining serum

Secondary outcomes

  1. Safety assessment Results

    Time frame: up to 30 days

    AEs and SAEs through Day 30

Study contacts

Contact information is provided by the study sponsor or research team.

Zongyang Yu, Ph.D

CONTACT

[email protected]

13509327806

Sponsors and collaborators

Lead sponsor

Fuzhou General Hospital

Other

Registry information

Official study title

SERS-Based Serum Molecular Spectral Detection of Lung Cancer Microinvasion Versus Invasion Screening: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Mar 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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