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Clinical Trial NCT06772363 for Lung Cancers is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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SERS-Based Serum Molecular Spectral Screening for Hematogenous Metastasis 200 Non-Invasive Real-World Evidence Translation Available

Not yet recruiting
Clinical Trial NCT06772363 is an observational study for Lung Cancers and is currently not yet recruiting. Enrollment is planned to begin on 9 April 2026 and continue until the study accrues 200 participants. Led by Fuzhou General Hospital, this study is expected to complete by 1 June 2026. The latest data from ClinicalTrials.gov was last updated on 31 March 2025.
Brief Summary
Although modern medicine has made significant progress in the diagnosis and treatment of lung cancer, most patients are diagnosed at locally advanced stage or with distant metastases, especially in the late stages where the cancer has spread to other organs through hematogenous metastasis. This not only significantly the survival rate of patients but also increases the complexity and difficulty of treatment. Hematoge...Show More
Detailed Description
This study used a confocal Raman microspectrometer produced by Renishaw, Britain, purchased by the Key Laboratory of the School of Optoelectronics and Engineering of Fujian Normal University. The spectral resolution was 2 cm-1, the excitation wavelength was 785 nm, and a 20x objective Leica microscope was used to collect SERS spectra in the range of 400-1800 cm-1. The excitation irradiation time of each spectrum was ...Show More
Official Title

SERS-Based Serum Molecular Spectral Screening for Hematogenous Metastasis vs. Non-Metastasis in Non-Small Cell Lung Cancer: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial

Conditions
Lung Cancers
Other Study IDs
  • 2024-044
NCT ID Number
NCT06772363
Start Date (Actual)
2026-04-09
Last Update Posted
2025-03-31
Completion Date (Estimated)
2026-06-01
Enrollment (Estimated)
200
Study Type
Observational
Status
Not yet recruiting
Keywords
SERS
NSCLC
Raman
diagnostic model
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Patients who underwent chest CT scans and were found to have lung nodules
Patients who underwent chest CT scans and were found to have lung nodules and underwent surgical resection
Serum Raman spectroscopy intelligent diagnostic system
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 compl...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Diagnostic accuracy
Determine whether there is hematogenous metastasis in enrolled lung cancer patients through RAMAN intelligent diagnostic system
through study completion, an average of 1 year
Time to RAMAN diagnosis
The time to perform RAMAN testing and obtain diagnostic results after obtaining serum
up to 30 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Safety assessment Results
AEs and SAEs through Day 30
up to 30 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Participants with Lung cancer meeting the criteria of TNM (Ninth Edition);
  2. Participants are willing to participate in this study and follow the research plan;
  3. Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;

  1. Participants with concomitant other malignant tumors;
  2. Participants with missing baseline clinical data;
  3. 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;
  4. Participants who do not cooperate or refuse to participate in clinical trials at a later stage.
Fuzhou General Hospital logoFuzhou General Hospital
Study Central Contact
Contact: Zongyang Yu, Ph.D, 13509327806, [email protected]
1 Study Locations in 1 Countries

Fujian

Raman detector, Fuzhou, Fujian, China
Zongyang Yu, Ph.D, Contact, [email protected]