SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type

Официальное название

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

Обзор

Lung cancer can be divided into two major categories: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC accounting for about 85% and SCLC about 15%. The prognoses of different types of lung cancer vary significantly. Early identification of different pathological types of lung cancer is crucial to the patient's prognosis. Raman Spectrum (RS), as a non-invasive and highly specific molecular detection technique, can obtain information at the molecular level, thereby sensitively detecting changes in biomolecules related to tumor metabolism such as proteins, nucleic acids, lipids, and sugars. Surface-enhanced Raman spectroscopy (SERS), developed based on this technology, is one of the feasible methods for high-sensitivity biomolecular analysis. In preliminary study, the investigators collected serum Raman spectral data from a cohort of 233 patients with malignant lung tumors and built a Raman intelligent diagnostic system for SCLC and NSCLC based on a machine learning model, achieving an accuracy rate of 80%. 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 the early diagnosis of SCLC.

Подробное описание

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. Completion of baseline procedures, participants were assessed for 30 days and completed all safety monitoring. 4. After completing the baseline assessment and confirming enrollment, participants will be given 2ml of fasting venous blood.

Вмешательства

• Диагностический тест 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 completed all safety monitoring.

Первичные конечные точки

• pathology [Срок оценки: through study completion, an average of 1 year]
• Diagnostic accuracy [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (2)

• Time to RAMAN diagnosis [Срок оценки: up to 30 days]
• Safety assessment Results [Срок оценки: up to 30 days]

Критерии участия

Критерии включения

• Participants with Lung cancer meeting the criteria of TNM (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;.

Критерии исключения

• Participants with concomitant other malignant tumors;
• Participants with missing baseline clinical data;
• Participants with severe underlying pulmonary diseases (such as bronchiectasis, bronchial asthma, or COPD), or those with a history of occupational or environmental exposure to dust, mines, or asbestos;
• Participants who are uncooperative or refuse to participate in the clinical trial later on.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06775002 · 2024-042

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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