Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation

Официальное название

Differentiating Benign and Malignant Pulmonary Nodules Using Epigenetically Modified Nucleosomes in Plasma

Обзор

Investigators aim to evaluate the diagnostic accuracy of the Nu.Q blood test for lung cancer in the Taiwanese population and compare its diagnostic performance with low-dose computed tomography (LDCT) or computed tomography (CT). Additionally, investigators will investigate the potential role of Nu.Q in lung cancer prevention and its impact on survival outcomes. Study Method: Investigators plan to collect 20 mL of blood samples from individuals undergoing chest LDCT/CT, isolate plasma for Nu.Q™ analysis, and compare the results with corresponding lung cancer pathology findings. The estimated sample size is 500 participants.

Подробное описание

Currently, early lung cancer screening primarily relies on low-dose computed tomography (LDCT) of the chest. However, blood tests offer a more convenient alternative. Despite this, existing blood tests lack sufficient accuracy and sensitivity for lung cancer screening. Developing a reliable blood-based screening tool could significantly enhance the detection rate and accuracy of early lung cancer screening.

Previous studies have shown that nucleosomes undergo variations during early cancer development. The Belgian company Volition has developed a blood test method based on chemiluminescence immunoassay (ChLIA) to measure nucleosomes in the blood, branded as Nu.Q™. Preliminary studies have demonstrated that Nu.Q™ can detect abnormal nucleosome biomarkers associated with early lung cancer.

This study, in collaboration with Volition, will collect 20 mL of blood samples from individuals undergoing chest LDCT. Plasma will be isolated and analyzed using Nu.Q™ at the National Taiwan University Center for Genomics and Precision Medicine. The test results will be compared with corresponding lung cancer medical records, LDCT findings, and pathological diagnoses. The study aims to enroll 500 participants.

The objectives of this study are to validate the diagnostic accuracy of the Nu.Q™ blood test for lung cancer in the Taiwanese population, compare its diagnostic performance with LDCT, and explore its potential role in lung cancer prevention and improved survival outcomes. This study is conducted as an industry-academic collaboration project with National Taiwan University.

Вмешательства

• Диагностический тест blood draw
  Plasma samples will be collected in NTU Hospital or NTUCC. ChLIA kits and all other reagents will be provided by Volition. ChLIA analysis of samples will be performed by a Volition designated laboratory in Taiwan( NTU Centres of Genomic and Precision Medicine).

Первичные конечные точки

• The endpoint is pathology result of diagnosis. [Срок оценки: 2 weeks]

Вторичные конечные точки (1)

• long-term cancer related outcomes [Срок оценки: 4 years]

Критерии участия

Критерии включения

• Aged 20 or older
• Underwent a low-dose chest CT scan or a standard chest CT scan, showing lung nodules ≥ 6mm
• Individuals understand the content of the consent form and are willing to participate in this study.
• The lung nodule is assessed by a physician as high-risk, requiring thoracic surgery or biopsy for diagnosis

Критерии исключения

• Pregnant women
• Individuals without capacity for consent, unable to understand the content of the consent form, or unwilling to participate in this study
• Assessed by a physician as unsuitable for thoracic surgery or biopsy for diagnosis

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• National Taiwan University — Taipei

Идентификаторы

NCT: NCT06838806 · 202412107RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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