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The Red Blood Cells Based Blood Test for Lung Cancer EARLY Detection

NCT05380999 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 852

Last updated 2022-05-19

No results posted yet for this study

Summary

This study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. The DNA 5-methylcytosine(5-mC) and RNA 2'-O-methylation information will be acquired by NGS and Nm Judge Universally sequencing (NJU-Seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. The pathological results will be acquired after surgery or biopsy as standard in the study.

Conditions

Interventions

DIAGNOSTIC_TEST

Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)

Up to 15 ml of peripheral blood will be collected from each subject, and the blood specimen will be processed to isolate mature red blood cells and extract the DNA and RNA from RBCs. DNA and RNA methylation will be tested by next-generation sequencing (NGS).

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Shanghai Chest Hospital

    collaborator OTHER

  • Guangzhou Panyu Central Hospital

    collaborator OTHER

  • My-BioMed Technology （Guangzhou） Co., Ltd.

    collaborator UNKNOWN

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Tao Wang, MD · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2025-03-29
Completion
2026-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380999 on ClinicalTrials.gov