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NCT Number: NCT04976296

MRD Monitoring in Lung Cancer After Resection

The conception of molecular residual disease (MRD) extending from hematologic tumor to solid tumors. Evidences supporting MRD evaluation for lung cancer by liquid biopsy has gradually accumulated, especially circulating tumor DNA (ctDNA). In this observational study, the investigators prospectively enroll stage I-IIIA non-small cell lung cancer (NSCLC) patients who underwent complete resection. Preoperative blood sample, tumor tissue and dynamic postoperative blood samples are collected continuously for MRD detection. This study aim to explore the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.

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Key information

Conditions

Lung Cancer Disease Attributes Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

There will be a rapid surge in research about molecular residual disease (MRD) for solid cancer in the near future. However, MRD differed significantly between tumor types and between contexts; there continues to be a considerable lack of awareness and knowledge about using MRD in lung cancer. Hence, this study aims to investigate the value of MRD in NSCLC patients who underwent complete resection. Preoperative blood sample (20ml), tumor tissue and dynamic postoperative blood samples (20ml) are collected continuously for MRD detection. The follow-up was performed once every 3 to 6 months. The primary objective of this study is to assess the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage I-IIIA) disease.
  • Complete resection
  • Age ≥18 years at the time of screening
  • Capable of giving signed informed consent

Exclusion criteria

  • Mixed small cell and NSCLC histology
  • Rx, R1 or R2 resection
  • History of other malignant tumors within 5 years

Treatment and study plan

MRD detection

Diagnostic Test

The Geneplus OncoMRD lung assay is used to detect the MRD status.

Other names: Geneplus OncoMRD lung assay

Primary outcomes

  1. The prognostic value of MRD

    Time frame: 5 year

    The survival difference between MRD positive and MRD negative patients.

Secondary outcomes

  1. The predictive value of MRD

    Time frame: 5 year

    The separative value adjuvant chemotherapy or target therapy in MRD positive population and MRD negative population.

  2. The lead time of MRD

    Time frame: 5 year

    The median lead time of detectable MRD before regular imaging finding.

Study contacts

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

Jia-Tao Zhang, Ph.D

CONTACT

[email protected]

020-83827812-51311

Xue-Ning Yang, Ph.D

CONTACT

[email protected]

020-83827812-51311

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

Dynamic Molecular Residual Disease Detection in Stage I-IIIA Non-Small Cell Lung Cancer After Radical Resection

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2021
Registry last updated
Mar 17, 2022

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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