MRD Monitoring in Lung Cancer After Resection

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04976296

Enrollment

300

Registered

2021-07-26

Start date

2021-09-01

Completion date

2027-12-30

Last updated

2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Molecular residual disease, Circulating tumor DNA, Disease relapse, Predictive value

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTMRD detection

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The prognostic value of MRD	5 year	The survival difference between MRD positive and MRD negative patients.

Secondary

Measure	Time frame	Description
The predictive value of MRD	5 year	The separative value adjuvant chemotherapy or target therapy in MRD positive population and MRD negative population.
The lead time of MRD	5 year	The median lead time of detectable MRD before regular imaging finding.

Countries

China

Contacts

Primary ContactXue-Ning Yang, Ph.D

yangxuening@gdph.org.cn020-83827812-51311

Backup ContactJia-Tao Zhang, Ph.D

Z18820792959@hotmail.com020-83827812-51311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026