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MRD Monitoring in Lung Cancer After Resection

G

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status

Enrolling

Conditions

Lung Cancer

Treatments

Diagnostic Test: MRD detection

Study type

Observational

Funder types

Other

Identifiers

NCT04976296
NOTICE study

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

300 participants in 1 patient group

Stage I-IIIA NSCLC patients after complete resection
Description:
For stage I-IIIA NSCLC patients who underwent complete resection.
Treatment:
Diagnostic Test: MRD detection

Trial contacts and locations

1

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Central trial contact

Xue-Ning Yang, Ph.D; Jia-Tao Zhang, Ph.D

Data sourced from clinicaltrials.gov

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