MRD Monitoring in Lung Cancer After Resection

Recruiting

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: MRD detection

• Registration Number: NCT04976296
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-26
• Study Start: 2021-09-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17
• Primary Completion: 2027-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage I-IIIA NSCLC patients after complete resection	MRD detection	For stage I-IIIA NSCLC patients who underwent complete resection.

Primary Outcome Measures

Name	Time	Method
The prognostic value of MRD	5 year	The survival difference between MRD positive and MRD negative patients.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China