MRD Monitoring in Lung Cancer After Resection

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

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: MRD detection

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Xue-Ning Yang, Ph.D; Phone Number: 020-83827812-51311; Email: yangxuening@gdph.org.cn
• Study Contact Backup: Name: Jia-Tao Zhang, Ph.D; Phone Number: 020-83827812-51311; Email: Z18820792959@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Recruiting
      • Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital
      • Contact: Xue-Ning Yang, Ph.D; Phone Number: 020-83827812-51311; Email: yangxuening@gdph.org.cn
      • Contact: Jia-Tao Zhang, Ph.D; Phone Number: 020-83827812-51311; Email: Z18820792959@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The pathological diagnosis confirmed stage I-IIIA NSCLC patients who underwent complete resection. No history of other malignant tumors within 5 years.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage I-IIIA NSCLC patients after complete resection; For stage I-IIIA NSCLC patients who underwent complete resection.	Diagnostic test: MRD detection; The Geneplus OncoMRD lung assay is used to detect the MRD status.; Other Names: Geneplus OncoMRD lung assay

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Publications and helpful links

General Publications

• Pantel K, Alix-Panabieres C. Liquid biopsy and minimal residual disease - latest advances and implications for cure. Nat Rev Clin Oncol. 2019 Jul;16(7):409-424. doi: 10.1038/s41571-019-0187-3.
• Abbosh C, Birkbak NJ, Swanton C. Early stage NSCLC - challenges to implementing ctDNA-based screening and MRD detection. Nat Rev Clin Oncol. 2018 Sep;15(9):577-586. doi: 10.1038/s41571-018-0058-3.
• Chaudhuri AA, Chabon JJ, Lovejoy AF, Newman AM, Stehr H, Azad TD, Khodadoust MS, Esfahani MS, Liu CL, Zhou L, Scherer F, Kurtz DM, Say C, Carter JN, Merriott DJ, Dudley JC, Binkley MS, Modlin L, Padda SK, Gensheimer MF, West RB, Shrager JB, Neal JW, Wakelee HA, Loo BW Jr, Alizadeh AA, Diehn M. Early Detection of Molecular Residual Disease in Localized Lung Cancer by Circulating Tumor DNA Profiling. Cancer Discov. 2017 Dec;7(12):1394-1403. doi: 10.1158/2159-8290.CD-17-0716. Epub 2017 Sep 24.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): December 30, 2027
• Study Completion (Anticipated): December 30, 2027

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Circulating tumor DNA; Molecular residual disease; Predictive value; Disease relapse
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: NOTICE study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The IPD could be shared after seeking consent from the corresponding investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No