MRD Monitoring in Lung Cancer After Resection

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976296
• Other study ID #: NOTICE study
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 30, 2027

Study information

• Verified date: March 2022
• Source: Guangdong Provincial People's Hospital
• Contact: Xue-Ning Yang, Ph.D
• Phone: 020-83827812-51311
• Email: yangxuening[@]gdph.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• MRD detection
The Geneplus OncoMRD lung assay is used to detect the MRD status.

Locations

Country	Name	City	State
China	Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (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. Review. — View Citation

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. — View Citation

Pantel K, Alix-Panabières 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prognostic value of MRD	The survival difference between MRD positive and MRD negative patients.	5 year
Secondary	The predictive value of MRD	The separative value adjuvant chemotherapy or target therapy in MRD positive population and MRD negative population.	5 year
Secondary	The lead time of MRD	The median lead time of detectable MRD before regular imaging finding.	5 year