Significance of MRD Monitoring in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer

NCT ID: NCT06081777

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2025-06-01

Brief Summary

Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.

Detailed Description

In this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. Patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.

Conditions

NSCLC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arms1：For stage III NSCLC patients who underwent complete resection.

Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery (if any), adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit.

Assigned Interventions：1021-MRD analysis

No interventions assigned to this group

Arms 2：For stage III NSCLC patients who underwent concurrent radio-chemotherapy.

Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery, adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit.

Assigned Interventions：1021-MRD analysis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80.

2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities.

3. No driving gene EGFR/ALK mutation.

4. PS = 0-1.

5. the treatment process cooperated with the provision of clinicopathological and imaging data needed in the research process, followed up and collected the blood of the clinical efficacy evaluation nodes, and agreed to use the test data for follow-up research and product development.

Exclusion Criteria

1. patients suffering from other malignant tumors.

2. patients change the treatment regimen before receiving the specified treatment or before the disease progresses.

3. Patients could not cooperate with the study for follow-up according to the defined clinical follow-up period;

4. Patients were unable to accept or provide imaging and other designated therapeutic evaluation means.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geneplus-Beijing Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuyan Wang, doctorate

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Yuyan Wang

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuyan Wang

Role: CONTACT

wangyuyan1219@aliyun.com

010-88196497

Han Yin

Role: CONTACT

01088196084

Facility Contacts

Bo Jia

Role: primary

Han Yin

Role: backup

Other Identifiers

LGH2022144

Identifier Type: -

Identifier Source: org_study_id