The Tracking Molecular Evolution for NSCLC (T-MENC) Study

• Conditions: Lung Neoplasms; Nonsmall Cell Lung Cancer; Adenocarcinoma of Lung; Lung Cancer

• Registration Number: NCT03838588
• Lead Sponsor: Geneplus-Beijing Co. Ltd.

Brief Summary

Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection. Plasma circulating tumor DNA (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. The concordance of the relative abundance of mutations in plasma ctDNA with cancer recurrence.

Detailed Description

In the study, 200 of stage IB,II and IIIA non-small cell lung cancer patients obtained radical resection will be recruited. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy. The abundance of mutations of ctDNA was tracked at 4 time points, including:

1. st: 10 Days after patients received radical resection.

2. nd: When patients finished the chemotherapy or target drug delivery two cycles.

3. rd: 10 Days after patients finished the chemotherapy or target drug delivery four cycles.

4. th: When tumor recrudescence / 2 years after radical resection.

Tumor genomic clonal evolution was assessed by analyzing the relative abundance of mutations in plasma circulating tumor DNA (ctDNA).

Study Timeline

• Study Start: 2018-11-06
• Status Verified: 2019-02
• Study First Submitted: 2019-02-10
• Study First Submitted QC: 2019-02-10
• Last Update Submitted: 2019-02-10
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-12
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Provision of informed consent and assigned.
2. Newly diagnosed and histological or cytological confirmed stage IB-IIIA lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system.
3. Expected radical resection.
4. Patients expected more than 3 months of survival time.
5. Willingness to comply with required protocols and give permission to use the data for clinical research and products development.

Exclusion Criteria

1. Patients who want Neo-adjuvant therapy.
2. Patients with T3-4N1 Pancoast tumors (superior sulcal tumors).
3. Multi-station N2 non-small cell lung cancer with lymph node metastasis.
4. Eastern cooperative oncology group (ECOG) performance status > 2 after postoperative chemotherapy
5. Eastern cooperative oncology group (ECOG) performance status > 4 after postoperative targeted therapy.
6. Patients must never ever has received for any history of radiotherapy/ chemotherapy/surgery before.
7. Patients have other primary cancers.
8. Known central nervous system metastasis.
9. Patients expected less than 3 months of survival time.
10. Other situations mismatch this program.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection.	From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30,2021.	The tumor molecular clones and the frequency of gene mutations from 1021 tumor related genes will be detected by next-generation sequencing, which will be matched with the CT scanning.
The concordance of the plasma ctDNA detection status with Progress Free Survival (PFS) and Overall Survival (OS) after radical resection or/and under adjuvant therapy.	From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.	Plasma circulating tumor DNA (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.

Secondary Outcome Measures

Name	Time	Method
Evaluation of ctDNA detecting assay in monitoring recurrence of early stage of lung cancer after radical resection.	From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.	All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.
The molecular mechanism between the tumor recurrence and ctDNA mutations	From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.

Trial Locations

Locations (10)

Tangshan People's Hospital; 🇨🇳 Tangshan, Hebei, China

Hebei General Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The First Bethune Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Beijing Chest Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China