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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-06

Study Completion Date

2021-12-31

Brief Summary

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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.

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RECRUITING

Detailed Description

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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).

Conditions

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Lung Neoplasms Lung Cancer Nonsmall Cell Lung Cancer Adenocarcinoma of Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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T-MENC Study Group

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).

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi Zhang, MD

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Yao guang Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Jie Li, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China +86-139 1189 2587 [email protected]

Hong Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Zhi qiang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Tangshan People's Hospital

Ming He, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chest Hospital, Capital Medical University

Zi dan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chest Hospital, Capital Medical University

Li jun Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Hebei General Hospital

Kang Shao, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Chao yang Liang

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

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