Brief Title
The Tracking Molecular Evolution for NSCLC (T-MENC) Study
Official Title
Tracking Genomic Cancer Evolution in Patients for Stage IB,II and IIIA Non-small Cell Lung Cancer After Radical Resection: The Tracking Molecular Evolution for NSCLC (T-MENC) Study
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 Type
Observational
Primary Outcome
Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection.
Secondary Outcome
Evaluation of ctDNA detecting assay in monitoring recurrence of early stage of lung cancer after radical resection.
Condition
Lung Neoplasms
Study Arms / Comparison Groups
T-MENC Study Group
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: st: 10 Days after patients received radical resection. nd: When patients finished the chemotherapy or target drug delivery two cycles. rd: 10 Days after patients finished the chemotherapy or target drug delivery four cycles. 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
200
Start Date
November 6, 2018
Completion Date
December 31, 2021
Primary Completion Date
December 31, 2021
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Yi Zhang, MD, +86-13141370703, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03838588
Organization ID
T-MENC-NSCLC
Responsible Party
Sponsor
Study Sponsor
Geneplus-Beijing Co. Ltd.
Collaborators
Xuanwu Hospital, Beijing
Study Sponsor
Yi Zhang, MD, Study Chair, Xuanwu Hospital, Beijing
Verification Date
February 2019