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 Title
The Tracking Molecular Evolution for NSCLC (T-MENC) Study
Protocol ID
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 Period
-
Enrollment Count
200 participants
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.
Filters
Lung Neoplasms
Lung Cancer
Nonsmall Cell Lung Cancer
Adenocarcinoma of Lung
UNKNOWN
ADULT
OLDER_ADULT