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

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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