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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03838588
• Other study ID #: T-MENC-NSCLC
• Status: Recruiting
• Start date: November 6, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2019
• Source: Geneplus-Beijing Co. Ltd.
• Contact: Yi Zhang, MD
• Phone: +86-13141370703
• Email: steven9130[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Nonsmall Cell Lung Cancer

Locations

Country	Name	City	State
China	Beijing Chest Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Hebei General Hospital	Shijiazhuang	Hebei
China	Tangshan People's Hospital	Tangshan	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Geneplus-Beijing Co. Ltd.	Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (4)

Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Grönroos E, Zambrana F, Endo — View Citation

Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hon — View Citation

Chaudhuri AA, Chabon JJ, Lovejoy AF, Newman AM, Stehr H, Azad TD, Khodadoust MS, Esfahani MS, Liu CL, Zhou L, Scherer F, Kurtz DM, Say C, Carter JN, Merriott DJ, Dudley JC, Binkley MS, Modlin L, Padda SK, Gensheimer MF, West RB, Shrager JB, Neal JW, Wakel — View Citation

Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelste — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection.	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.	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.
Primary	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.	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.	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.
Secondary	Evaluation of ctDNA detecting assay in monitoring recurrence of early stage of lung cancer after radical resection.	All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.	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.
Secondary	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.