NCT03838588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

3.2 years

First QC Date

February 10, 2019

Last Update Submit

February 10, 2019

Conditions

Lung NeoplasmsLung CancerNonsmall Cell Lung CancerAdenocarcinoma of Lung

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (2)

  • Evaluation of ctDNA detecting assay in monitoring recurrence of early stage of lung cancer after radical resection.

    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.

  • 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.

Study Arms (1)

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).

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Tracking Genomic Cancer Evolution in Patients for Stage IB,II and IIIA Non-small Cell Lung Cancer After Radical Resection.

You may qualify if:

  • Provision of informed consent and assigned.
  • 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.
  • Expected radical resection.
  • Patients expected more than 3 months of survival time.
  • Willingness to comply with required protocols and give permission to use the data for clinical research and products development.

You may not qualify if:

  • Patients who want Neo-adjuvant therapy.
  • Patients with T3-4N1 Pancoast tumors (superior sulcal tumors).
  • Multi-station N2 non-small cell lung cancer with lymph node metastasis.
  • Eastern cooperative oncology group (ECOG) performance status \> 2 after postoperative chemotherapy
  • Eastern cooperative oncology group (ECOG) performance status \> 4 after postoperative targeted therapy.
  • Patients must never ever has received for any history of radiotherapy/ chemotherapy/surgery before.
  • Patients have other primary cancers.
  • Known central nervous system metastasis.
  • Patients expected less than 3 months of survival time.
  • Other situations mismatch this program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

RECRUITING

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Hebei General Hospital

Shijiazhuang, Hebei, 050051, China

RECRUITING

Tangshan People's Hospital

Tangshan, Hebei, 063001, China

RECRUITING

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Related Publications (4)

  • 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, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

    PMID: 24553385RESULT

  • 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, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.

    PMID: 27384348RESULT

  • 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, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364.

    PMID: 28445469RESULT

  • 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, Wakelee HA, Loo BW Jr, Alizadeh AA, Diehn M. Early Detection of Molecular Residual Disease in Localized Lung Cancer by Circulating Tumor DNA Profiling. Cancer Discov. 2017 Dec;7(12):1394-1403. doi: 10.1158/2159-8290.CD-17-0716. Epub 2017 Sep 24.

    PMID: 28899864RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (including plasma, white cells), tissue.

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Yi Zhang, MD

    Xuanwu Hospital, Beijing

    STUDY CHAIR

  • Yao guang Sun, MD

    Beijing Hospital

    PRINCIPAL INVESTIGATOR

  • Jie Li, MD

    Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China +86-139 1189 2587 lijie821cn@163.com

    PRINCIPAL INVESTIGATOR

  • Hong Zhang, MD

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

  • Zhi qiang Wang, MD

    Tangshan People's Hospital

    PRINCIPAL INVESTIGATOR

  • Ming He, MD

    Beijing Chest Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

  • Zi dan Wang, MD

    Beijing Chest Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

  • Li jun Liu, MD

    Hebei General Hospital

    PRINCIPAL INVESTIGATOR

  • Kang Shao, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Chao yang Liang

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Zhang, MD

CONTACT

+86-13141370703steven9130@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2019

First Posted

February 12, 2019

Study Start

November 6, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)