Lung NeoplasmsNCT03838588
The Tracking Molecular Evolution for NSCLC (T-MENC) Study
An observational study of Lung Neoplasms and Lung Cancer, run by Geneplus-Beijing Co. Ltd. at 10 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Neoplasms, Lung Cancer, Nonsmall Cell Lung Cancer
- How many people
- 200 participants
- Where
- 10 sitesChina
- Study dates
- 6 Nov 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tracking Genomic Cancer Evolution in Patients for Stage IB,II and IIIA Non-small Cell Lung Cancer After Radical Resection.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Patients have other primary cancers.
- Known central nervous system metastasis.
- Patients expected less than 3 months of survival time.
- Other situations mismatch this program.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
Yao Guang Sun, MD, +86-13601310875, sunyaoguang@hotmail.com
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Kang Shao, MD, +86-13901191120, 13901191120@139.com
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Chao yang Liang, MD, +86-18610570066, chaoyangliang@hotmail.com
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Jie Li, MD, +86-13911892587, lijie821cn@163.com
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Yi Zhang, MD, +86-13141370703, steven9130@sina.com
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
Zi dan Wang, MD, +86-13501272331, wztdoctor@163.com
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Hong Zhang, MD, +86-13514468707, yveszhang@hotmail.com
- Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Ming He, MD, +86-13833187902, heming6699@sina.com
- Recruiting
Hebei General Hospital
Shijiazhuang, Hebei, 050051
Li jun Liu, MD, +86-13833131067, 13833131067@163.com
- Recruiting
Tangshan People's Hospital
Tangshan, Hebei, 063001
Zhi qiang Wang, MD, +86-13333299798, 737703213@qq.com
About this 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
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.
Read the 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:
- 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).
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start6 Nov 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, MD, Study chair, Xuanwu Hospital, BeijingYao guang Sun, MD, Principal investigator, Beijing HospitalJie Li, MD, Principal investigator, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China +86-139 1189 2587 lijie821cn@163.comHong Zhang, MD, Principal investigator, The First Hospital of Jilin UniversityZhi qiang Wang, MD, Principal investigator, Tangshan People's HospitalMing He, MD, Principal investigator, Beijing Chest Hospital, Capital Medical UniversityZi dan Wang, MD, Principal investigator, Beijing Chest Hospital, Capital Medical UniversityLi jun Liu, MD, Principal investigator, Hebei General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838588
- Sponsor's protocol ID
- T-MENC-NSCLC
- Status last verified
- Feb 2019
- First submitted
- 10 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24553385Tie 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.
PubMed 27384348Abbosh 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.
PubMed 28445469Chaudhuri 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.
PubMed 28899864
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03838588
- Acronym / sponsor ID
- T-MENC-NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Geneplus-Beijing Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tracking Genomic Cancer Evolution in Patients for Stage IB,II and IIIA Non-small Cell Lung Cancer After Radical Resection.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
Time frame: 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 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.
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.
Time frame: 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.
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.
2 secondary outcomes
Evaluation of ctDNA detecting assay in monitoring recurrence of early stage of lung cancer after radical resection.
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Results publication: PubMed 24553385Bettegowda 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.
- Results publication: PubMed 27384348Tie 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.
- Results publication: PubMed 28445469Abbosh 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.
- Results publication: PubMed 28899864Chaudhuri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Zhang, MD study chair
Xuanwu Hospital, Beijing
Yao guang Sun, MD principal investigator
Beijing Hospital
Jie Li, MD principal investigator
Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China +86-139 1189 2587 lijie821cn@163.com
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Lung Cancer, run by Geneplus-Beijing Co. Ltd. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang, MD (+86-13141370703, steven9130@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection. (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03838588, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.