Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD
NCT ID: NCT05457049
Last Updated: 2022-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
180 participants
OBSERVATIONAL
2022-08-01
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Undetectable MRD
Stage IB-IIIA NSCLC patients who after complete resection. And patients who maintain MRD negativity in two-round MRD landmark test (first in 3-7 days after surgery, second in 1 months ±7 days after surgery) will be enrolled. And patients will be under close dynamic monitoring at least two years.
Molecular residual disease test
OncoMRD Lung
Interventions
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Molecular residual disease test
OncoMRD Lung
Eligibility Criteria
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Inclusion Criteria
* ≥18 years.
* Two-round MRD tests confirm landmark undetectable MRD.
* Expected survival ≥12 weeks.
* Expected survival ≥12 weeks.
* ECOG PS 1-2.
* Willing to accept MRD monitoring every 3 months for a total of 2 years after operation.
Exclusion Criteria
* Patients with a history of other malignancies in the past 5 years.
* Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.).
18 Years
ALL
No
Sponsors
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Guangdong Association of Clinical Trials
OTHER
Responsible Party
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Yi-Long Wu
Principal Investigator
Locations
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Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Wen-Zhao Zhong, MD
Role: primary
References
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Zhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486.
Zhang JT, Dong S, Gu WQ, Zhao N, Liang Y, Tang WF, Liu SY, Wang F, Wang GS, Peng B, Wu N, Yan S, Geng GJ, Xie ZF, Yang YL, Zhang JH, Zhang T, Yang N, Jiao WJ, Xiong YY, Cai M, Li F, Chen RR, Yan HH, Maggie Liu SY, Yi X, Zhong WZ, Yang XN, Wu YL. Adjuvant Therapy-Free Strategy for Stage IB to IIIA Non-Small-Cell Lung Cancer Patients After Radical Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study (CTONG 2201). Clin Lung Cancer. 2024 Jan;25(1):e1-e4. doi: 10.1016/j.cllc.2023.09.008. Epub 2023 Oct 6.
Other Identifiers
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CTONG 2201
Identifier Type: -
Identifier Source: org_study_id
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