Evidence map›Paper›PMID 38724991›Full record

ArticleBMC cancer2024

Pragmatic nationwide master observational trial based on genomic alterations in advanced solid tumors: KOrean Precision Medicine Networking Group Study of MOlecular profiling guided therapy based on genomic alterations in advanced Solid tumors (KOSMOS)-II study protocol KCSG AL-22-09.

Sun Young Kim, Jee Hyun Kim, Tae-Yong Kim, Sook Ryun Park, Shinkyo Yoon, Soohyeon Lee, Se-Hoon Lee, Tae Min Kim, Sae-Won Han, Hye Ryun Kim and 10 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05525858 (KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05525858 recruitingnot on this map

KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

TypeobservationalSponsorSeoul National University Bundang HospitalRan2022 to 2027Enrolled1,000ConditionsSolid Tumor, Advanced Solid Tumor, Metastatic CancerArmsAlectinib, Atezolizumab, Erlotinib, Trastuzumab + Pertuzumab, Trastuzumab emtansine
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
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  3. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Sun Young KimDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Jee Hyun KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. jhkimmd@snu.ac.kr.
Tae-Yong KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.
Sook Ryun ParkDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Shinkyo YoonDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Soohyeon LeeDepartment of Internal Medicine, Korea University College of Medicine, Korea University Anam Hospital, Seoul, South Korea.
Se-Hoon LeeDepartment of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Tae Min KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.
Sae-Won HanDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.
Hye Ryun KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Yonsei Cancer Center, Seoul, South Korea.
Hongseok YunCenter for Genomic Medicine, Seoul National University Hospital, Seoul, South Korea.
Sejoon LeeCenter for Precision Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Jihun KimDepartment of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Yoon-La ChoiDepartment of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Kui Son ChoiDepartment of Cancer Control and Population Health, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, South Korea.
Heejung ChaeDepartment of Internal Medicine, National Cancer Center, Goyang, South Korea.
Hyewon RyuDivision of Hematology and Oncology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, South Korea.
Gyeong-Won LeeDivision of Hematology-Oncology, Department of Internal Medicine, Institute of Health Science, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Jinju, South Korea.
Dae Young ZangDepartment of Internal Medicine, Hallym University College of Medicine, Hallym University Sacred Heart Hospital, Anyang, South Korea.
Joong Bae AhnDivision of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Yonsei Cancer Center, Seoul, South Korea.

Funding

Ministry of Health and Welfare, Republic of Korea HA22C0052
6 · The paper itself

Abstract

backgroundNext-generation sequencing (NGS) has been introduced to many Korean institutions to support molecular diagnostics in cancer since 2017, when it became eligible for reimbursement by the National Health Insurance Service. However, the uptake of molecularly guided treatment (MGT) based on NGS results has been limited because of stringent regulations regarding prescriptions outside of approved indications, a lack of clinical trial opportunities, and limited access to molecular tumor boards (MTB) at most institutions. The KOSMOS-II study was designed to demonstrate the feasibility and effectiveness of MGT, informed by MTBs, using a nationwide precision medicine platform.

methodsThe KOSMOS-II trial is a large-scale nationwide master observational study. It involves a framework for screening patients with metastatic solid tumors for actionable genetic alterations based on local NGS testing. It recommends MGT through a remote and centralized MTB meeting held biweekly. MGT can include one of the following options: Tier 1, the therapeutic use of investigational drugs targeting genetic alterations such as ALK, EGFR, ERBB2, BRAF, FH, ROS1, and RET, or those with high tumor mutational burden; Tier 2, comprising drugs with approved indications or those permitted for treatment outside of the indications approved by the Health Insurance Review and Assessment Service of Korea; Tier 3, involving clinical trials matching the genetic alterations recommended by the MTB. Given the anticipated proportion of patients receiving MGT in the range of 50% ± 3.25%, this study aims to enroll 1,000 patients. Patients must have progressed to one or more lines of therapy and undergone NGS before enrollment. DISCUSSION: This pragmatic master protocol provides a mass-screening platform for rare genetic alterations and high-quality real-world data. Collateral clinical trials, translational studies, and clinico-genomic databases will contribute to generating evidence for drug repositioning and the development of new biomarkers.

trial registrationNCT05525858.

Indexed as

Molecular Targeted TherapyNeoplasmsPrecision MedicineBiomarkers, TumorGenomicsHigh-Throughput Nucleotide SequencingHumansMutationObservational Studies as TopicPragmatic Clinical Trials as TopicRepublic of KoreaBiomarkers, TumorMaster observational trialMolecular tumor boardNext-generation sequencing

Identifiers

PMID38724991
PMCPMC11080169

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.