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Spots Global Cancer Trial Database for KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

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Trial Identification

Brief Title: KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

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

Study ID: NCT05525858

Study Description

Brief Summary: A national, prospective, multi-center, open-label, multi-cohort study comprised of a framework to screen patients for actionable targets and evaluation of molecular profiling guided therapy recommended by MTB based on genomic alterations using targeted and/or immunotherapies outside of the approved indications via local clinical practice (Tier 1 \& 2) and clinical trials (Tier 3)

Detailed Description: A. The KOSMOS-II study will recruit locally advanced or metastatic solid tumor patients who had disease progression on standard first line anti-cancer treatment and/or has no standard treatment option, in order to prove MTB value to guide treatment within local clinical practice. B. After site physicians confirm that NGS results of patients are available, they preliminarily decide initial treatment before MTB submission and collect informed consent form, and then patients can register to the KOSMOS-II study. Site physicians upload patients' clinical, pathologic, and genomic data for MTB submission. If site physician cannot determine initial treatment before MTB, site physician can record 'initial treatment cannot be determined' and can register the patient for MTB. C. MTB records its treatment recommendations within available drugs list based on uploaded data, then site physicians make a final treatment decision, after informing patient about MTB decision and assessment of patients' final health status and preference. D. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and/or blood, for central NGS testing and exploratory biomarker analysis. E. Recommended treatment option There are three different options including (1) Tier 1: Therapeutic use of investigational products (KOSMOS-II drugs), (2) Tier 2: alternative treatment options, and (3) Tier 3: clinical trials

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Soonchunhyang University Hospital Bucheon, Bucheon, , Korea, Republic of

Chungbuk National University Hospital, Chungju, , Korea, Republic of

Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of

Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of

Yeungnam University Medical Center, Daegu, , Korea, Republic of

Chungnam National University Hospital, Daejeon, , Korea, Republic of

National Cancer Center, Goyang, , Korea, Republic of

Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of

Gachon University Gil Medical Center, Incheon, , Korea, Republic of

The Catholic University of Korea, Incheon St. Mary's Hospital, Incheon, , Korea, Republic of

Jeonbuk National University Hospital, Jeonju, , Korea, Republic of

Gyeongsang National University Hospital, Jinju, , Korea, Republic of

Dong-A University Hospital, Pusan, , Korea, Republic of

Cha University Bundang Medical Center, Seongnam, , Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of

Asan Medical Center, Seoul, , Korea, Republic of

Chung-ang University Hospital, Seoul, , Korea, Republic of

Ewha womans university Mokdong Hospital, Seoul, , Korea, Republic of

Gangbuk Samsung Hospital, Seoul, , Korea, Republic of

Hanyang University Hospital, Seoul, , Korea, Republic of

Korea University Anam Hospital, Seoul, , Korea, Republic of

Korea University Guro Hospital, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

The Catholic University of Korea, Seoul ST. Mary's Hospital, Seoul, , Korea, Republic of

The Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, , Korea, Republic of

Yonsei Cancer Hospital, Seoul, , Korea, Republic of

Ajou University Hospital, Suwon, , Korea, Republic of

The Catholic University of Korea, ST. Vincent's Hospital, Suwon, , Korea, Republic of

Ulsan University Hospital, Ulsan, , Korea, Republic of

Wonju Severance Christian Hospital, Wŏnju, , Korea, Republic of

Pusan National University Yangsan Hospital, Yangsan, , Korea, Republic of

Contact Details

Name: JEEHYUN KIM

Affiliation: Seoul National University Bundang Hospital

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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