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
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