Screening Study for Participants With Malignant Tumors
- Conditions
- Solid Tumors
- Interventions
- Other: Screening platform
- Registration Number
- NCT05419375
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol
- Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial
Inclusion Criteria for Participants with Stage III NSCLC
- Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Inclusion Criteria for Participants with Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC Requiring Adjuvant Treatment
- Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017)
- Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor)
- Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol
- Representative FFPE tumor specimen obtained prior to the start of any treatment
- ECOG Performance Status of 0 or 1
General
- History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
- Any condition that may affect the interpretation of study results
- Significant liver or cardiovascular disease
- Prior allogenic stem-cell or solid-organ transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Non-Small Cell Lung Cancer (NSCLC) Screening platform Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.
- Primary Outcome Measures
Name Time Method Proportion of participants eligible for a linked Roche clinical trial Up to 10 years Proportion of participants with evaluable biomarker results Up to 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (156)
Royal Marsden Hospital
🇬🇧London, United Kingdom
Christie Hospital Nhs Trust
🇬🇧Manchester, United Kingdom
Clinica CIMCA
🇨🇷San José, Costa Rica
The Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Marmara Uni Faculty of Medicine
🇹🇷Istanbul, Turkey
Medikal Park Samsun
🇹🇷Samsun, Turkey
Medical Park Seyhan Hospital
🇹🇷Seyhan, Turkey
Instituto Cancerología Medellin
🇨🇴Medellin, Colombia
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
Southern California Kaiser Permanente
🇺🇸San Diego, California, United States
Rocky Mountain Cancer Centers-Penrose Pavillion
🇺🇸Longmont, Colorado, United States
Oregon Health Sciences Uni
🇺🇸Portland, Oregon, United States
Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
Texas Oncology, P.A.
🇺🇸San Antonio, Texas, United States
Mays Cancer Center, UT Health San Antonio
🇺🇸San Antonio, Texas, United States
Texas Oncology- Northeast Texas
🇺🇸Tyler, Texas, United States
Oncology & Hematology Associates of Southwest Virginia, Inc
🇺🇸Blacksburg, Virginia, United States
Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
Lifehouse
🇦🇺Camperdown, New South Wales, Australia
GenesisCare North Shore
🇦🇺St Leonards, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
One Clinical Research
🇦🇺Nedlands, Western Australia, Australia
GHdC Site Les Viviers
🇧🇪Charleroi, Belgium
UZ Gent
🇧🇪Gent, Belgium
Hospital Sao Rafael - HSR
🇧🇷Salvador, Bahia, Brazil
Crio - Centro Regional Integrado de Oncologia
🇧🇷Fortaleza, Ceará, Brazil
Oncocentro Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
COT - Centro Oncologico do Triangulo
🇧🇷Uberlandia, Minas Gerais, Brazil
Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Clínica de Oncologia Reichow
🇧🇷Blumenau, Santa Catarina, Brazil
Hospital de Cancer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
🇧🇷Sao Jose do Rio Preto, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao Paulo, São Paulo, Brazil
Oncoclinicas Rio de Janeiro S.A.
🇧🇷Rio de Janeiro, Brazil
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
K2 Oncology
🇨🇱Providencia, Chile
OrlandiOncología
🇨🇱Santiago, Chile
Centro de Estudios Clínicos SAGA
🇨🇱Santiago, Chile
RedSalud Vitacura
🇨🇱Santiago, Chile
James Lind Centro de Investigación Del Cáncer
🇨🇱Temuco, Chile
Clinica De La Costa
🇨🇴Barranquilla, Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
🇨🇴Bogota, D.C., Colombia
Hospital Universitario San Ignacio
🇨🇴Bogota, Colombia
ICIMED Instituto de Investigación en Ciencias Médicas
🇨🇷San José, Costa Rica
CHU Angers,Service de Pneumologie
🇫🇷Angers, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Centre Francois Baclesse
🇫🇷Caen, France
Centre Leon Berard
🇫🇷Lyon, France
CHU Strasbourg - Nouvel Hopital Civil
🇫🇷Strasbourg, France
Hia Sainte Anne
🇫🇷Toulon, France
Zentralklinikum Augsburg
🇩🇪Augsburg, Germany
Klinikum Esslingen
🇩🇪Esslingen, Germany
Asklepios Klinik Gauting
🇩🇪München-Gauting, Germany
LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik V, Campus Innenstadt
🇩🇪München, Germany
Klinikum rechts der Isar der TU Muenchen
🇩🇪München, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Rajiv Gandhi Cancer Inst.&Research Center
🇮🇳New Delhi, Delhi, India
Medanta -The Medicity
🇮🇳Gurgaon, Haryana, India
Tata Memorial Hospital
🇮🇳Mumbai, Maharashtra, India
Apollo Gleneagles Hospital
🇮🇳Kolkata, WEST Bengal, India
Rambam Medical Center
🇮🇱Haifa, Israel
Rabin Medical Center-Beilinson Campus
🇮🇱Petach Tikva, Israel
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
🇮🇹Meldola, Emilia-Romagna, Italy
IRCCS Istituto Regina Elena (IFO)
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Lazio, Italy
IRCCS A.O.U San MArtino - IST
🇮🇹Genova, Liguria, Italy
Asst Degli Spedali Civili Di Brescia
🇮🇹Brescia, Lombardia, Italy
Irccs Istituto Europeo di Oncologia (IEO)
🇮🇹Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Lombardia, Italy
A.O. Universitaria S. Luigi Gonzaga
🇮🇹Orbassano, Piemonte, Italy
IRCCS Giovanni Paolo II Istituto Oncologico
🇮🇹Bari, Puglia, Italy
Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
IRCCS Istituto Oncologico Veneto (IOV)
🇮🇹Padova, Veneto, Italy
Aichi Cancer Center Hospital
🇯🇵Aichi, Japan
Hirosaki University Hospital
🇯🇵Aomori, Japan
Shikoku Cancer Center
🇯🇵Ehime, Japan
NHO Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Kurume University Hospital
🇯🇵Fukuoka, Japan
Kobe City Medical Center General Hospital
🇯🇵Hyogo, Japan
National Hospital Organization Himeji Medical Center
🇯🇵Hyogo, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Kanagawa Cancer Center
🇯🇵Kanagawa, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Sendai Kousei Hospital
🇯🇵Miyagi, Japan
Nara Medical University Hospital
🇯🇵Nara, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Kurashiki Central Hospital
🇯🇵Okayama, Japan
Kindai University Hospital
🇯🇵Osaka-sayama, Japan
Osaka City General Hospital
🇯🇵Osaka, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
NHO Kinki Chuo Chest Medical Center
🇯🇵Osaka, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
Komagome Hospital
🇯🇵Tokyo, Japan
Tottori University Hospital
🇯🇵Tottori, Japan
National Hospital Organization Yamaguchi - Ube Medical Center
🇯🇵Yamaguchi, Japan
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Civil de Guadalajara Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Clinstile S.A de C.V.
🇲🇽Mexico City, Mexico CITY (federal District), Mexico
Centro de Investigación Oncologica Galerias
🇲🇽Aguascalientes, Mexico
ARKE Estudios Clínicos S.A. de C.V.
🇲🇽Ciudad de México, Mexico
Instituto Nacional de Cancerologia
🇲🇽Mexico City, Mexico
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Auckland City Hospital, Cancer and Blood Research
🇳🇿Auckland, New Zealand
Oslo university hospital Radiumhospitalet
🇳🇴Oslo, Norway
Instytut Genetyki i Immunologii GENIM
🇵🇱Lublin, Poland
Dolno?l?skie Centrum Chorób P?uc we Wroc?awiu
🇵🇱Wroc?aw, Poland
University Clinical Centre of Serbia
🇷🇸Belgrade, Serbia
Hospital Medical Center Bezanijska kosa
🇷🇸Belgrade, Serbia
Univ Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Institute for pulmonary diseases of Vojvodina
🇷🇸Sremska Kamenica, Serbia
National Cancer Centre
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Barts & London School of Med
🇬🇧London, United Kingdom
Complejo Hospitalario Universitario Insular?Materno Infantil
🇪🇸Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital General Univ. de Alicante
🇪🇸Alicante, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
National Cheng Kung Univ Hosp
🇨🇳Tainan, Taiwan
National Taiwan Uni Hospital
🇨🇳Taipei City, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
Taipei Municipal Wan Fang Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou
🇨🇳Taoyuan, Taiwan
Taichung Veterans General Hospital
🇨🇳Xitun Dist., Taiwan
National Cancer Institute
🇹🇭Bangkok, Thailand
Rajavithi Hospital
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hosp
🇹🇭Chang Mai, Thailand
Oncology Unit, Faculty of Medicine, Vajira Hospital
🇹🇭Dusit, Thailand
Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
Central Chest Institute of Thailand
🇹🇭Nonthaburi, Thailand
Songklanagarind Hospital
🇹🇭Songkhla, Thailand
Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
🇹🇷Ankara, Turkey
Gazi Uni Medical Faculty Hospital
🇹🇷Ankara, Turkey
Liv Hospital Ankara
🇹🇷Ankara, Turkey
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
🇹🇷Bakirkoy / Istanbul, Turkey
Dicle University Faculty of Medicine
🇹🇷Diyarbakir, Turkey
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
🇹🇷Erzurum, Turkey
Medipol University Medical Faculty
🇹🇷Istanbul, Turkey