Spots Global Cancer Trial Database for A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer
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Trial Identification
Brief Title: A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer
Official Title: An International Prospective Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (L1ST)
Study ID: NCT05846594
Study Description
Brief Summary: This is an international, prospective study to assess the impact of concomitant early use of liquid biopsy (FoundationOne® Liquid CDx) within the diagnostic pathway, compared with the standard of care diagnostic pathway, on the timing of routine cancer care in treatment-naïve participants presenting with a clinical diagnosis of advanced cancer, where the pathologic diagnosis has not yet been confirmed. Participants with one of the following two clinical presentations will be included: participants with evidence of de novo metastatic lung cancer or participants with evidence of de novo metastatic gastrointestinal cancer. Participants may have undergone different levels of diagnostic workup prior to enrollment. Participants who have not had tissue biopsy performed prior to enrollment will be classified as 'basic workup' and those who have had tissue biopsy performed prior to enrollment will be classified as 'extended workup'. During the diagnosis period, eligible participants will undergo liquid biopsy (FoundationOne® Liquid CDx assay; as per label) on blood samples. Blood samples will be tested using the FoundationOne® Liquid CDx assay at a central laboratory. In parallel, participants will undergo the standard of care diagnostic pathway, including tissue biopsy and histology workup, if not already done before enrollment, and molecular workup according to ESMO guidelines or national guidelines for each tumor type included in this study. Once a complete pathologic diagnosis has been made, the investigator (or multidisciplinary team) can complete an anti-cancer treatment recommendation assessment. Anti-cancer treatment recommendation should follow current practice and professional guidelines based on the results provided by either liquid biopsy (as per label) or tissue biopsy/standard of care.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut Sainte Catherine;Recherche Clinique, Avignon, , France
Hopital Marie Lannelongue, Le Plessis Robinson, , France
Centre Oscar Lambret; Chir Cancerologie General, Lille, , France
Centre Eugène Marquis, Rennes, , France
CHU Strasbourg - Nouvel Hopital Civil, Strasbourg, , France
Gustave Roussy, Villejuif, , France
Asklepios Klinik Gauting; Onkologisches Studienzentrum, Gauting, , Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II, Hamburg, , Germany
Med. Hochschule Hannover, Hannover, , Germany
Universität Mannheim; Personalisierte Onkologie, Mannheim, , Germany
Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU, München, , Germany
Klinikum Stuttgart - Katharinenhospital, Stuttgart, , Germany
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica, Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia, Udine, Friuli-Venezia Giulia, Italy
Ospedale Papardo- Piemonte;Oncologia Medica, Messina, Sicilia, Italy
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia, Verona, Veneto, Italy
Hagaziekenhuis, locatie Leyweg, Den-Haag, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Hospital Universitario Son Espases; Servicio de Oncologia, Palma De Mallorca, Islas Baleares, Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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