Phase
Condition
Gastric Ulcers
Digestive System Neoplasms
Gastrointestinal Diseases And Disorders
Treatment
FoundationOne® Liquid CDx Assay
Standard of Care Diagnostic Pathway
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants presenting with a clinical diagnosis of advanced cancer, falling intoone of the following two clinical presentations: i) De novo metastatic lung cancer as evidenced by imaging demonstrating a lungnodule/mass and objective evidence of a metastatic process; OR, ii) De novometastatic gastrointestinal cancer as evidenced by imaging demonstrating ametastatic process in the abdomen/pelvis
Participants who are treatment naïve for the metastatic setting under study
Ability to comply with the study protocol
Participants must either: i) Have a tissue biopsy intended/planned to confirm malignant disease and histology;OR, ii) Have a tissue biopsy already performed but pathology has not yet beenfinalized.
If a tissue biopsy has already been performed prior to ICF signature, then the subtyping of primary tumor may have already been assessed (i.e., for lung cancer TTF1, p40, and napsin A IHC staining may have already been performed).
Exclusion
Exclusion Criteria:
Participants deemed not fit for treatment with systemic therapy
Participants deemed not fit for tissue biopsy
Participants with hematological neoplasm
Participants with primary malignant neoplasm of the brain
Participants with any previous molecular testing (NGS or other methods) e.g., allimmunohistochemistry staining recommended by ESMO aiming to define the treatmentdecision (i.e., for lung cancer ALK, EGFR, and PD-L1 IHC staining must not havealready been performed). Participants in which tissue biopsy and primary histotypinghave been performed can be included in the study.
Prior treatment for metastatic cancer with the exception of participants who havealready been diagnosed and treated for cancer, other than the cancer type understudy, who have no evidence of relapse
History of malignancy within 5 years prior to screening, with the exception of thecancer under investigation in this study and malignancies with a negligible risk ofmetastasis or death (e.g., 5-year overall survival rate > 90%), such as adequatelytreated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localizedprostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Study Design
Connect with a study center
Institut Sainte Catherine;Recherche Clinique
Avignon, 84918
FranceSite Not Available
Hopital Marie Lannelongue
Le Plessis Robinson, 92350
FranceSite Not Available
Centre Oscar Lambret; Chir Cancerologie General
Lille, 59000
FranceSite Not Available
Centre Eugène Marquis
Rennes, 35000
FranceSite Not Available
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Asklepios Klinik Gauting; Onkologisches Studienzentrum
Gauting, 82131
GermanySite Not Available
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, 20246
GermanySite Not Available
Med. Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Universität Mannheim; Personalisierte Onkologie
Mannheim, 68167
GermanySite Not Available
Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU
München, 81377
GermanySite Not Available
Asklepios Klinik München-Gauting
München-Gauting, 82131
GermanySite Not Available
Klinikum Stuttgart - Katharinenhospital
Stuttgart, 70174
GermanySite Not Available
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
Napoli, Campania 80131
ItalySite Not Available
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli-Venezia Giulia 33100
ItalySite Not Available
Ospedale Papardo- Piemonte;Oncologia Medica
Messina, Sicilia 98158
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
Verona, Veneto 37126
ItalySite Not Available
Hagaziekenhuis, locatie Leyweg
Den-Haag, 2545 AA
NetherlandsSite Not Available
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
NetherlandsSite Not Available
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba 14004
SpainSite Not Available
Hospital Universitario Son Espases; Servicio de Oncologia
Palma De Mallorca, Islas Baleares 07014
SpainSite Not Available
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
SpainSite Not Available
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