A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer

Last updated: December 16, 2024
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

4

Condition

Gastric Ulcers

Digestive System Neoplasms

Gastrointestinal Diseases And Disorders

Treatment

FoundationOne® Liquid CDx Assay

Standard of Care Diagnostic Pathway

Clinical Study ID

NCT05846594
MO43989
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 466
Treatment Group(s): 2
Primary Treatment: FoundationOne® Liquid CDx Assay
Phase: 4
Study Start date:
September 14, 2023
Estimated Completion Date:
September 06, 2024

Connect with a study center

  • Institut Sainte Catherine;Recherche Clinique

    Avignon, 84918
    France

    Site Not Available

  • Hopital Marie Lannelongue

    Le Plessis Robinson, 92350
    France

    Site Not Available

  • Centre Oscar Lambret; Chir Cancerologie General

    Lille, 59000
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes, 35000
    France

    Site Not Available

  • CHU Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Asklepios Klinik Gauting; Onkologisches Studienzentrum

    Gauting, 82131
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    Hamburg, 20246
    Germany

    Site Not Available

  • Med. Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universität Mannheim; Personalisierte Onkologie

    Mannheim, 68167
    Germany

    Site Not Available

  • Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU

    München, 81377
    Germany

    Site Not Available

  • Asklepios Klinik München-Gauting

    München-Gauting, 82131
    Germany

    Site Not Available

  • Klinikum Stuttgart - Katharinenhospital

    Stuttgart, 70174
    Germany

    Site Not Available

  • Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

    Udine, Friuli-Venezia Giulia 33100
    Italy

    Site Not Available

  • Ospedale Papardo- Piemonte;Oncologia Medica

    Messina, Sicilia 98158
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

    Verona, Veneto 37126
    Italy

    Site Not Available

  • Hagaziekenhuis, locatie Leyweg

    Den-Haag, 2545 AA
    Netherlands

    Site Not Available

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba 14004
    Spain

    Site Not Available

  • Hospital Universitario Son Espases; Servicio de Oncologia

    Palma De Mallorca, Islas Baleares 07014
    Spain

    Site Not Available

  • Clinica Universidad de Navarra Madrid; Servicio de Oncología

    Madrid, 28027
    Spain

    Site Not Available

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