JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05846594

Studienbeginn:
September 2023

Letztes Update:
03.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Gastrointestinal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 4

Sponsor:
Hoffmann-La Roche

Collaborator:
Foundation Medicine

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: MO43989 https://forpatients.roche.com/
Kontakt:
Phone: 888-662-6728 (U.S. Only)
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 21)

Asklepios Klinik Gauting; Onkologisches Studienzentrum
82131 Gauting
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps

Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
20246 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps

Med. Hochschule Hannover
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps

Universität Mannheim; Personalisierte Onkologie
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU
81377 München
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps

Klinikum Stuttgart - Katharinenhospital
70174 Stuttgart
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps

Institut Sainte Catherine;Recherche Clinique
84918 Avignon
FranceRekrutierend» Google-Maps

Hopital Marie Lannelongue
92350 Le Plessis Robinson
FranceRekrutierend» Google-Maps

Centre Oscar Lambret; Chir Cancerologie General
59000 Lille
FranceAktiv, nicht rekrutierend» Google-Maps

Centre Eugène Marquis
35000 Rennes
FranceAktiv, nicht rekrutierend» Google-Maps

CHU Strasbourg - Nouvel Hopital Civil
67091 Strasbourg
FranceRekrutierend» Google-Maps

Gustave Roussy
94805 Villejuif
FranceRekrutierend» Google-Maps

Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
80131 Napoli
ItalyAktiv, nicht rekrutierend» Google-Maps

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
33100 Udine
ItalyRekrutierend» Google-Maps

Ospedale Papardo- Piemonte;Oncologia Medica
98158 Messina
ItalyAktiv, nicht rekrutierend» Google-Maps

Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
37126 Verona
ItalyAktiv, nicht rekrutierend» Google-Maps

Hagaziekenhuis, locatie Leyweg
2545 AA Den-Haag
NetherlandsZurückgezogen» Google-Maps

Medisch Centrum Leeuwarden
8934 AD Leeuwarden
NetherlandsZurückgezogen» Google-Maps

Hospital Universitario Reina Sofia; Servicio de Oncologia
14004 Córdoba
SpainRekrutierend» Google-Maps

Hospital Universitario Son Espases; Servicio de Oncologia
07014 Palma De Mallorca
SpainRekrutierend» Google-Maps

Clinica Universidad de Navarra Madrid; Servicio de Oncología
28027 Madrid
SpainRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants presenting with a clinical diagnosis of advanced cancer, falling into one

of the following two clinical presentations:

i) De novo metastatic lung cancer as evidenced by imaging demonstrating a lung

nodule/mass and objective evidence of a metastatic process; OR, ii) De novo metastatic

gastrointestinal cancer as evidenced by imaging demonstrating a metastatic 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 been

finalized.

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 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., all

immunohistochemistry staining recommended by ESMO aiming to define the treatment

decision (i.e., for lung cancer ALK, EGFR, and PD-L1 IHC staining must not have

already been performed). Participants in which tissue biopsy and primary histotyping

have been performed can be included in the study.

- Prior treatment for metastatic cancer with the exception of participants who have

already been diagnosed and treated for cancer, other than the cancer type under study,

who have no evidence of relapse

- History of malignancy within 5 years prior to screening, with the exception of the

cancer under investigation in this study and malignancies with a negligible risk of

metastasis or death (e.g., 5-year overall survival rate > 90%), such as adequately

treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized

prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Studien-Rationale

Primary outcome:

1. Median Time to Diagnosis (Time Frame - From the date of first request for biopsy (tissue or blood) by a healthcare professional to the date of complete pathologic diagnosis (up to 12 weeks))

Secondary outcome:

1. Median Time to Treatment Recommendation (Time Frame - From the date of first request for biopsy (tissue or blood) by a healthcare professional to the date of investigator's anticancer treatment recommendation (up to 12 weeks))

2. Number of Molecular Testing Failures (Time Frame - Up to 12 weeks):
Molecular testing failure is defined as cases in which the results of liquid biopsy or tissue biopsy/standard of care cannot be delivered to the treating physician.

3. Percentage of Participants in Which Comprehensive Genomic Profiling (CGP) Led to a Molecularly Guided Treatment Option (MGTO) Recommendation (Time Frame - Up to 12 weeks):
CGP refers to both the liquid biopsy and the standard of care diagnostic pathway.

4. Percentage of Participants Diagnosed with an Actionable Driver Mutation Who Did Not Receive a MGTO Because Anticancer Treatment Needed to Begin Before the CGP Results Were Available (Time Frame - Up to 12 weeks)

5. Percentage of Participants With Concordant CGP Results Between the Liquid Biopsy and the Standard of Care Diagnostic Pathway on the Gene Alteration Level (Time Frame - Up to 12 weeks)

6. Percentage of Participants in Which Treatment Recommendation Based on Molecular Data from the Liquid Biopsy Were the Same as That Based on the Standard of Care Diagnostic Pathway (Time Frame - Up to 12 weeks)

7. Percentage of Participants in Which the MGTO Recommendation Issued Was Discordant Between the Liquid Biopsy Results and the Standard of Care Diagnostic Pathway Results (Time Frame - Up to 12 weeks)

8. Incidence and Severity of Liquid Biopsy Sample Collection-Related Adverse Events (Time Frame - Up to 17 weeks)

Studien-Arme

Other: Basic Workup: Metastatic Lung Cancer Cohort
This cohort will enroll approximately 160 participants who have clinical evidence of de novo metastatic lung cancer and who have not had tissue biopsy performed prior to enrollment (classified as 'basic workup').
Other: Basic Workup: Metastatic Gastrointestinal Cancer Cohort
This cohort will enroll approximately 160 participants who have clinical evidence of de novo metastatic gastrointestinal cancer and who have not had tissue biopsy performed prior to enrollment (classified as 'basic workup').
Other: Extended Workup: Metastatic Lung Cancer Cohort
This cohort will enroll approximately 100 participants who have clinical evidence of de novo metastatic lung cancer and who have had tissue biopsy performed prior to enrollment (classified as 'extended workup').
Other: Extended Workup: Metastatic Gastrointestinal Cancer Cohort
This cohort will enroll approximately 100 participants who have clinical evidence of de novo metastatic gastrointestinal cancer and who have had tissue biopsy performed prior to enrollment (classified as 'extended workup').

Geprüfte Regime

FoundationOne® Liquid CDx Assay:
Participants will undergo liquid biopsy (FoundationOne® Liquid CDx) on blood samples collected once they have a clinical diagnosis of advanced cancer (as per label). Blood samples will be tested using the FoundationOne® Liquid CDx assay at a central laboratory. Results of the FoundationOne® Liquid CDx assay will be provided to the investigator to be used in accordance with professional guidelines in oncology for patients with malignant neoplasms.
Standard of Care Diagnostic Pathway:
Participants will undergo the local standard of care diagnostic pathway including tissue biopsy/standard of care (if tissue not available), pathology workup, and molecular workup, according to ESMO guidelines or national guidelines for each tumor type included in this study.

Quelle: ClinicalTrials.gov

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