Trial Title:
A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer
NCT ID:
NCT05846594
Condition:
Metastatic Lung Cancer
Metastatic Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
FoundationOne® Liquid CDx Assay
Description:
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.
Arm group label:
Basic Workup: Metastatic Gastrointestinal Cancer Cohort
Arm group label:
Basic Workup: Metastatic Lung Cancer Cohort
Arm group label:
Extended Workup: Metastatic Gastrointestinal Cancer Cohort
Arm group label:
Extended Workup: Metastatic Lung Cancer Cohort
Intervention type:
Diagnostic Test
Intervention name:
Standard of Care Diagnostic Pathway
Description:
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.
Arm group label:
Basic Workup: Metastatic Gastrointestinal Cancer Cohort
Arm group label:
Basic Workup: Metastatic Lung Cancer Cohort
Arm group label:
Extended Workup: Metastatic Gastrointestinal Cancer Cohort
Arm group label:
Extended Workup: Metastatic Lung Cancer Cohort
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Sainte Catherine;Recherche Clinique
Address:
City:
Avignon
Zip:
84918
Country:
France
Facility:
Name:
Hopital Marie Lannelongue
Address:
City:
Le Plessis Robinson
Zip:
92350
Country:
France
Facility:
Name:
Centre Oscar Lambret; Chir Cancerologie General
Address:
City:
Lille
Zip:
59000
Country:
France
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Zip:
35000
Country:
France
Facility:
Name:
CHU Strasbourg - Nouvel Hopital Civil
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Facility:
Name:
Asklepios Klinik Gauting; Onkologisches Studienzentrum
Address:
City:
Gauting
Zip:
82131
Country:
Germany
Facility:
Name:
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Facility:
Name:
Med. Hochschule Hannover
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Facility:
Name:
Universität Mannheim; Personalisierte Onkologie
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Facility:
Name:
Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU
Address:
City:
München
Zip:
81377
Country:
Germany
Facility:
Name:
Klinikum Stuttgart - Katharinenhospital
Address:
City:
Stuttgart
Zip:
70174
Country:
Germany
Facility:
Name:
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Address:
City:
Udine
Zip:
33100
Country:
Italy
Facility:
Name:
Ospedale Papardo- Piemonte;Oncologia Medica
Address:
City:
Messina
Zip:
98158
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
Address:
City:
Verona
Zip:
37126
Country:
Italy
Facility:
Name:
Hospital Universitario Reina Sofia; Servicio de Oncologia
Address:
City:
Córdoba
Zip:
14004
Country:
Spain
Facility:
Name:
Hospital Universitario Son Espases; Servicio de Oncologia
Address:
City:
Palma De Mallorca
Zip:
07014
Country:
Spain
Facility:
Name:
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Start date:
September 14, 2023
Completion date:
November 15, 2024
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Collaborator:
Agency:
Foundation Medicine
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05846594
