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

Plain-language summary

This study evaluated the contribution of the FoundationOne Liquid CDx liquid biopsy test to the diagnostic process in patients with a clinical diagnosis of advanced cancer. It included patients newly diagnosed with metastatic lung cancer or metastatic gastrointestinal cancer who had not yet received treatment for this stage. It was a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Hoffmann-La Roche

Intervention

FoundationOne® Liquid CDx Assay, Standard of Care Diagnostic Pathway

Start date

9/14/2023

Estimated completion

9/6/2024

Countries

France, Germany, Italy, Spain

Related genes

Locations

• Avignon, France
• Le Plessis-Robinson, France
• Lille, France
• Rennes, France
• Strasbourg, France
• Villejuif, France
• Hamburg, Germany
• Hanover, Germany
• Mannheim, Germany
• München, Germany
• München-Gauting, Germany
• Stuttgart, Germany
• Naples, Italy
• Udine, Italy
• Verona, Italy
• Palma de Mallorca, Spain
• Córdoba, Spain
• Madrid, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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