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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-14

Study Completion Date

2024-09-06

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Lung Cancer Metastatic Gastrointestinal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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').

Group Type OTHER