An interventional study of biopsy liquid in Metastatic Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Recruiting at 21 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Other
This is a prospective biomarker study that aims at demonstrating the impact of liquid biopsy to deliver better treatment for cancer patients with metastatic disease managed in the community setting
Patients will be selected to present a metastatic cancer (de novo or relapse after primary tumor treatment) eligible for a first line treatment (chemotherapy, immunotherapy, endocrine therapy or targeted therapy).
All tumor subtype could be enrolled in the study; metastatic prostate cancer must be resistant to castration. Triple negative breast cancer and Hormone receptor positive, Her2-negative metastatic breast cancer resistant to endocrine therapy are eligible to the study.
A plasma sample will be collected at baseline and will be tested for a large panel of gene and MSI status using Next Generation Sequencing (NGS) (cf table). Results will be discussed within a Molecular Tumor Board (MTB) with all declared centers.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are eligible to be included in the study only if they meet all of the following criteria:
Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following criteria:
Patients presenting for whom ct DNA sequencing
Biological: biopsy liquid
Patient performs a blood test at treatment baseline
Proportion of patients for whom ctDNA sequencing
The primary objective of the study will be to evaluate the impact of ctDNA sequencing on the treatment plan of cancer patients managed in satellite centers. This will be performed by estimating the proportion of patients for whom ctDNA sequencing has allowed to propose a systemic treatment that was not considered before the clinician.
Time frame: 72 months
Utilization rates of molecular profiling information
The utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)
Time frame: 72 months
Rate of molecular screening failure
Time frame: 72 months
Relapsed time between liquid biopsy and matched therapy onset
Time frame: 72 months
Rate of patients presenting targetable alterations
The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions)
Time frame: 72 months
Utilization rate of tumor mutational burden
The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels)
Time frame: 72 months
Objective Response Rate
Time frame: 72 months
Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing
Time frame: 72 months
Plan to share: No — no IPD in this study
No publications or documents are linked to this record.
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Gustave Roussy, Cancer Campus, Grand Paris