Metastatic Cancer
Conditions
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALbiopsy liquid
Patient performs a blood test at treatment baseline
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Proportion of patients presenting for whom ct DNA sequencing has allowed to propose a systemic treatment that was not considered before by the clinician.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants are eligible to be included in the study only if they meet all of the following criteria: 1. Age ≥ 18 years 2. Histology: solid malignant tumor 3. Locally advanced/unresectable and/or metastatic (for prostate cancer: castration resistant prostate cancer, for RH+/HER2- breast cancer: prior treatment with endocrine therapy plus anti-CDK4/6 inhibitor) 4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 5. Measurable disease as per RECIST criteria 6. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code) 7. Voluntary signed and dated written informed consent prior to any study specific procedure.
Exclusion criteria
Participants will be excluded from the study if they meet any of the following criteria: 1. Radiological evidence of symptomatic or progressive brain metastases 2. Previous or current malignancies of others histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer 3. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol 4. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent 5. Minors (Age \< 18 years) 6. Pregnant or breast-feeding women 7. Previous enrollment in the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients for whom ctDNA sequencing | 72 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of molecular screening failure | 72 months | — |
| Relapsed time between liquid biopsy and matched therapy onset | 72 months | — |
| Rate of patients presenting targetable alterations | 72 months | The rate of patients presenting targetable alterations according to alterations subtypes (copy number/mutation/oncogenic fusions) |
| Utilization rates of molecular profiling information | 72 months | The utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies) |
| Objective Response Rate | 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 | 72 months | — |
| Utilization rate of tumor mutational burden | 72 months | The utilization rate of tumor mutational burden (TMB - based on new generation sequencing panels) |
Countries
France, French Polynesia, New Caledonia
Contacts
Primary ContactBenjamin Verret, MD
Backup ContactAntoine Italiano, MD
Outcome results
None listed