Improved Management of Soft Tissue Sarcomas Patients With an Optimized and Innovative Sorting Technology for Circulating Tumor Cells

Overview

This trial is a monocentric, clinico-biological cohort study with prospective enrollment, aiming to develop a method for detecting and sorting CTCs (circulating tumour cells) from liquid biopsies (fresh blood samples) in patients with advanced or metastatic soft tissue sarcomas.This study include collection of clinical data, of tumor samples (collected during standard of care).

EXPERIMENTAL PLAN One archival tumor sample (any FFPE and/or frozen tumor sample from surgery specimen or biopsy) will be collected. 1. A supplementary blood sample (2\*10 mL EDTA) will be also collected: blood sample will be collected before anthracyclin treatment initiation and during a standart sample performed after validation of inclusion. 2. Biological analyses will be initiated once inclusion has been confirmed (See Section 6.4) 3. A supplementary blood sample (2\*10 mL EDTA) will be also collected: blood sample will be collected before each chemotherapy administration and during a standart sample. 4. A supplementary blood sample (2\*10 mL EDTA) will be also collected: blood sample will be collected at each disease progression and during a standart sample. 5. In case of disease progression and if a biopsy is required for the management of the patient, a tumor sample will be collected (if patient agreed and if pathological material is the sufficient). 6. Clinical data will be collected into the study eCRF. Medical FU include visits at each chemotheapy administration, and disease assessment A total of 100 patients will be enrolled. Considering the nature of this trial, the sample size was defined in an empirical manner considering that over the 36-month enrollment period, 100 patients could be enrolled. The percentage of patients with detectable CTC (primary criterion) will be given with its associateed 95% confidence interval. For the seondary criteria, qualitative variables will be described using frequency and percentage distributions. The number of missing data will be given, but will not be considered for the calculation of proportions. Quantitative data will be described using the number of observations, mean, standard deviation, median, minimum and maximum values. Patient characteristics and other baseline data (demographics, disease characteristics) will be summarized. All data analyses will be performed using the SAS version 9.4 statistical software

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

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