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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clinico-biological cohort | Other | A clinico-biological cohort with collection of tumor and blood sample for detecting and sorting circulating tumor cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of tumor and blood sample | Other | Collection of tumor and blood sample for detecting and sorting circulating tumor cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Percentage of patients with detectable CTC | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterise the genetic profile of CTCs | Transcriptomic data Genomic data Percentage of organoids formed Changes in CTC counts | 48 months |
| Establish tumour organoids from CTCs harvested before any initial treatment and, where possible, at the time of the first tumour recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehdi BRAHMI, MD | Contact | 0478 78 59 73 | +33 | mehdi.brahmi@lyon.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BRAHMI Mehdi | Lyon | 69008 | France |
|
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Transcriptomic data Genomic data Percentage of organoids formed Changes in CTC counts |
| 48 months |
| Correlate the clinical response to treatments with the in vitro efficacy of the same treatments on tumour organoids. | progression free survival according RECIST 1.1 criteria | 48 months |
| Assess the role of CTCs in tumour monitoring | progression free survival according RECIST 1.1 criteria | 48 months |
| Evaluate the mechanisms of resistance to chemotherapy | progression free survival according RECIST 1.1 criteria | 48 months |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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