Circulating  Cancer Cells / Macrophage  HYbrid Cells in Patients With Sarcoma, Part 2

Study Overview
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Brief Summary
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Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating cancer cell/macrophage hybrid cells in the peripheral blood and the evolution of this rate over time. The study will be conducted on a population of patients with leiomyosarcoma and treated in the context of routine care. 20 patients will be included: 10 patients with localized disease. 10 patients with metastatic disease. For each included patient, blood samples will be collected during baseline visit and up to 24 months after inclusion.

Official Title
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Circulating  Cancer Cells / Macrophage  HYbrid Cells in Patients With Sarcoma, Part 2

Conditions
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Leiomyosarcoma

Intervention / Treatment
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* Other: Blood samples will be collected at different times.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with leiomyosarcoma. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères) Localized or metastatic disease Newly diagnosed patient who has not yet initiated specific treatment for sarcoma Age ≥ 18 years Patient affiliated to a Social Security system in France. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures Exclusion Criteria: Diagnosis of any other histological subtype of soft tissue sarcoma Associated pathology(ies) that may interfere with the study procedure Pregnant or breastfeeding woman Any psychological, family, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures provided for in the study protocol. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient with leiomyosarcoma<br> | Other: Blood samples will be collected at different times.<br>* For patients with localized leiomyosarcoma, samples will be collected: At Baseline. Before surgery (for patients who have had neoadjuvant treatment (external radiotherapy and/or chemotherapy)). After surgery. At each control visit. At local or metastatic recurrence (or at 24 months post inclusion if no progression). For patients with metastatic leiomyosarcoma, samples will be collected: At Baseline. At each therapeutic line. At progression (or at 24 months post inclusion if no progression).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The longitudinal evolution of rate of patients with cancer cell / macrophage hybrid cells in peripheral blood. |  | 24 months after the end of inclusions. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood. |  | 24 months after the end of inclusions. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyosarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells