Leiomyosarcoma
Conditions
Keywords
Leiomyosarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells
Brief summary
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.
Interventions
OTHERBlood samples will be collected at different times.
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).
Sponsors
Fondation ARC
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with leiomyosarcoma. 2. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères) 3. Localized or metastatic disease 4. Newly diagnosed patient who has not yet initiated specific treatment for sarcoma 5. Age ≥ 18 years 6. Patient affiliated to a Social Security system in France. 7. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures
Exclusion criteria
1. Diagnosis of any other histological subtype of soft tissue sarcoma 2. Associated pathology(ies) that may interfere with the study procedure 3. Pregnant or breastfeeding woman 4. 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. 5. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
France
Outcome results
None listed