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

N/AActive Not RecruitingNCT05427461

Institut Claudius Regaud20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Leiomyosarcoma

Interventions

Blood samples will be collected at different times.OTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, France

Outcomes

Primary Outcomes

The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.

Time frame: 24 months after the end of inclusions.

Secondary Outcomes

Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.

Time frame: 24 months after the end of inclusions.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.