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

NCT05427461 | Active Not Recruiting

• 1 other identifier: 22 SARC 03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyosarcoma

Keywords

Leiomyosarcoma; Cancer cell/macrophage hybrid cells; Hybrid cells

Outcome Measures

Primary Outcomes (1)

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

  24 months after the end of inclusions.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Patient with leiomyosarcoma

OTHER

Other: Blood samples will be collected at different times.

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).

Patient with leiomyosarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Fondation ARC: collaborator

Study Sites (1)

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Leiomyosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: January 13, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

FR (1)