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

Not Applicable

Recruiting

• Conditions: Leiomyosarcoma
• Interventions: Other: Blood samples will be collected at different times.

• Registration Number: NCT05427461
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Study Start: 2023-01-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with leiomyosarcoma	Blood samples will be collected at different times.	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Institut Universitaire du Cancer Toulouse - Oncopole; 🇫🇷 Toulouse, France