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

NCT ID: NCT05427461

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-13
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with leiomyosarcoma

Group Type: OTHER

Blood samples will be collected at different times.

Intervention Type: 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).

Interventions

Blood 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).

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation ARC

OTHER

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, , France

Countries

France

Other Identifiers

22 SARC 03

Identifier Type: -

Identifier Source: org_study_id