Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2 (SAMHY2)

May 28, 2025 updated by: Institut Claudius Regaud

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient with leiomyosarcoma
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
24 months after the end of inclusions.

Secondary Outcome Measures

Outcome 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.
Time Frame: 24 months after the end of inclusions.
24 months after the end of inclusions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Collaborators

Fondation ARC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22 SARC 03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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