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

Brief Title

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

Official Title

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

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.
    

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Leiomyosarcoma

Intervention

Blood samples will be collected at different times.

Study Arms / Comparison Groups

 Patient with leiomyosarcoma

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

20

Start Date

October 2022

Completion Date

July 2026

Primary Completion Date

July 2026

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).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 05 31 15 51 70, [email protected]

Location Countries

France

Location Countries

France

NCT ID

NCT05427461

Organization ID

22 SARC 03

Responsible Party

Sponsor

Study Sponsor

Institut Claudius Regaud

Collaborators

 Fondation ARC

Study Sponsor

, , 

Verification Date

August 2022