Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?

NCT04512495 | Completed

• 1 other identifier: 20 SARC 04
• Study Type: interventional
• Target: 60
• 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. The study will be conducted on a population of patients with sarcoma and treated in the context of routine care. For each included patient, blood samples will be collected during baseline visit and after the initiation therapy. At the end of the 2nd blood collection, the patient will have completed his participation in the study.

Conditions

Sarcoma

Keywords

Leiomyosarcoma; Dedifferentiated liposarcoma; Myxoid liposarcoma; Synovialosarcoma; Osteosarcoma; Ewing's sarcoma; Cancer cell/macrophage hybrid cells; Hybrid cells

Outcome Measures

Primary Outcomes (1)

• Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.

  6 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.

  6 months after the end of inclusions

Study Arms (1)

Patients with sarcoma

OTHER

Other: Blood samples will be collected at two times :

Interventions

Blood samples will be collected at two times : OTHER

* at Baseline, * after surgery or at the time of post-chemotherapy evaluation.

Patients with sarcoma

Eligibility Criteria

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

You may qualify if:

• Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
• Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
• Age ≥ 18 years old.
• Localized or metastatic disease or recurrent disease.
• Patient who has not yet initiated specific treatment for sarcoma.
• Patient affiliated to a Social Health Insurance in France.

You may not qualify if:

• Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.
• Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.
• Pregnant or breastfeeding woman.
• Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of 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

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Sarcoma; Leiomyosarcoma; Liposarcoma; Liposarcoma, Myxoid; Sarcoma, Synovial; Osteosarcoma; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Neoplasms, Connective Tissue; Neoplasms, Bone Tissue

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: August 7, 2020
• First Posted: August 13, 2020
• Study Start: October 22, 2020
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

FR (1)