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Completed

NCT Number: NCT04512495

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

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.

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Key information

Conditions

Sarcoma Leiomyosarcoma Liposarcoma Liposarcoma, Myxoid Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Osteosarcoma Sarcoma, Ewing Sarcoma, Synovial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion criteria

  • 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).

Treatment and study plan

Blood samples will be collected at two times :

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

Primary outcomes

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

    Time frame: 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.

    Time frame: 6 months after the end of inclusions

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: SAMHY SARCOME

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2020
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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