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OpenTrials
Active, Not Recruiting

NCT Number: NCT05427461

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Leiomyosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer 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 leiomyosarcoma.
  • Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
  • Localized or metastatic disease
  • Newly diagnosed patient who has not yet initiated specific treatment for sarcoma
  • Age ≥ 18 years
  • Patient affiliated to a Social Security system in France.
  • Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures

Exclusion criteria

  • Diagnosis of any other histological subtype of soft tissue sarcoma
  • Associated pathology(ies) that may interfere with the study procedure
  • Pregnant or breastfeeding woman
  • 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.
  • 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 different times.

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).

Primary outcomes

  1. 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.

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: 24 months after the end of inclusions.

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Fondation ARC

Registry information

Acronym: SAMHY2

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2022
Registry last updated
Jun 3, 2025

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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