Evaluating hybrid cancer cells in patients with leiomyosarcoma
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2
This study is testing whether certain hybrid cancer cells are present in the blood of patients with leiomyosarcoma to see how they change over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05427461 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the presence of circulating 'cancer cell/macrophage' hybrid cells in the blood of patients diagnosed with leiomyosarcoma. It will involve 20 patients, split evenly between those with localized and metastatic disease, who will provide blood samples at baseline and over a 24-month period. The study is designed to monitor changes in the rate of these hybrid cells over time as part of routine care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histologically confirmed diagnosis of leiomyosarcoma who have not yet started specific treatment.
Not a fit: Patients with other histological subtypes of soft tissue sarcoma or those with conditions that interfere with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of leiomyosarcoma progression and potentially lead to new diagnostic or therapeutic strategies.
How similar studies have performed: While the approach of evaluating hybrid cells is novel, similar studies have shown promise in understanding cancer cell behavior and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Toulouse
- Institut Universitaire du Cancer Toulouse - Oncopole — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Thibaud VALENTIN
- Email: valentin.thibaud@iuct-oncopole.fr
- Phone: 05 31 15 51 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.