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

NCT ID: NCT04512495

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2021-12-02

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with sarcoma

Group Type OTHER

Blood samples will be collected at two times :

Intervention Type OTHER

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

Interventions

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Blood samples will be collected at two times :

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
2. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
3. Age ≥ 18 years old.
4. Localized or metastatic disease or recurrent disease.
5. Patient who has not yet initiated specific treatment for sarcoma.
6. Patient affiliated to a Social Health Insurance in France.
7. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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20 SARC 04

Identifier Type: -

Identifier Source: org_study_id