Improved Management of Soft Tissue Sarcomas Patients With an Optimized and Innovative Sorting Technology for Circulating Tumor Cells (LIGHT-CTC)

This trial is a monocentric, clinico-biological cohort study with prospective enrollment, aiming to develop a method for detecting and sorting CTCs (circulating tumour cells) from liquid biopsies (fresh blood samples) in patients with advanced or metastatic soft tissue sarcomas.This study include collection of clinical data, of tumor samples (collected during standard of care).

Study Overview

• Status: Not yet recruiting
• Conditions: Diagnosis of Soft Tissue Sarcoma (STS)
• Intervention / Treatment: Other: Collection of tumor and blood sample

Detailed Description

EXPERIMENTAL PLAN One archival tumor sample (any FFPE and/or frozen tumor sample from surgery specimen or biopsy) will be collected.

1. A supplementary blood sample (2*10 mL EDTA) will be also collected: blood sample will be collected before anthracyclin treatment initiation and during a standart sample performed after validation of inclusion.
2. Biological analyses will be initiated once inclusion has been confirmed (See Section 6.4)
3. A supplementary blood sample (2*10 mL EDTA) will be also collected: blood sample will be collected before each chemotherapy administration and during a standart sample.
4. A supplementary blood sample (2*10 mL EDTA) will be also collected: blood sample will be collected at each disease progression and during a standart sample.
5. In case of disease progression and if a biopsy is required for the management of the patient, a tumor sample will be collected (if patient agreed and if pathological material is the sufficient).
6. Clinical data will be collected into the study eCRF. Medical FU include visits at each chemotheapy administration, and disease assessment

A total of 100 patients will be enrolled.

Considering the nature of this trial, the sample size was defined in an empirical manner considering that over the 36-month enrollment period, 100 patients could be enrolled.

The percentage of patients with detectable CTC (primary criterion) will be given with its associateed 95% confidence interval. For the seondary criteria, qualitative variables will be described using frequency and percentage distributions. The number of missing data will be given, but will not be considered for the calculation of proportions. Quantitative data will be described using the number of observations, mean, standard deviation, median, minimum and maximum values.

Patient characteristics and other baseline data (demographics, disease characteristics) will be summarized.

All data analyses will be performed using the SAS version 9.4 statistical software

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehdi BRAHMI, MD; Phone Number: +33 0478 78 59 73; Email: mehdi.brahmi@lyon.unicancer.fr

Study Locations

• France
  • Lyon, France, 69008
    • BRAHMI Mehdi
    • Contact: Mehdi BRAHMI, MD; Phone Number: +33 04 78 78 59 73; Email: mehdi.brahmi@lyon.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female patients ≥ 18 years at the day of consenting;
• Histologically confirmed diagnosis of Soft Tissue Sarcoma (STS) excepted GIST.
• Metastatic disease or unresectable locally advanced malignancy for which standard therapy by anthracycline is decided;
• At least one measurable lesion as per RECIST version 1.1.;
• ECOG Performance Status of 0-2;
• Patients must have an adequate organ and bone marrow function at baseline;
• Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with procedures as per protocol;
• Covered by a medical insurance.

Exclusion Criteria:

• Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results;
• Prior treatment with anthracycline;
• History of other malignancy other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of disease for at least 3 years;
• Metabolic syndrome;
• Pregnant or breast-feeding woman criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: clinico-biological cohort; A clinico-biological cohort with collection of tumor and blood sample for detecting and sorting circulating tumor cells	Other: Collection of tumor and blood sample; Collection of tumor and blood sample for detecting and sorting circulating tumor cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To develop a method for detecting and sorting CTCs (circulating tumour cells) from liquid biopsies (fresh blood samples) in patients with advanced or metastatic soft tissue sarcomas	Percentage of patients with detectable CTC	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterise the genetic profile of CTCs	Transcriptomic data Genomic data Percentage of organoids formed Changes in CTC counts	48 months
Establish tumour organoids from CTCs harvested before any initial treatment and, where possible, at the time of the first tumour recurrence	Transcriptomic data Genomic data Percentage of organoids formed Changes in CTC counts	48 months
Correlate the clinical response to treatments with the in vitro efficacy of the same treatments on tumour organoids.	progression free survival according RECIST 1.1 criteria	48 months
Assess the role of CTCs in tumour monitoring	progression free survival according RECIST 1.1 criteria	48 months
Evaluate the mechanisms of resistance to chemotherapy	progression free survival according RECIST 1.1 criteria	48 months

Collaborators and Investigators

• Sponsor: Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Oncology; Soft tissue sarcoma; CTC
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms; Sarcoma; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: ET25-243 (LIGHT-CTC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No