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Not yet recruitingNCT07401355LIGHT-CTCUpdated Feb 10, 2026

Improved Management of Soft Tissue Sarcomas Patients With an Optimized and Innovative Sorting Technology for Circulating Tumor Cells

An interventional study of Collection of tumor and blood sample in Diagnosis of Soft Tissue Sarcoma (STS), sponsored by Centre Leon Berard. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Centre Leon Berard · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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

02

Conditions studied

  • Diagnosis of Soft Tissue Sarcoma (STS)

Keywords

  • Oncology
  • Soft tissue sarcoma
  • CTC
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • OtherCollection of tumor and blood sample

    Collection of tumor and blood sample for detecting and sorting circulating tumor cells

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 48 months

Secondary outcomes

  1. Characterise the genetic profile of CTCs

    Transcriptomic data Genomic data Percentage of organoids formed Changes in CTC counts

    Time frame: 48 months

  2. 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

    Time frame: 48 months

  3. 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

    Time frame: 48 months

  4. Assess the role of CTCs in tumour monitoring

    progression free survival according RECIST 1.1 criteria

    Time frame: 48 months

  5. Evaluate the mechanisms of resistance to chemotherapy

    progression free survival according RECIST 1.1 criteria

    Time frame: 48 months

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07401355
Lead sponsor
Centre Leon Berard
Responsible party
Sponsor
First posted
Feb 10, 2026
Start date
Mar 2026 (estimated)
Primary completion
Jan 2030 (estimated)
Completion
Jan 2030 (estimated)
Last update
Feb 10, 2026

Study contacts

Mehdi BRAHMI, MD
Contact
mehdi.brahmi@lyon.unicancer.fr
0478 78 59 73 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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