Diagnosis of Soft Tissue Sarcoma (STS)LIGHT-CTCNCT07401355
Improved Management of Soft Tissue Sarcomas Patients With an Optimized and Innovative Sorting Technology for Circulating Tumor Cells
A study testing Collection of tumor and blood sample in people with Diagnosis of Soft Tissue Sarcoma (STS), run by Centre Leon Berard at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis of Soft Tissue Sarcoma (STS)
- What is being tested?
- Collection of tumor and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
BRAHMI Mehdi
Lyon, 69008
Mehdi BRAHMI, MD, 04 78 78 59 73 ext. +33, mehdi.brahmi@lyon.unicancer.fr
About this study
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.
- 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.
- Biological analyses will be initiated once inclusion has been confirmed (See Section 6.4)
- 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.
- 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.
- 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).
- 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
- Conditions
- Diagnosis of Soft Tissue Sarcoma (STS)
- Being tested
- Collection of tumor and blood sample
- Keywords
- Oncology, Soft tissue sarcoma, CTC
- Medical subject headings
- Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of tumor and blood sampleOther
Collection of tumor and blood sample for detecting and sorting circulating tumor cells
| Study group | Role | What they receive |
|---|---|---|
| clinico-biological cohort | Other | A clinico-biological cohort with collection of tumor and blood sample for detecting and sorting circulating tumor cells Receives: Other: Collection of tumor and blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 months
Secondary outcomes (5)
Characterise the genetic profile of CTCs
Transcriptomic data Genomic data Percentage of organoids formed Changes in CTC counts
Measured: 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
Measured: 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
Measured: 48 months
Assess the role of CTCs in tumour monitoring
progression free survival according RECIST 1.1 criteria
Measured: 48 months
Evaluate the mechanisms of resistance to chemotherapy
progression free survival according RECIST 1.1 criteria
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis of Soft Tissue Sarcoma (STS)Studies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401355
- Sponsor's protocol ID
- ET25-243 (LIGHT-CTC)
- Acronym
- LIGHT-CTC
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Management of Soft Tissue Sarcomas Patients With an Optimized and Innovative Sorting Technology for Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT07401355
- Acronym / sponsor ID
- LIGHT-CTC / ET25-243 (LIGHT-CTC)
- Conditions
- Diagnosis of Soft Tissue Sarcoma (STS)
- Keywords
- Oncology, Soft tissue sarcoma, CTC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
EXPERIMENTAL PLAN One archival tumor sample (any FFPE and/or frozen tumor sample from surgery specimen or biopsy) will be collected.
- 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.
- Biological analyses will be initiated once inclusion has been confirmed (See Section 6.4)
- 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.
- 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.
- 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).
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinico-biological cohort | Other | Other: Collection of tumor and blood sampleA clinico-biological cohort with collection of tumor and blood sample for detecting and sorting circulating tumor cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of tumor and blood sampleCollection of tumor and blood sample for detecting and sorting circulating tumor cells | Other | clinico-biological cohort |
Primary outcome
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
Time frame: 48 months
Percentage of patients with detectable CTC
5 secondary outcomes
Characterise the genetic profile of CTCs
Time frame: 48 months
Establish tumour organoids from CTCs harvested before any initial treatment and, where possible, at the time of the first tumour recurrence
Time frame: 48 months
Correlate the clinical response to treatments with the in vitro efficacy of the same treatments on tumour organoids.
Time frame: 48 months
Assess the role of CTCs in tumour monitoring
Time frame: 48 months
Evaluate the mechanisms of resistance to chemotherapy
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of tumor and blood sample in people with Diagnosis of Soft Tissue Sarcoma (STS), run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehdi BRAHMI, MD (0478 78 59 73 ext. +33, mehdi.brahmi@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.