Soft Tissue SarcomasRADIOSARCNCT05739084
Gene Signatures Searching of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Patients With Resectable STS
An observational study of Soft Tissue Sarcomas, run by Centre Leon Berard at 1 site in France.
Trial summary
To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcomas
- What is being tested?
- pre-operative radiation and Standard surgery after rpreoprative radiation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2022to 23 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with Soft tissus sarcoma who underwent/undergo to preoperative Radiation and for whom resected tumour specimen is available.
Who may be able to join
- Male and female ≥ 18 years at time of non-opposition to participate to the study
- Patient with documented non-opposition to participate to the study.
- Patient with histologically and cytologically confirmed diagnosis with STS (..)
- Patient with availability of FFPE tumor block from initial diagnosis biopsy (mandatory) and surgery specimen (optional).
- Patients with tumor FFPE samples prepared with the last 4 years
- Patient with evaluable tumor sample meeting the following quality/quantity control criteria (..)
Who cannot join
- Patients with metastatic soft tissue sarcoma at diagnosis
- Patients with exclusive radiotherapy without surgical resection
- Patients receiving neo adjuvant systemic treatment (chemotherapy, immunotherapy, targeted therapy)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Léon Bérard
Lyon
Marie-Pierre SUNYACH, MD, +33 (0)4 78 78 28 28, MariePierre.SUNYACH@lyon.unicancer.fr
Waisse Waissi, MD, +33 (0)4 78 78 28 28, Waisse.WAISSI@lyon.unicancer.fr
About this study
Official title: [RADIOSARC] Searching for Specific Gene Signature(s) of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Adults Patients With Resectable Soft Tissue Sarcomas of Limbs
To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Our proposal is to conduct a cohort study aiming at identifying transcriptomic biomarkers predictive of sensitivity and/or resistance to RT in limbs STS patients
Read the detailed description
Whether RT should be performed pre or post-operatively is still a debated question. To date, the radiation oncologist are missing signature of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Therefore, predicting the likelihood of response/resistance to RT is essential. The individual exploration with high-throughput approaches will participate in describing biological mechanisms involved in STS tumor cell pan-resistance, thus identifying potential molecular targets that could be inhibited to reverse intrinsic radioresistance. In this context, our proposal is to conduct a cohort study aiming at identifying transcriptomic signature predictive of sensitivity and/or resistance to RT in limbs STS patients.
- Conditions
- Soft Tissue Sarcomas
- Being tested
- pre-operative radiation, Standard surgery after rpreoprative radiation
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative radiationRadiation
As per standard of care and institutional guidelines
Standard surgery after rpreoprative radiationProcedure or surgery
As per standard of care and institutional guidelines
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | A total sample size of 200 patients is expected in the retrospective thanks to the NETSARC/ CONTICABASE databases (French sarcoma reference network) Receives: Radiation: pre-operative radiation; Procedure: Standard surgery after rpreoprative radiation | |
| Prospective cohort | To ensure an external validation, patients from NETsarc centers experiencing preoperative RT will be prospectively accrued and transcriptomic signature will be tested.
Up to 100 patients will be enrolled in this prospective cohort. Receives: Radiation: pre-operative radiation; Procedure: Standard surgery after rpreoprative radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define a transcriptomic signature of histological response to radiotherapy in STS patients using the percentage of residual viable cells as a clinical meaningful endpoint
Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response.
Measured: 36 months
Secondary outcomes (1)
To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints
Gene expression signature using RNAseq correlated to the percentage of necrosis, the percentage of fibrosis, the local control at 1 and 2 years (1- and 2-year local / distant recurrence-free survival, the time To Relapse (TTR), the Disease Free Survival (DFS), The Quality of resection level based on the residual tumor (R) classification.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start23 Nov 2022
- Primary completion23 Jun 2025 (estimated)
- Study completion23 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 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
- NCT05739084
- Sponsor's protocol ID
- ET21-240 [RADIOSARC]
- Other IDs
- GDPR registration Number
- Acronym
- RADIOSARC
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [RADIOSARC] Searching for Specific Gene Signature(s) of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Adults Patients With Resectable Soft Tissue Sarcomas of Limbs
- ClinicalTrials.gov ID
- NCT05739084
- Acronym / sponsor ID
- RADIOSARC / ET21-240 [RADIOSARC]
- Conditions
- Soft Tissue Sarcomas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 23 Jun 2025 (estimated)
- Study completion
- 23 Nov 2025 (estimated)
- First posted
- 22 Feb 2023 (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.
To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Our proposal is to conduct a cohort study aiming at identifying transcriptomic biomarkers predictive of sensitivity and/or resistance to RT in limbs STS patients
Detailed description
Whether RT should be performed pre or post-operatively is still a debated question. To date, the radiation oncologist are missing signature of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Therefore, predicting the likelihood of response/resistance to RT is essential. The individual exploration with high-throughput approaches will participate in describing biological mechanisms involved in STS tumor cell pan-resistance, thus identifying potential molecular targets that could be inhibited to reverse intrinsic radioresistance. In this context, our proposal is to conduct a cohort study aiming at identifying transcriptomic signature predictive of sensitivity and/or resistance to RT in limbs STS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Radiation: pre-operative radiation, Procedure: Standard surgery after rpreoprative radiationA total sample size of 200 patients is expected in the retrospective thanks to the NETSARC/ CONTICABASE databases (French sarcoma reference network) |
| Prospective cohort | – | Radiation: pre-operative radiation, Procedure: Standard surgery after rpreoprative radiationTo ensure an external validation, patients from NETsarc centers experiencing preoperative RT will be prospectively accrued and transcriptomic signature will be tested. Up to 100 patients will be enrolled in this prospective cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Soft tissus sarcoma who underwent/undergo to preoperative Radiation and for whom resected tumour specimen is available.
Key inclusion criteria (6 listed)
- Male and female ≥ 18 years at time of non-opposition to participate to the study
- Patient with documented non-opposition to participate to the study.
- Patient with histologically and cytologically confirmed diagnosis with STS (..)
- Patient with availability of FFPE tumor block from initial diagnosis biopsy (mandatory) and surgery specimen (optional).
- Patients with tumor FFPE samples prepared with the last 4 years
Key exclusion criteria (3 listed)
- Patients with metastatic soft tissue sarcoma at diagnosis
- Patients with exclusive radiotherapy without surgical resection
- Patients receiving neo adjuvant systemic treatment (chemotherapy, immunotherapy, targeted therapy)
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 |
|---|---|---|
| pre-operative radiationAs per standard of care and institutional guidelines | Radiation | Prospective cohort, Retrospective cohort |
| Standard surgery after rpreoprative radiationAs per standard of care and institutional guidelines | Procedure or surgery | Prospective cohort, Retrospective cohort |
Primary outcome
To define a transcriptomic signature of histological response to radiotherapy in STS patients using the percentage of residual viable cells as a clinical meaningful endpoint
Time frame: 36 months
Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response.
1 secondary outcome
To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcomas, 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie -Pierre SUNYACH, MD (+33(0)4 78 78 28 28, MariePierre.SUNYACH@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define a transcriptomic signature of histological response to radiotherapy in STS patients using the percentage of residual viable cells as a clinical meaningful endpoint (time frame: 36 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 22 Feb 2023.