Genetic Signature in Development of SarcomasPREDISARCNCT03625791
Validation of a Genetic Signature to Predict the Development of Sarcomas
An observational study of Genetic Signature in Development of Sarcomas, run by Centre Georges Francois Leclerc at 3 sites in France.
Trial summary
The aim of the SARI study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. This study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Signature in Development of Sarcomas
- What is being tested?
- blood sample
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Jun 2018to 19 Jun 2022
- 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: * Group 1: 20 patients with sarcoma developed in irradiated territory * Group 2: 20 patients treated for cancer by radiotherapy for more than 5 years and who have not developed sarcoma * Group 3: 20 patients with primary sarcoma
Who may be able to join
- Major patient at the time of initial radiotherapy or diagnosis of primary sarcoma.
- Patient belonging to one of these 3 groups :
- Group 1: Patient treated with radiotherapy for cancer other than primary sarcoma and who developed sarcoma (other than osteosarcoma) in the irradiated area.
- OR Group 2: Patient who received radiotherapy for more than 5 years and did not develop sarcoma or other secondary cancers OR Group 3: Patient who developed primary sarcoma and who had never been treated with radiotherapy
- Patient who have signed informed consent to participate in the study.
- Affiliation to the social security system.
Who cannot join
- Patient unable to understand, read and / or sign informed consent.
- Person benefiting from a protection system for adults (including guardianship and trusteeship)
- Pregnant or lactating woman.
- Patient who participated in the SARI study "Predictive study of sarcomas developed in irradiated territory from the GSF-GETO database (ID-RCB no .: 2011-A01102-39)"
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institu Bergonie
Bordeaux, 33076
Centre Georges François Leclerc
Dijon, 21000
Institut Gustave Roussy
Villejuif, 94805
About this study
The aim of the SARI study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. This study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma.
Following the sequencing of the exomes of all these patients, the SARI study made it possible to highlight a genetic signature from 11 genes, predictive of the appearance of a sarcoma after a first radiotherapy. This signature is the subject of a patent (BFF 170286 / VF, filed on June 22, 2017). A final validation step with samples that have not been used to optimize this signature is now required. Moreover, it is now necessary to validate if this signature is specific to the predisposition to the development of radiation-induced sarcomas only or if this signature is also valid for the predisposition to the development of all sarcomas, even primary ones.
The objective of the PREDISARC study is to evaluate the specificity of this genetic signature (11 genes) with the appearance of sarcomas in irradiated territory compared to a population without sarcoma that has been treated with radiotherapy.
Read the detailed description
A total of 60 patients will be included in this pilot study:
- Group 1: 20 patients with induced radio sarcoma
- Group 2: 20 patients without primary sarcoma or induced radio sarcoma
- Group 3: 20 patients with primary sarcoma These numbers will make it possible to have preliminary data making it possible to judge the interest of the genetic signature in the prediction of the radiation-induced sarcomas.
- Being tested
- blood sample
- Keywords
- sarcoma, genetic
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
1 tube with 4 ml of blood per patient
| Study group | Role | What they receive |
|---|---|---|
| radiation-induced sarcomas | Not described Receives: Biological: blood sample | |
| radiotherapy for at least 5 years and without sarcomas | Not described Receives: Biological: blood sample | |
| primary sarcomas | Not described Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA
Bioinformatic analyzes will be realized out blindly on the 11 genes of the signature to validate determining the group of belonging of the patients
Measured: at the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start19 Jun 2018
- Primary completion19 Jun 2022
- Study completion19 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic Signature in Development of SarcomasStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles TRUC, Principal investigator, CGFL, Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625791
- Sponsor's protocol ID
- PREDISARC
- Acronym
- PREDISARC
- Status last verified
- Feb 2024
- First submitted
- 8 Aug 2018
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Genetic Signature to Predict the Development of Sarcomas
- ClinicalTrials.gov ID
- NCT03625791
- Acronym / sponsor ID
- PREDISARC / PREDISARC
- Keywords
- sarcoma, genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 19 Jun 2022 (actual)
- Study completion
- 19 Jun 2022 (actual)
- First posted
- 10 Aug 2018 (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.
The aim of the SARI study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. This study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma.
Following the sequencing of the exomes of all these patients, the SARI study made it possible to highlight a genetic signature from 11 genes, predictive of the appearance of a sarcoma after a first radiotherapy. This signature is the subject of a patent (BFF 170286 / VF, filed on June 22, 2017). A final validation step with samples that have not been used to optimize this signature is now required. Moreover, it is now necessary to validate if this signature is specific to the predisposition to the development of radiation-induced sarcomas only or if this signature is also valid for the predisposition to the development of all sarcomas, even primary ones.
The objective of the PREDISARC study is to evaluate the specificity of this genetic signature (11 genes) with the appearance of sarcomas in irradiated territory compared to a population without sarcoma that has been treated with radiotherapy.
Detailed description
A total of 60 patients will be included in this pilot study:
- Group 1: 20 patients with induced radio sarcoma
- Group 2: 20 patients without primary sarcoma or induced radio sarcoma
- Group 3: 20 patients with primary sarcoma These numbers will make it possible to have preliminary data making it possible to judge the interest of the genetic signature in the prediction of the radiation-induced sarcomas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| radiation-induced sarcomas | – | Biological: blood sample |
| radiotherapy for at least 5 years and without sarcomas | – | Biological: blood sample |
| primary sarcomas | – | Biological: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Group 1: 20 patients with sarcoma developed in irradiated territory * Group 2: 20 patients treated for cancer by radiotherapy for more than 5 years and who have not developed sarcoma * Group 3: 20 patients with primary sarcoma
Key inclusion criteria (6 listed)
- Major patient at the time of initial radiotherapy or diagnosis of primary sarcoma.
- Patient belonging to one of these 3 groups :
- Group 1: Patient treated with radiotherapy for cancer other than primary sarcoma and who developed sarcoma (other than osteosarcoma) in the irradiated area.
- OR Group 2: Patient who received radiotherapy for more than 5 years and did not develop sarcoma or other secondary cancers OR Group 3: Patient who developed primary sarcoma and who had never been treated with radiotherapy
- Patient who have signed informed consent to participate in the study.
Key exclusion criteria (4 listed)
- Patient unable to understand, read and / or sign informed consent.
- Person benefiting from a protection system for adults (including guardianship and trusteeship)
- Pregnant or lactating woman.
- Patient who participated in the SARI study "Predictive study of sarcomas developed in irradiated territory from the GSF-GETO database (ID-RCB no .: 2011-A01102-39)"
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 |
|---|---|---|
| blood sample1 tube with 4 ml of blood per patient | Biological | primary sarcomas, radiation-induced sarcomas, radiotherapy for at least 5 years and without sarcomas |
Primary outcome
DNA
Time frame: at the inclusion
Bioinformatic analyzes will be realized out blindly on the 11 genes of the signature to validate determining the group of belonging of the patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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.
Gilles TRUC principal investigator
CGFL, Dijon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Signature in Development of Sarcomas, run by Centre Georges Francois Leclerc at 3 sites 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 4 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: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA (time frame: at the inclusion). 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 13 Feb 2024.