SarcomaBCB-SarcomesNCT03978039
National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group
An observational study of Sarcoma, run by Institut Bergonié at 3 sites in France.
Trial summary
The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas [RESOS] / French expert network dedicated to the pathology of sarcomas… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- Chemotherapy, Immunotherapeutic Agent and target treatment
- Type of treatment
- Surgery or procedure
- How many people
- 150,000 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jan 2010to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diagnosis of sarcoma
Who may be able to join
- Diagnosis of sarcoma
- Diagnosis in a French Comprehensive Cancer Center
- Any age
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Institut Bergonié, Comprehensive Cancer Center
Bordeaux
Maud Toulmonde, MD
Antoine Italiano, MD/PhD
- Recruiting
Centre Léon Bérard
Lyon
Jean-Yves Blay, MD/PhD
- Recruiting
Institut Gustave Roussy, Comprehensive Cancer Center
Villejuif
Axel Le Cesne, MD/PhD
About this study
Official title: The "BCB-sarcomes" Database: the Database of the French Sarcoma Group Dedicated to the Collection of Clinical and Biological Data for All Sarcomas
The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas [RESOS] / French expert network dedicated to the pathology of sarcomas [RREPS]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas [NETSARC]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples.
Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes.
With the financial support of the French National Cancer Institute [Institut National du cancer [INCa]).
- Conditions
- Sarcoma
- Being tested
- Chemotherapy, Immunotherapeutic Agent, target treatment, Surgery, Radiotherapy
- Keywords
- patterns of care, access to care, survival, experts' network
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
treatment as per standard of care
Immunotherapeutic AgentDrug
treatment as per standard of care
target treatmentDrug
treatment as per standard of care
SurgeryProcedure or surgery
treatment as per standard of care
RadiotherapyRadiation
treatment as per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Patients with sarcoma | Patients with a sarcoma diagnosed in a French Comprehensive cancer Center Receives: Drug: Chemotherapy; Drug: Immunotherapeutic Agent; Drug: target treatment; Procedure: Surgery; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to next treatment (TNT)
Time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first. When neither death nor new systemic therapy is observed, TNT is censored at the date of last patient contact.
Measured: 2 years
Time to next treatment (TNT)
Time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first. When neither death nor new systemic therapy is observed, TNT is censored at the date of last patient contact.
Measured: 5 years
Overall survival (OS)
Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.
Measured: 2 years
Overall survival (OS)
Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jan 2010
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- 150,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- French Sarcoma Group
- Responsible party
- Sponsor
- Investigators
- Maud Toulmonde, MD, Study chair, Institut Bergonié, Bordeaux, FranceAxel Le Cesne, MD/PhD, Study chair, Institut Gustave Roussy, Villejuif, FranceJean-Yves Blay, MD/PhD, Study chair, Centre Léon Bérard, Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978039
- Sponsor's protocol ID
- IB2012-BCB-SARCOMES
- Acronym
- BCB-Sarcomes
- Status last verified
- Aug 2025
- First submitted
- 5 Jun 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.
PubMed 28391775Toulmonde M, Bonvalot S, Meeus P, Stoeckle E, Riou O, Isambert N, Bompas E, Jafari M, Delcambre-Lair C, Saada E, Le Cesne A, Le Pechoux C, Blay JY, Piperno-Neumann S, Chevreau C, Bay JO, Brouste V, Terrier P, Ranchere-Vince D, Neuville A, Italiano A; French Sarcoma Group. Retroperitoneal sarcomas: patterns of care at diagnosis, prognostic factors and focus on main histological subtypes: a multicenter analysis of the French Sarcoma Group. Ann Oncol. 2014 Mar;25(3):735-742. doi: 10.1093/annonc/mdt577.
PubMed 24567518Blay JY, Soibinet P, Penel N, Bompas E, Duffaud F, Stoeckle E, Mir O, Adam J, Chevreau C, Bonvalot S, Rios M, Kerbrat P, Cupissol D, Anract P, Gouin F, Kurtz JE, Lebbe C, Isambert N, Bertucci F, Toumonde M, Thyss A, Piperno-Neumann S, Dubray-Longeras P, Meeus P, Ducimetiere F, Giraud A, Coindre JM, Ray-Coquard I, Italiano A, Le Cesne A. Improved survival using specialized multidisciplinary board in sarcoma patients. Ann Oncol. 2017 Nov 1;28(11):2852-2859. doi: 10.1093/annonc/mdx484.
PubMed 29117335
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "BCB-sarcomes" Database: the Database of the French Sarcoma Group Dedicated to the Collection of Clinical and Biological Data for All Sarcomas
- ClinicalTrials.gov ID
- NCT03978039
- Acronym / sponsor ID
- BCB-Sarcomes / IB2012-BCB-SARCOMES
- Conditions
- Sarcoma
- Keywords
- patterns of care, access to care, survival, experts' network
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- French Sarcoma Group
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 6 Jun 2019 (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 BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas [RESOS] / French expert network dedicated to the pathology of sarcomas [RREPS]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas [NETSARC]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples.
Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes.
With the financial support of the French National Cancer Institute [Institut National du cancer [INCa]).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with sarcoma | – | Drug: Chemotherapy, Drug: Immunotherapeutic Agent, Drug: target treatment, Procedure: Surgery, Radiation: RadiotherapyPatients with a sarcoma diagnosed in a French Comprehensive cancer Center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosis of sarcoma
Key inclusion criteria (3 listed)
- Diagnosis of sarcoma
- Diagnosis in a French Comprehensive Cancer Center
- Any age
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Chemotherapytreatment as per standard of care | Drug | Patients with sarcoma |
| Immunotherapeutic Agenttreatment as per standard of care | Drug | Patients with sarcoma |
| target treatmenttreatment as per standard of care | Drug | Patients with sarcoma |
| Surgerytreatment as per standard of care | Procedure or surgery | Patients with sarcoma |
| Radiotherapytreatment as per standard of care | Radiation | Patients with sarcoma |
Primary outcome
Time to next treatment (TNT)
Time frame: 2 years
Time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first. When neither death nor new systemic therapy is observed, TNT is censored at the date of last patient contact.
Time to next treatment (TNT)
Time frame: 5 years
Time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first. When neither death nor new systemic therapy is observed, TNT is censored at the date of last patient contact.
Overall survival (OS)
Time frame: 2 years
Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.
Overall survival (OS)
Time frame: 5 years
Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.
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 4 Sep 2025.
- Results publication: PubMed 28391775Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.
- Results publication: PubMed 24567518Toulmonde M, Bonvalot S, Meeus P, Stoeckle E, Riou O, Isambert N, Bompas E, Jafari M, Delcambre-Lair C, Saada E, Le Cesne A, Le Pechoux C, Blay JY, Piperno-Neumann S, Chevreau C, Bay JO, Brouste V, Terrier P, Ranchere-Vince D, Neuville A, Italiano A; French Sarcoma Group. Retroperitoneal sarcomas: patterns of care at diagnosis, prognostic factors and focus on main histological subtypes: a multicenter analysis of the French Sarcoma Group. Ann Oncol. 2014 Mar;25(3):735-742. doi: 10.1093/annonc/mdt577.
- Results publication: PubMed 29117335Blay JY, Soibinet P, Penel N, Bompas E, Duffaud F, Stoeckle E, Mir O, Adam J, Chevreau C, Bonvalot S, Rios M, Kerbrat P, Cupissol D, Anract P, Gouin F, Kurtz JE, Lebbe C, Isambert N, Bertucci F, Toumonde M, Thyss A, Piperno-Neumann S, Dubray-Longeras P, Meeus P, Ducimetiere F, Giraud A, Coindre JM, Ray-Coquard I, Italiano A, Le Cesne A. Improved survival using specialized multidisciplinary board in sarcoma patients. Ann Oncol. 2017 Nov 1;28(11):2852-2859. doi: 10.1093/annonc/mdx484.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Maud Toulmonde, MD study chair
Institut Bergonié, Bordeaux, France
Axel Le Cesne, MD/PhD study chair
Institut Gustave Roussy, Villejuif, France
Jean-Yves Blay, MD/PhD study chair
Centre Léon Bérard, Lyon, France
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 Sarcoma, run by Institut Bergonié 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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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?
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 Maud Toulmonde, MD (0556333333, m.toulmonde@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to next treatment (TNT) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978039, which also lists 3 linked publications.
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 4 Sep 2025.