Solid Tumor, Unspecified, AdultSTINGNCT04932525
Gustave Roussy Cancer Profiling
A study testing Biopsy in people with Solid Tumor, Unspecified, Adult, run by Gustave Roussy, Cancer Campus, Grand Paris at 4 sites in France.
Trial summary
The objective of STING study is to perform high throughput molecular analysis (next generation sequencing +/- immunological profiling) to estimate the proportion of patients with cancer presenting at least one targetable genomic alteration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Unspecified, Adult
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 4 sitesFrance
- Study dates
- 10 May 2021to 10 May 2033
- 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
- Age ≥ 18 years
- Histology: solid malignant tumor or hematological malignancy.
- Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
- Voluntary signed and dated written informed consent prior to any study specific procedure.
Who cannot join
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Pregnant or breast-feeding women
- Minors (Age < 18 years)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Hôpital Marie-Lannelongue
Le Plessis-Robinson, 92350
Olaf MERCIER, Pr, olaf.mercier@universite-paris-saclay.fr
- Not yet recruiting
Hôpital Saint-Joseph
Paris, 75014
Charles NALTET, Dr, 01 44 12 37 52, cnaltet@ghpsj.fr
- Not yet recruiting
Hôpital Foch
Suresnes, 92150
Alexandra BIZOT, Dr, 01 46 25 45 02, a.bizot@hopital-foch.com
- Recruiting
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
Antoine Italiano, MD PhD, +33 (0)1 42 11 42 11, antoine.italiano@gustaveroussy.fr
Clementine Mahaut, PhD, +33 (0)1 42 11 23 34, clementine.mahaut@gustaveroussy.fr
About this study
The objective of STING study is to perform high throughput molecular analysis (next generation sequencing +/- immunological profiling) to estimate the proportion of patients with cancer presenting at least one targetable genomic alteration.
Read the detailed description
STING is a biology driven, multicenter study designed to identify actionable molecular alterations in cancer patients and to explore mechanisms of sensitivity and resistance to anti-cancer treatment
- In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling
- Patients included in the STING study and for whom a targetable genomic alteration had been identified might be subsequently included in a clinical trial running at Gustave Roussy or another participating center.
- Conditions
- Solid Tumor, Unspecified, Adult
- Being tested
- Biopsy
- Keywords
- immunological profiling, targetable oncogenic aberration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Blood and tumor samples for Genetic Profiling research
| Study group | Role | What they receive |
|---|---|---|
| solid tumor or hematological malignancy | Experimental | Not described Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients presenting at least one targetable genomic alteration
Number of patients presenting at least one targetable genomic alteration
Measured: 2 months after the last enrollment
Proportion of patients presenting at least one targetable genomic alteration
Proportion of patients presenting at least one targetable genomic alteration
Measured: 2 months after the last enrollment
Secondary outcomes (4)
Rate of molecular profiling information including utilization of information for standard regimens or clinical trials of molecularly targeted therapies
For a patient with molecular results available utilization of molecular profiling information is defined as Inclusion in a clinical trial assessing a drug matched to the molecular alteration And/or Treatment with an approved drug matched with the molecular alteration
Measured: 2 months after the last enrollment
Objective response rate
Measured: 24 months post treatment after the last enrollment
Progression-free survival
Measured: 24 months post treatment after the last enrollment
Overall survival
Measured: 24 months post treatment after the last enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start10 May 2021
- Primary completion10 May 2033 (estimated)
- Study completion10 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, Unspecified, AdultStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proportion of patients presenting at least one genomic alteration will be estimated in the eligible NGS population and reported using frequency and proportion. The 95% two-sided confidence limits (95%CI) will be provided for the estimated proportion (binomial law). In addition, counts, proportions and 95%CI will be reported for each individual genomic alteration. Survival data will be analysed by standard time-to-event survival techniques.
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Italiano, MD PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932525
- Sponsor's protocol ID
- 2020-A03547-32
- Other IDs
- 2020/3196
- Acronym
- STING
- Status last verified
- Feb 2026
- First submitted
- 1 Jun 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dawi L, Belkouchi Y, Lawrance L, Gautier O, Ammari S, Vasseur D, Wirth F, Hadchiti J, Morer S, David C, Bidault F, Balleyguier C, Kind M, Bayle A, Belcaid L, Aldea M, Nicotra C, Geraud A, Sakkal M, Blanc-Durand F, Moog S, Mosele MF, Tagliamento M, Bernard-Tessier A, Verret B, Smolenschi C, Auger N, Gazzah A, Micol JB, Caron O, Hollebecque A, Loriot Y, Besse B, Lacroix L, Rouleau E, Ponce S, Andre F, Soria JC, Barlesi F, Muller S, Cournede PH, Talbot H, Italiano A, Lassau N. Liquid Biopsy versus CT: Comparison of Tumor Burden Quantification in 1065 Patients with Metastases. Radiology. 2024 Nov;313(2):e232674. doi: 10.1148/radiol.232674.
PubMed 39589242Rodriguez J, Baldini C, Bayle A, Pages A, Danlos FX, Vasseur D, Rouleau E, Lacroix L, Alonso de Castro B, Goldschmidt V, Seknazi L, Hollebecque A, Michot JM, Champiat S, Marabelle A, Ouali K, Marzac C, Ponce S, Micol JB, Chaput N, Massard C, Italiano A. Impact of Clonal Hematopoiesis-Associated Mutations in Phase I Patients Treated for Solid Tumors: An Analysis of the STING Trial. JCO Precis Oncol. 2024 May;8:e2300631. doi: 10.1200/PO.23.00631.
PubMed 38815178Helal C, Pobel C, Bayle A, Vasseur D, Nicotra C, Blanc-Durand F, Naoun N, Bernard-Tessier A, Patrikidou A, Colomba E, Flippot R, Fuerea A, Auger N, Ngo Camus M, Besse B, Lacroix L, Rouleau E, Ponce S, Italiano A, Loriot Y. Clinical utility of plasma ctDNA sequencing in metastatic urothelial cancer. Eur J Cancer. 2023 Dec;195:113368. doi: 10.1016/j.ejca.2023.113368. Epub 2023 Oct 6.
PubMed 37897866Aldea M, Tagliamento M, Bayle A, Vasseur D, Verge V, Marinello A, Danlos FX, Blanc-Durand F, Bernard E, Cerbone L, Mosele MF, Renneville A, Hadoux J, Loriot Y, Sakkal M, Vozy A, Sarkozy C, Smolenschi C, Nicotra C, Martin-Romano P, Boccon-Gibod C, Habza W, Lazarovici J, Ponce S, Hollebecque A, Marzac C, Lacroix L, Barlesi F, Andre F, Besse B, Rouleau E, Italiano A, Micol JB. Liquid Biopsies for Circulating Tumor DNA Detection May Reveal Occult Hematologic Malignancies in Patients With Solid Tumors. JCO Precis Oncol. 2023 Mar;7:e2200583. doi: 10.1200/PO.22.00583.
PubMed 36862966
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gustave Roussy Cancer Profiling
- ClinicalTrials.gov ID
- NCT04932525
- Acronym / sponsor ID
- STING / 2020-A03547-32
- Conditions
- Solid Tumor, Unspecified, Adult
- Keywords
- immunological profiling, targetable oncogenic aberration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 10 May 2033 (estimated)
- Study completion
- 10 May 2033 (estimated)
- First posted
- 21 Jun 2021 (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 objective of STING study is to perform high throughput molecular analysis (next generation sequencing +/- immunological profiling) to estimate the proportion of patients with cancer presenting at least one targetable genomic alteration.
Detailed description
STING is a biology driven, multicenter study designed to identify actionable molecular alterations in cancer patients and to explore mechanisms of sensitivity and resistance to anti-cancer treatment
- In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling
- Patients included in the STING study and for whom a targetable genomic alteration had been identified might be subsequently included in a clinical trial running at Gustave Roussy or another participating center.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proportion of patients presenting at least one genomic alteration will be estimated in the eligible NGS population and reported using frequency and proportion. The 95% two-sided confidence limits (95%CI) will be provided for the estimated proportion (binomial law). In addition, counts, proportions and 95%CI will be reported for each individual genomic alteration. Survival data will be analysed by standard time-to-event survival techniques.
| Arm | Type | Receives |
|---|---|---|
| solid tumor or hematological malignancy | Experimental | Procedure: Biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Histology: solid malignant tumor or hematological malignancy.
- Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
- Voluntary signed and dated written informed consent prior to any study specific procedure.
Key exclusion criteria (4 listed)
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Pregnant or breast-feeding women
- Minors (Age < 18 years)
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 |
|---|---|---|
| BiopsyBlood and tumor samples for Genetic Profiling research | Procedure or surgery | solid tumor or hematological malignancy |
Primary outcome
Number of patients presenting at least one targetable genomic alteration
Time frame: 2 months after the last enrollment
Number of patients presenting at least one targetable genomic alteration
Proportion of patients presenting at least one targetable genomic alteration
Time frame: 2 months after the last enrollment
Proportion of patients presenting at least one targetable genomic alteration
4 secondary outcomes
Rate of molecular profiling information including utilization of information for standard regimens or clinical trials of molecularly targeted therapies
Time frame: 2 months after the last enrollment
Objective response rate
Time frame: 24 months post treatment after the last enrollment
Progression-free survival
Time frame: 24 months post treatment after the last enrollment
Overall survival
Time frame: 24 months post treatment after the last enrollment
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 6 Feb 2026.
- Derived from this study: PubMed 39589242Dawi L, Belkouchi Y, Lawrance L, Gautier O, Ammari S, Vasseur D, Wirth F, Hadchiti J, Morer S, David C, Bidault F, Balleyguier C, Kind M, Bayle A, Belcaid L, Aldea M, Nicotra C, Geraud A, Sakkal M, Blanc-Durand F, Moog S, Mosele MF, Tagliamento M, Bernard-Tessier A, Verret B, Smolenschi C, Auger N, Gazzah A, Micol JB, Caron O, Hollebecque A, Loriot Y, Besse B, Lacroix L, Rouleau E, Ponce S, Andre F, Soria JC, Barlesi F, Muller S, Cournede PH, Talbot H, Italiano A, Lassau N. Liquid Biopsy versus CT: Comparison of Tumor Burden Quantification in 1065 Patients with Metastases. Radiology. 2024 Nov;313(2):e232674. doi: 10.1148/radiol.232674.
- Derived from this study: PubMed 38815178Rodriguez J, Baldini C, Bayle A, Pages A, Danlos FX, Vasseur D, Rouleau E, Lacroix L, Alonso de Castro B, Goldschmidt V, Seknazi L, Hollebecque A, Michot JM, Champiat S, Marabelle A, Ouali K, Marzac C, Ponce S, Micol JB, Chaput N, Massard C, Italiano A. Impact of Clonal Hematopoiesis-Associated Mutations in Phase I Patients Treated for Solid Tumors: An Analysis of the STING Trial. JCO Precis Oncol. 2024 May;8:e2300631. doi: 10.1200/PO.23.00631.
- Derived from this study: PubMed 37897866Helal C, Pobel C, Bayle A, Vasseur D, Nicotra C, Blanc-Durand F, Naoun N, Bernard-Tessier A, Patrikidou A, Colomba E, Flippot R, Fuerea A, Auger N, Ngo Camus M, Besse B, Lacroix L, Rouleau E, Ponce S, Italiano A, Loriot Y. Clinical utility of plasma ctDNA sequencing in metastatic urothelial cancer. Eur J Cancer. 2023 Dec;195:113368. doi: 10.1016/j.ejca.2023.113368. Epub 2023 Oct 6.
- Derived from this study: PubMed 36862966Aldea M, Tagliamento M, Bayle A, Vasseur D, Verge V, Marinello A, Danlos FX, Blanc-Durand F, Bernard E, Cerbone L, Mosele MF, Renneville A, Hadoux J, Loriot Y, Sakkal M, Vozy A, Sarkozy C, Smolenschi C, Nicotra C, Martin-Romano P, Boccon-Gibod C, Habza W, Lazarovici J, Ponce S, Hollebecque A, Marzac C, Lacroix L, Barlesi F, Andre F, Besse B, Rouleau E, Italiano A, Micol JB. Liquid Biopsies for Circulating Tumor DNA Detection May Reveal Occult Hematologic Malignancies in Patients With Solid Tumors. JCO Precis Oncol. 2023 Mar;7:e2200583. doi: 10.1200/PO.22.00583.
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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.
Antoine Italiano, MD PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Solid Tumor, Unspecified, Adult, run by Gustave Roussy, Cancer Campus, Grand Paris at 4 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 4 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: looking for participants now, as of the sponsor's last update on 6 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 4 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 Antoine Italiano, MD PhD (+33 (0)1 42 11 42 11 ext. 34 71, antoine.italiano@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients presenting at least one targetable genomic alteration (time frame: 2 months after the last enrollment). The study lists 2 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 NCT04932525, which also lists 4 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 6 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.