Gustave Roussy Cancer Profiling

NCT04932525 | Recruiting

• 2 other identifiers: 2020-A03547-322020/3196
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Solid Tumor, Unspecified, Adult

Keywords

immunological profiling; targetable oncogenic aberration

Outcome Measures

Primary Outcomes (2)

• Number of patients presenting at least one targetable genomic alteration

  Number of patients presenting at least one targetable genomic alteration

  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

  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

  2 months after the last enrollment

• Objective response rate

  24 months post treatment after the last enrollment

• Progression-free survival

  24 months post treatment after the last enrollment

• Overall survival

  24 months post treatment after the last enrollment

Study Arms (1)

solid tumor or hematological malignancy

EXPERIMENTAL

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Blood and tumor samples for Genetic Profiling research

solid tumor or hematological malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (4)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

RECRUITING

Hôpital Marie-Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

Hôpital Saint-Joseph

Paris, 75014, France

NOT YET RECRUITING

Hôpital Foch

Suresnes, 92150, France

NOT YET RECRUITING

Related Publications (3)

• Rodriguez 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.

  PMID: 38815178 DERIVED

• Helal 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.

  PMID: 37897866 DERIVED

• Aldea 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.

  PMID: 36862966 DERIVED

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Antoine Italiano, MD PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Italiano, MD PhD

CONTACT

+33 (0)1 42 11 42 11; antoine.italiano@gustaveroussy.fr

Clementine MAHAUT

CONTACT

+33 (0)1 42 11 23 34; clementine.mahaut@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 21, 2021
• Study Start: May 10, 2021
• Primary Completion (Estimated): May 10, 2033
• Study Completion (Estimated): May 10, 2033
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (4)