Gustave Roussy Cancer Profiling

NCT ID: NCT04932525

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2033-05-10

Brief Summary

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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

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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

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Solid Tumor, Unspecified, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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solid tumor or hematological malignancy

Group Type EXPERIMENTAL

Biopsy

Intervention Type PROCEDURE

Blood and tumor samples for Genetic Profiling research

Interventions

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Biopsy

Blood and tumor samples for Genetic Profiling research

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Histology: solid malignant tumor or hematological malignancy.
3. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
4. Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria

1. 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
2. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
3. Pregnant or breast-feeding women
4. Minors (Age \< 18 years)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine Italiano, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, France

Site Status RECRUITING

Hôpital Marie-Lannelongue

Le Plessis-Robinson, , France

Site Status RECRUITING

Hôpital Saint-Joseph

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Foch

Suresnes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Antoine Italiano, MD PhD

Role: CONTACT

+33 (0)1 42 11 42 11 ext. 34 71

Clementine MAHAUT

Role: CONTACT

+33 (0)1 42 11 23 34

Facility Contacts

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Antoine Italiano, MD PhD

Role: primary

+33 (0)1 42 11 42 11

Clementine Mahaut, PhD

Role: backup

+33 (0)1 42 11 23 34

Olaf MERCIER, Pr

Role: primary

Charles NALTET, Dr

Role: primary

01 44 12 37 52

Alexandra BIZOT, Dr

Role: primary

01 46 25 45 02

References

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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.

Reference Type DERIVED
PMID: 38815178 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37897866 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36862966 (View on PubMed)

Other Identifiers

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2020/3196

Identifier Type: OTHER

Identifier Source: secondary_id

2020-A03547-32

Identifier Type: -

Identifier Source: org_study_id

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