Gustave Roussy Cancer Profiling

Gustave Roussy, Cancer Campus, Grand Paris20,000 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

20,000

Conditions

Solid Tumor, Unspecified, Adult

Interventions

BiopsyPROCEDURE

Blood and tumor samples for Genetic Profiling research

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (4)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, France

RECRUITING

Hôpital Marie-Lannelongue

Le Plessis-Robinson, France

RECRUITING

Hôpital Saint-Joseph

Paris, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Number 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

Time frame: 2 months after the last enrollment

Secondary Outcomes

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

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

Central 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

Data from ClinicalTrials.gov

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