Gustave Roussy Cancer Profiling

Study Overview
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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.

Official Title
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Gustave Roussy Cancer Profiling

Conditions
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Solid Tumor, Unspecified, Adult

Intervention / Treatment
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* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: solid tumor or hematological malignancy<br> | Procedure: Biopsy<br>* Blood and tumor samples for Genetic Profiling research<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunological profiling, targetable oncogenic aberration