Solid Tumor, Unspecified, Adult
Conditions
Keywords
immunological profiling, targetable oncogenic aberration
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.
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.
Interventions
PROCEDUREBiopsy
Blood and tumor samples for Genetic Profiling research
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients presenting at least one targetable genomic alteration | 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 | 2 months after the last enrollment | Proportion of patients presenting at least one targetable genomic alteration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | — |
Countries
France
Contacts
CONTACTAntoine Italiano, MD PhD
CONTACTClementine MAHAUT
PRINCIPAL_INVESTIGATORAntoine Italiano, MD PhD
Gustave Roussy, Cancer Campus, Grand Paris
Outcome results
None listed