Clinical trial NCT04932525: Gustave Roussy Cancer Profiling
Official title: Gustave Roussy Cancer Profiling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Unspecified, Adult
Keywords: immunological profiling
targetable oncogenic aberration
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients presenting at least one targetable genomic alteration
timeFrame: 2 months after the last enrollment
measure: Proportion of patients presenting at least one targetable genomic alteration
timeFrame: 2 months after the last enrollment
Secondary outcomes:
measure: Rate of molecular profiling information including utilization of information for standard regimens or clinical trials of molecularly targeted therapies
timeFrame: 2 months after the last enrollment
measure: Objective response rate
timeFrame: 24 months post treatment after the last enrollment
measure: Progression-free survival
timeFrame: 24 months post treatment after the last enrollment
measure: Overall survival
timeFrame: 24 months post treatment after the last enrollment
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
state: Val De Marne
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Antoine Italiano, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: