Gustave Roussy Cancer Profiling

Solid Tumor, Unspecified, Adult Clinical Trial

— STING  

Official title:

Gustave Roussy Cancer Profiling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932525
• Other study ID #: 2020-A03547-32
• Secondary ID: 2020/3196
• Status: Recruiting
• Phase: Phase 1
• Start date: May 10, 2021
• Est. completion date: May 10, 2028

Study information

• Verified date: May 2023
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Antoine Italiano, MD PhD
• Phone: +33 (0)1 42 11 42 11
• Email: antoine.italiano[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: May 10, 2028
• Est. primary completion date: May 10, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Solid Tumor, Unspecified, Adult

Intervention

Procedure:
• Biopsy
Blood and tumor samples for Genetic Profiling research

Locations

Country	Name	City	State
France	Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Objective response rate		24 months post treatment after the last enrollment
Secondary	Progression-free survival		24 months post treatment after the last enrollment
Secondary	Overall survival		24 months post treatment after the last enrollment