Gustave Roussy Cancer Profiling (STING)

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Unspecified, Adult
• Intervention / Treatment: Procedure: Biopsy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Antoine Italiano, MD PhD; Phone Number: 34 71 +33 (0)1 42 11 42 11; Email: antoine.italiano@gustaveroussy.fr
• Study Contact Backup: Name: Maxime Frelaut, MD; Phone Number: +33 (0)1 42 11 42 11; Email: maxime.frelaut@gustaveroussy.fr

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94805
      • Recruiting
      • Gustave Roussy Cancer Campus Grand Paris
      • Contact: Antoine Italiano, MD PhD; Phone Number: +33 (0)1 42 11 42 11; Email: antoine.italiano@gustaveroussy.fr
      • Contact: Maxime Frelaut, PhD; Phone Number: +33 (0)1 42 11 42 11; Email: maxime.frelaut@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: solid tumor or hematological malignancy	Procedure: Biopsy; Blood and tumor samples for Genetic Profiling research

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Principal Investigator: Antoine Italiano, MD PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Anticipated): May 10, 2028
• Study Completion (Anticipated): May 10, 2028

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: immunological profiling; targetable oncogenic aberration
• Other Study ID Numbers: 2020-A03547-32; 2020/3196 (Other Identifier: CSET number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No