Gustave Roussy Cancer Profiling

Phase 1

Recruiting

• Conditions: Solid Tumor, Unspecified, Adult
• Interventions: Procedure: Biopsy

• Registration Number: NCT04932525
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Study Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2028-05-10
• Study Completion: 2028-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
solid tumor or hematological malignancy	Biopsy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Progression-free survival	24 months post treatment after the last enrollment
Overall survival	24 months post treatment after the last enrollment
Objective response rate	24 months post treatment after the last enrollment

Trial Locations

Locations (1)

Gustave Roussy Cancer Campus Grand Paris; 🇫🇷 Villejuif, Val De Marne, France