Pilot Study With the Aim to Quantify a Stress Protein in the Blood and in the Urine for the Monitoring and Early Diagnosis of Malignant Solid Tumors

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: blood samples; Other: Urine samples

• Registration Number: NCT02662621
• Lead Sponsor: Centre Georges Francois Leclerc

Brief Summary

Recent studies shows that extracellular vesicles (named "exosomes") released by cancer cells exhibit at their membrane the stress protein HSP70, contrary to exosomes released by normal cells. These exosomes ("HSP70-exosomes") have a very important role in intercellular communication and have specific biological functions that can promote tumor progression. They are found in the different biological fluids such as blood and urine.

We have developed a protocol able to isolate exosomes in blood and urine. We also demonstrated that only exosomes derived from cancer cell have HSP70 at their membrane. Those results strongly suggest that we can only identify exosomes with HSP70 at the membrane in patients with cancer.

Detection of HSP70-exosomes in the diagnosis of patients is a promising pathway of research. Because a cancer cell can releases a large amount of exosomes (several billion) and since its appearance, our approach will allow to earlier detect cancer with respect to the use of imaging and circulating tumor cells (CTCs), which remains a rare event (about one CTC of 1 billion cells).

The aim of this study is to demonstrate that HSP70-exosomes could be used for early diagnosis of patients with malignant solid tumor. In order to demonstrate this, the objective of the study is to study blood and urine samples from 60 subjects with a malignant tumor and 20 healthy subjects (witness).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-15
• Primary Completion: 2015-12-15
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-25
• Study Completion: 2019-04-08
• Status Verified: 2019-11
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ill patient	blood samples	Patient with a cancer disease
ill patient	Urine samples	Patient with a cancer disease
Healthy volunter	blood samples	Subject without any cancer pathology
Healthy volunter	Urine samples	Subject without any cancer pathology

Primary Outcome Measures

Name	Time	Method
concentration of HSP70 exosomes in the blood and urine	1 year

Trial Locations

Locations (1)

CGFL; 🇫🇷 Dijon, France