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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2019-04-08

Brief Summary

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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).

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ill patient

Patient with a cancer disease

Group Type OTHER

blood samples

Intervention Type OTHER

Urine samples

Intervention Type OTHER

Healthy volunter

Subject without any cancer pathology

Group Type OTHER

blood samples

Intervention Type OTHER

Urine samples

Intervention Type OTHER

Interventions

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blood samples

Intervention Type OTHER

Urine samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women newly diagnosed with either:
* Infiltrating non-metastatic breast cancer (positive or negative HER2 status or hormone therapy)
* Breast cancer with a first metastasis evolution (positive or negative HER2 status or hormone therapy).
* Ovarian cancer stage III and IV,
* Men and women who are newly diagnosed non-small cell lung cancer metastatic,
* Age ≥18 years
* Affiliation to a social security system,
* Signed Informed consent.

* Men or women aged 50-70 years (mean age of onset of various cancers in the study)
* Affiliation to a social security system,
* Signed Informed consent.

Exclusion Criteria

* Patient with another synchronous tumor,
* Men with breast cancer,
* Positive HIV and / or HBV and / or HCV serology
* Patients unable to undergo a medical monitoring for geographical, social or psychological condition,
* Pregnant or nursing women,
* People enjoying a major protection system (including trusteeship and guardianship).

* history of cancer,
* Positive HIV and / or HBV and / or HCV serology
* Pregnant or nursing women,
* People enjoying a major protection system (including trusteeship and guardianship).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes