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 (EXODIAG)

March 27, 2020 updated by: Centre Georges Francois Leclerc

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CGFL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria for patients

  • 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.

Exclusion Criteria for patients:

  • 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).

Inclusion criteria for healthy volonter

  • 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 for healthy volonter

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ill patient
Patient with a cancer disease
Other: blood samples
Other: Urine samples
Other: Healthy volunter
Subject without any cancer pathology
Other: blood samples
Other: Urine samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
concentration of HSP70 exosomes in the blood and urine
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2015

Primary Completion (Actual)

December 15, 2015

Study Completion (Actual)

April 8, 2019

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01638-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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