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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)

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ClinicalTrials.gov Identifier: NCT02662621
Recruitment Status : Completed
First Posted : January 25, 2016
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Cancer Other: blood samples Other: Urine samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study With the Aim to Quantify a Stress Protein in the Blood and in the Urine for Early Diagnosis of Malgnant Solid Tumors
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : December 15, 2015
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. concentration of HSP70 exosomes in the blood and urine [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662621


Locations
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France
CGFL
Dijon, France, 21079
Sponsors and Collaborators
Centre Georges Francois Leclerc
Investigators
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Principal Investigator: Nicolas ISAMBERT, MD Centre Georges François Leclerc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT02662621    
Other Study ID Numbers: 2014-A01638-39
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: November 2019
Keywords provided by Centre Georges Francois Leclerc:
personalized care
early diagnosis
ovarian cancer
breast cancer
lung cancer
Early Detection
Cancer [E01.390.500]