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NCT Number: NCT02662621

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

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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Key information

Conditions

Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Disease Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CGFL

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood Samples

Other

Urine samples

Other

Primary outcomes

  1. concentration of HSP70 exosomes in the blood and urine

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Collaborators

  • INSERM U866 Faculté de Médecine et Pharmacie

Registry information

Official study 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

Acronym: EXODIAG

Important dates

Study start
2015
Primary completion
2015
Study completion
2019
First posted
Jan 25, 2016
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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