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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02662621

Acronym

EXODIAG

Enrollment

Registered

2016-01-25

Start date

2015-12-15

Completion date

2019-04-08

Last updated

2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

personalized care, early diagnosis, ovarian cancer, breast cancer, lung cancer, Early Detection, Cancer [E01.390.500]

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).

Interventions

OTHERblood samples

OTHERUrine samples

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
concentration of HSP70 exosomes in the blood and urine	1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026