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

Cancer Clinical Trial

— EXODIAG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662621
• Other study ID #: 2014-A01638-39
• Status: Completed
• Phase: N/A
• Start date: December 15, 2015
• Est. completion date: April 8, 2019

Study information

• Verified date: November 2019
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 8, 2019
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• blood samples

• Urine samples

Locations

Country	Name	City	State
France	CGFL	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of HSP70 exosomes in the blood and urine		1 year