CompletedNot Applicable

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

France71 participantsStarted 2015-12-15

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

concentration of HSP70 exosomes in the blood and urine

Timeframe: 1 year

Trial details

NCT IDNCT02662621

SponsorCentre Georges Francois Leclerc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12-15

View on ClinicalTrials.gov More Cancer trials