CancerEXODIAGNCT02662621
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
A study testing blood samples and Urine samples in people with Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- blood samples and Urine samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2015to 8 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Affiliation to a social security system,
- Signed Informed consent.
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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).
- Conditions
- Cancer
- Being tested
- blood samples, Urine samples
- Keywords
- personalized care, early diagnosis, ovarian cancer, breast cancer, lung cancer, Early Detection, Cancer [E01.390.500]
- Medical subject headings
- Neoplasms, Disease, Ovarian Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
Urine samplesOther
| Study group | Role | What they receive |
|---|---|---|
| ill patient | Other | Patient with a cancer disease Receives: Other: blood samples; Other: Urine samples |
| Healthy volunter | Other | Subject without any cancer pathology Receives: Other: blood samples; Other: Urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of HSP70 exosomes in the blood and urine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start15 Dec 2015
- Primary completion15 Dec 2015
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U866 Faculté de Médecine et Pharmacie
- Responsible party
- Sponsor
- Investigators
- Nicolas ISAMBERT, MD, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662621
- Sponsor's protocol ID
- 2014-A01638-39
- Acronym
- EXODIAG
- Status last verified
- Jun 2025
- First submitted
- 20 Jan 2016
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chanteloup G, Cordonnier M, Isambert N, Bertaut A, Marcion G, Garrido C, Gobbo J. Membrane-bound exosomal HSP70 as a biomarker for detection and monitoring of malignant solid tumours: a pilot study. Pilot Feasibility Stud. 2020 Mar 3;6:35. doi: 10.1186/s40814-020-00577-2. eCollection 2020.
PubMed 32161659
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02662621
- Acronym / sponsor ID
- EXODIAG / 2014-A01638-39
- Conditions
- Cancer
- Keywords
- personalized care, early diagnosis, ovarian cancer, breast cancer, lung cancer, Early Detection, Cancer [E01.390.500]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Collaborators
- INSERM U866 Faculté de Médecine et Pharmacie
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ill patient | Other | Other: blood samples, Other: Urine samplesPatient with a cancer disease |
| Healthy volunter | Other | Other: blood samples, Other: Urine samplesSubject without any cancer pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples | Other | Healthy volunter, ill patient |
| Urine samples | Other | Healthy volunter, ill patient |
Primary outcome
concentration of HSP70 exosomes in the blood and urine
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 32161659Chanteloup G, Cordonnier M, Isambert N, Bertaut A, Marcion G, Garrido C, Gobbo J. Membrane-bound exosomal HSP70 as a biomarker for detection and monitoring of malignant solid tumours: a pilot study. Pilot Feasibility Stud. 2020 Mar 3;6:35. doi: 10.1186/s40814-020-00577-2. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas ISAMBERT, MD principal investigator
Centre Georges François Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples and Urine samples in people with Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of HSP70 exosomes in the blood and urine (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.