Colorectal CancerEXOSCOL01NCT04394572
Identification of New Diagnostic Protein Markers for Colorectal Cancer
An observational study of Colorectal Cancer, run by CHU de Reims at 1 site in France.
Trial summary
The search for biochemical markers in patient's blood for non-invasive colorectal cancer diagnostic has not yielded satisfactory results to date. The search for blood in the stool by enzymatic techniques has certainly allowed the diminution of colorectal cancer mortality but its low sensitivity is still a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Blood sample
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2021to 7 Oct 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with and without colorectal cancer
Who may be able to join
- Immunoassay for stool positive blood test or family screening
- Patients seen in consultation for a colonoscopy
- Patient who gave their consent for the study (signed consent form)
- Patient affiliated to a health insurance plan
Who cannot join
- History of other cancers (except for cervical cancer or basal cell carcinoma treated for curative purposes)
- Patient under chemotherapy
- Patients with a known familial mutation (APC, MSI, MYH)
- Patients protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of New Diagnostic Protein Markers for Colorectal Cancer in Circulating Tumor Exosomes
The search for biochemical markers in patient's blood for non-invasive colorectal cancer diagnostic has not yielded satisfactory results to date. The search for blood in the stool by enzymatic techniques has certainly allowed the diminution of colorectal cancer mortality but its low sensitivity is still a disadvantage. The new immunological tests for search blood test in the stool are more sensitive and more specific but still insufficient. The originality of this project is based on the use of new technology developed in fundamental research based on the detection of circulating exosomes from tumor cells in the patient's serum. The detection of protein markers transported by tumor exosomes is original and innovative approach because it's still not considered in the literature. The use of innovative and non-invasive health technologies for the patient is an important factor in the care of patients in their health care journey. The non-invasive nature of the project could reduce the reticence of patients to participate in cancer screening.
The results expected from the study can have a direct impact on the management of patients suspected of having colon cancer and thus make it possible to optimize the earliness of their diagnosis.
Read the detailed description
In terms of frequency, colorectal cancer is the third most common cancer diagnosed in men and the second in women. Screening for colon and rectal cancer is based on the search for blood in the stool. The detection of occult bleeding is an indication for colonoscopy to find the origin of this bleeding. In this context, the search for biochemical markers in the blood of patients for diagnostic purposes has not yielded satisfactory results to date. Cancer cells, including colorectal cancer cells, release extracellular vesicles that contain proteins, mRNAs, DNA that can be transferred to neighboring cells but that also circulate through the blood stream and can modulate tumor progression and metastatic spread. These extracellular vesicles are of two types: exosomes (40 to 100 nm in diameter) formed by budding of endosome membranes and microvesicles (100 to 1000 nm in diameter) resulting from the budding of plasma membrane. Exosomes carry transmembrane proteins on their surface, called tetraspanins (CD9, CD63, CD81) but they also contain proteases involved in the degradation of the extracellular matrix, integrins involved in the tropism of metastases, and matrix macromolecules involved in the control of tumor invasion. The working hypothesis is that some of these exosomal proteins may be good diagnostic and / or prognostic markers for colorectal cancer. This project will aim to isolate exosomes from patient blood and to quantify previously cited proteins according to the accreditation criteria of clinical laboratory biology analyzes. For this purpose, exosomes will be isolated from sera of patients and their number, size and protein composition will be characterized. This project is an innovative and non-invasive prospective approach in the screening of protein markers for colorectal cancer diagnostic and / or prognostic.
- Conditions
- Colorectal Cancer
- Being tested
- Blood sample
- Keywords
- exosome ; colon cancer; integrin; matrix metalloproteinases
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
All patients included in the study will have blood sample
| Study group | Role | What they receive |
|---|---|---|
| colorectal cancer | Patients with and without colorectal cancer Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on macromolecules
Sensitivity and specificity of macromolecules
Measured: Day 1
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on integrins
Sensitivity and specificity of integrins
Measured: Day 1
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on metallo proteases
Sensitivity and specificity of metallo proteases
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start7 Jan 2021
- Primary completion29 Jul 2021
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394572
- Sponsor's protocol ID
- PO19143*
- Acronym
- EXOSCOL01
- Status last verified
- Oct 2022
- First submitted
- 31 Jan 2020
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Diagnostic Protein Markers for Colorectal Cancer in Circulating Tumor Exosomes
- ClinicalTrials.gov ID
- NCT04394572
- Acronym / sponsor ID
- EXOSCOL01 / PO19143*
- Conditions
- Colorectal Cancer
- Keywords
- exosome ; colon cancer; integrin; matrix metalloproteinases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 19 May 2020 (actual)
- 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.
The search for biochemical markers in patient's blood for non-invasive colorectal cancer diagnostic has not yielded satisfactory results to date. The search for blood in the stool by enzymatic techniques has certainly allowed the diminution of colorectal cancer mortality but its low sensitivity is still a disadvantage. The new immunological tests for search blood test in the stool are more sensitive and more specific but still insufficient. The originality of this project is based on the use of new technology developed in fundamental research based on the detection of circulating exosomes from tumor cells in the patient's serum. The detection of protein markers transported by tumor exosomes is original and innovative approach because it's still not considered in the literature. The use of innovative and non-invasive health technologies for the patient is an important factor in the care of patients in their health care journey. The non-invasive nature of the project could reduce the reticence of patients to participate in cancer screening.
The results expected from the study can have a direct impact on the management of patients suspected of having colon cancer and thus make it possible to optimize the earliness of their diagnosis.
Detailed description
In terms of frequency, colorectal cancer is the third most common cancer diagnosed in men and the second in women. Screening for colon and rectal cancer is based on the search for blood in the stool. The detection of occult bleeding is an indication for colonoscopy to find the origin of this bleeding. In this context, the search for biochemical markers in the blood of patients for diagnostic purposes has not yielded satisfactory results to date. Cancer cells, including colorectal cancer cells, release extracellular vesicles that contain proteins, mRNAs, DNA that can be transferred to neighboring cells but that also circulate through the blood stream and can modulate tumor progression and metastatic spread. These extracellular vesicles are of two types: exosomes (40 to 100 nm in diameter) formed by budding of endosome membranes and microvesicles (100 to 1000 nm in diameter) resulting from the budding of plasma membrane. Exosomes carry transmembrane proteins on their surface, called tetraspanins (CD9, CD63, CD81) but they also contain proteases involved in the degradation of the extracellular matrix, integrins involved in the tropism of metastases, and matrix macromolecules involved in the control of tumor invasion. The working hypothesis is that some of these exosomal proteins may be good diagnostic and / or prognostic markers for colorectal cancer. This project will aim to isolate exosomes from patient blood and to quantify previously cited proteins according to the accreditation criteria of clinical laboratory biology analyzes. For this purpose, exosomes will be isolated from sera of patients and their number, size and protein composition will be characterized. This project is an innovative and non-invasive prospective approach in the screening of protein markers for colorectal cancer diagnostic and / or prognostic.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer | – | Biological: Blood samplePatients with and without colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without colorectal cancer
Key inclusion criteria (4 listed)
- Immunoassay for stool positive blood test or family screening
- Patients seen in consultation for a colonoscopy
- Patient who gave their consent for the study (signed consent form)
- Patient affiliated to a health insurance plan
Key exclusion criteria (4 listed)
- History of other cancers (except for cervical cancer or basal cell carcinoma treated for curative purposes)
- Patient under chemotherapy
- Patients with a known familial mutation (APC, MSI, MYH)
- Patients protected by law
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 sampleAll patients included in the study will have blood sample | Biological | colorectal cancer |
Primary outcome
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on macromolecules
Time frame: Day 1
Sensitivity and specificity of macromolecules
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on integrins
Time frame: Day 1
Sensitivity and specificity of integrins
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on metallo proteases
Time frame: Day 1
Sensitivity and specificity of metallo proteases
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 10 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by CHU de Reims 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 4 inclusion and 4 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 10 Oct 2022. 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?
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on macromolecules (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2022.