Colorectal CarcinomaMICROCOLNCT03969784
Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
A study testing blood draw, tumoral biopsy tissus in people with Colorectal Carcinoma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Peritoneal carcinomatosis (PC), a tumoral tumor of the peritoneum, is a frequent metastatic localization of colorectal cancer (CRC, 13%). Long regarded as a palliative situation, its management has progressed significantly with a curative treatment based on a complete cytoreduction surgery coupled with intraperitoneal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- blood draw, tumoral biopsy tissus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 3 Mar 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient presenting a peritoneal carcinomatosis from colorectal cancer origin
Who cannot join
- patient presenting a peritoneal carcinomatosis from other pathologies than colorectal cancer origin
Trial locations and contacts
1 site in 1 country.
About this study
Peritoneal carcinomatosis (PC), a tumoral tumor of the peritoneum, is a frequent metastatic localization of colorectal cancer (CRC, 13%). Long regarded as a palliative situation, its management has progressed significantly with a curative treatment based on a complete cytoreduction surgery coupled with intraperitoneal hyperthermic chemotherapy. However current screening tools, tumor markers (ACE, CA19-9, CA125) and abdominopelvic CT scan are insufficient, to diagnose CP early. A non-invasive biomarker, more sensitive and more specific than currently available tumor markers, would be a major advance in oncology. Microparticles (MPs), vesicles from extracellular membrane budding in response to cell activation or apoptosis of different cell types, have been described as implicated in tumor progression, procoagulant activity associated with cancer, and initiation of metastatic niches. A specific microparticulate (microparticulosome) signature has been reported in patients with CRC, particularly in the presence of a thromboembolic event. However, there is currently no data on PMs and their involvement in CP. In addition, CP and surgery coupled with hyperthermic intraperitoneal chemotherapy are major risk factors for thromboembolic complications. The characterization of prothrombotic PMs is therefore essential to predict such event.
The main objective of this project is to characterize the microparticulate signature of CP of colorectal origin and to compare it with that of CP without CP. The secondary objectives are to compare the microparticulate signature obtained on peripheral venous samples and intraoperative tumor samples, evaluate the evolution of the microparticulate signature between the beginning and the end of the intervention, then correlate the peripheral signature to the oncological follow-up of the patients with CP and the occurrence of a thromboembolic event.
- Conditions
- Colorectal Carcinoma
- Being tested
- blood draw, tumoral biopsy tissus
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood draw, tumoral biopsy tissusOther
Patient will have specific blood draw and part of their tumoral tissu biopsied
| Study group | Role | What they receive |
|---|---|---|
| colorectal cancer patient with peritoneal carcinosis | Experimental | Not described Receives: Other: blood draw, tumoral biopsy tissus |
| colorectal cancer patient without metastasis | Active comparator | Not described Receives: Other: blood draw, tumoral biopsy tissus |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of microparticule
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 Sep 2019
- Primary completion28 Mar 2024
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Garrido, Study director, Assitance Publique Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969784
- Sponsor's protocol ID
- 2019-A00688-49
- Other IDs
- 2019-08
- Acronym
- MICROCOL
- Status last verified
- Nov 2025
- First submitted
- 28 May 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
- ClinicalTrials.gov ID
- NCT03969784
- Acronym / sponsor ID
- MICROCOL / 2019-A00688-49
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 31 May 2019 (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.
Peritoneal carcinomatosis (PC), a tumoral tumor of the peritoneum, is a frequent metastatic localization of colorectal cancer (CRC, 13%). Long regarded as a palliative situation, its management has progressed significantly with a curative treatment based on a complete cytoreduction surgery coupled with intraperitoneal hyperthermic chemotherapy. However current screening tools, tumor markers (ACE, CA19-9, CA125) and abdominopelvic CT scan are insufficient, to diagnose CP early. A non-invasive biomarker, more sensitive and more specific than currently available tumor markers, would be a major advance in oncology. Microparticles (MPs), vesicles from extracellular membrane budding in response to cell activation or apoptosis of different cell types, have been described as implicated in tumor progression, procoagulant activity associated with cancer, and initiation of metastatic niches. A specific microparticulate (microparticulosome) signature has been reported in patients with CRC, particularly in the presence of a thromboembolic event. However, there is currently no data on PMs and their involvement in CP. In addition, CP and surgery coupled with hyperthermic intraperitoneal chemotherapy are major risk factors for thromboembolic complications. The characterization of prothrombotic PMs is therefore essential to predict such event.
The main objective of this project is to characterize the microparticulate signature of CP of colorectal origin and to compare it with that of CP without CP. The secondary objectives are to compare the microparticulate signature obtained on peripheral venous samples and intraoperative tumor samples, evaluate the evolution of the microparticulate signature between the beginning and the end of the intervention, then correlate the peripheral signature to the oncological follow-up of the patients with CP and the occurrence of a thromboembolic event.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer patient with peritoneal carcinosis | Experimental | Other: blood draw, tumoral biopsy tissus |
| colorectal cancer patient without metastasis | Active comparator | Other: blood draw, tumoral biopsy tissus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient presenting a peritoneal carcinomatosis from colorectal cancer origin
Key exclusion criteria (1 listed)
- patient presenting a peritoneal carcinomatosis from other pathologies than colorectal cancer origin
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 draw, tumoral biopsy tissusPatient will have specific blood draw and part of their tumoral tissu biopsied | Other | colorectal cancer patient with peritoneal carcinosis, colorectal cancer patient without metastasis |
Primary outcome
percentage of microparticule
Time frame: 3 years
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 20 Nov 2025.
- 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.
Emilie Garrido study director
Assitance Publique Hopitaux de Marseille
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 draw, tumoral biopsy tissus in people with Colorectal Carcinoma, run by Assistance Publique Hopitaux De Marseille 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 1 inclusion and 1 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 20 Nov 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?
percentage of microparticule (time frame: 3 years). 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 20 Nov 2025.