Colorectal CancerMICADONCT04707365
Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort
A study testing Tumor samples in people with Colorectal Cancer and Pancreas Tumor, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Pancreas Tumor, Biliary Tract Tumor
- What is being tested?
- Tumor samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Mar 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Colorectal or pancreatic adenocarcinoma or biliary tract adenocarcinoma
- Cytologically or histologically proven adenocarcinoma, regardless of stage and treatment
- Age ≥ 18 years old
- Diagnosed from 2015 onwards
- Signed Consent
- Affiliation to a social security scheme (including CMU (Universal health coverage))
Who cannot join
- Patient under guardianship, curatorship or safeguarding of justice
- Pregnant or breastfeeding woman
- Any medical, psychological or social situation that could prevent compliance with the protocol according to the investigator's assessment.
- Refusal to participate in the study
- Patient on AME (state medical assistance)
- Persons deprived of liberty by a judicial or administrative decision
- Persons under psychiatric care
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment
Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies.
Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored.
Read more
Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers.
Method: Retrospective and prospective monocentric cohort study
- Conditions
- Colorectal Cancer, Pancreas Tumor, Biliary Tract Tumor, Immune System and Related Disorders
- Being tested
- Tumor samples
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor samplesBiological
for each patient: liver sampling, blood samples ( serum, plasma, PBMC, whole blood), per-endoscopic bile sampling, stool samples, and materials derived from fresh tumors
| Study group | Role | What they receive |
|---|---|---|
| digestive cancers | Experimental | Colorectal and pancreatobiliary cancers Receives: Biological: Tumor samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Overall survival (OS): vital status (alive/deceased)
Measured: observation from first cancer treatment date until date of death or 10 years follow up if patient alive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2035 (estimated)
- Study completionMar 2035 (estimated)
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 Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective and prospective monocentric cohort study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pr Tournigand, Study director, AP-HP Henri Mondor Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707365
- Sponsor's protocol ID
- APHP190090
- Other IDs
- IDRCB :2019-A00071-56
- Acronym
- MICADO
- Status last verified
- Dec 2020
- First submitted
- 12 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: AP-HP is the owner of the data and no use or transmission to a third party may be made without its prior consent.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment
- ClinicalTrials.gov ID
- NCT04707365
- Acronym / sponsor ID
- MICADO / APHP190090
- Conditions
- Colorectal Cancer, Pancreas Tumor, Biliary Tract Tumor, Immune System and Related Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2035 (estimated)
- Study completion
- Mar 2035 (estimated)
- First posted
- 13 Jan 2021 (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.
Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies.
Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored.
Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers.
Method: Retrospective and prospective monocentric cohort study
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective and prospective monocentric cohort study
| Arm | Type | Receives |
|---|---|---|
| digestive cancers | Experimental | Biological: Tumor samplesColorectal and pancreatobiliary cancers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Colorectal or pancreatic adenocarcinoma or biliary tract adenocarcinoma
- Cytologically or histologically proven adenocarcinoma, regardless of stage and treatment
- Age ≥ 18 years old
- Diagnosed from 2015 onwards
- Signed Consent
Key exclusion criteria (7 listed)
- Patient under guardianship, curatorship or safeguarding of justice
- Pregnant or breastfeeding woman
- Any medical, psychological or social situation that could prevent compliance with the protocol according to the investigator's assessment.
- Refusal to participate in the study
- Patient on AME (state medical assistance)
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 |
|---|---|---|
| Tumor samplesfor each patient: liver sampling, blood samples ( serum, plasma, PBMC, whole blood), per-endoscopic bile sampling, stool samples, and materials derived from fresh tumors | Biological | digestive cancers |
Primary outcome
overall survival
Time frame: observation from first cancer treatment date until date of death or 10 years follow up if patient alive
Overall survival (OS): vital status (alive/deceased)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No. AP-HP is the owner of the data and no use or transmission to a third party may be made without its prior consent.
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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.
Pr Tournigand study director
AP-HP Henri Mondor Créteil
Questions about this trial
What is this clinical trial studying?
A study testing Tumor samples in people with Colorectal Cancer and Pancreas Tumor, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Tournigand, MD-PHD (0149812567 ext. 0033, christophe.tournigand@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: observation from first cancer treatment date until date of death or 10 years follow up if patient alive). 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 13 Jan 2021.