Colon AdenocarcinomaIMCONCT03015038
Study of the Immune Response in Colon Adenocarcinoma
An observational study of Colon Adenocarcinoma, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Duration of each part of the study per patient: Screening: From 1 to 4 weeks Sampling period (blood and tissue): 1 day Follow-up by patient: 60 months Total study duration by patient: 84 months Total inclusion duration: 24 months Total Follow-up duration: 60 months Total study duration: 84 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Adenocarcinoma
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2017to 5 Feb 2024
- 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: Patient with colon adenocarcinoma treated by surgery
Who may be able to join
- Patients aged 18 or more.
- Affiliation to a social security scheme
- Diagnosis of a colon adenocarcinoma.
- Patient have signed and dated consent of the study before undertaking procedures related to the study.
Who cannot join
- Patients under guardianship / curatorship
- Following Situations
- Persons unable to understand, read and / or sign an informed consent
- Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
- Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
- No affiliation to a social security scheme, a universal medical coverage or any similar plan.
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- Pregnant or lactating women.
- Patients with HIV seropositivity.
- Rectal tumor location.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude de la réponse Immunitaire Dans l'adénocarcinome Colique
Duration of each part of the study per patient:
- Screening: From 1 to 4 weeks
- Sampling period (blood and tissue): 1 day
- Follow-up by patient: 60 months
- Total study duration by patient: 84 months
- Total inclusion duration: 24 months
- Total Follow-up duration: 60 months
- Total study duration: 84 months
- Conditions
- Colon Adenocarcinoma
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune cells trafficking
Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).
Measured: Day 0
Secondary outcomes (2)
Infiltration of leucocytes in tumor tissue
Histochemical method with a panel of Ab.
Measured: Day 0
Safety (Number of adverse events, ECOG status)
Measured: After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start5 Feb 2017
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Innate Pharma
- Responsible party
- Sponsor
- Investigators
- Matthieu Allez, MD, PhD, Principal investigator, Hopital Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015038
- Sponsor's protocol ID
- C16-21
- Other IDs
- 2016-A01102-49
- Acronym
- IMCO
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2016
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bonnereau J, Courau T, Asesio N, Salfati D, Bouhidel F, Corte H, Hamoudi S, Hammoudi N, Lavole J, Vivier-Chicoteau J, Chardiny V, Maggiori L, Blery M, Remark R, Bonnafous C, Cattan P, Toubert A, Bhat P, Allez M, Aparicio T, Le Bourhis L. Autologous T cell responses to primary human colorectal cancer spheroids are enhanced by ectonucleotidase inhibition. Gut. 2023 Apr;72(4):699-709. doi: 10.1136/gutjnl-2021-326553. Epub 2022 Jul 8.
PubMed 35803702Courau T, Bonnereau J, Chicoteau J, Bottois H, Remark R, Assante Miranda L, Toubert A, Blery M, Aparicio T, Allez M, Le Bourhis L. Cocultures of human colorectal tumor spheroids with immune cells reveal the therapeutic potential of MICA/B and NKG2A targeting for cancer treatment. J Immunother Cancer. 2019 Mar 14;7(1):74. doi: 10.1186/s40425-019-0553-9.
PubMed 30871626
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la réponse Immunitaire Dans l'adénocarcinome Colique
- ClinicalTrials.gov ID
- NCT03015038
- Acronym / sponsor ID
- IMCO / C16-21
- Conditions
- Colon Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Innate Pharma
- Study start
- 5 Feb 2017 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 9 Jan 2017 (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.
Duration of each part of the study per patient:
- Screening: From 1 to 4 weeks
- Sampling period (blood and tissue): 1 day
- Follow-up by patient: 60 months
- Total study duration by patient: 84 months
- Total inclusion duration: 24 months
- Total Follow-up duration: 60 months
- Total study duration: 84 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with colon adenocarcinoma treated by surgery
Key inclusion criteria (4 listed)
- Patients aged 18 or more.
- Affiliation to a social security scheme
- Diagnosis of a colon adenocarcinoma.
- Patient have signed and dated consent of the study before undertaking procedures related to the study.
Key exclusion criteria (9 listed)
- Patients under guardianship / curatorship
- Following Situations
- Pregnant or lactating women.
- Patients with HIV seropositivity.
- Rectal tumor location.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune cells trafficking
Time frame: Day 0
Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).
2 secondary outcomes
Infiltration of leucocytes in tumor tissue
Time frame: Day 0
Safety (Number of adverse events, ECOG status)
Time frame: After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60)
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 Dec 2025.
- Results publication: PubMed 35803702Bonnereau J, Courau T, Asesio N, Salfati D, Bouhidel F, Corte H, Hamoudi S, Hammoudi N, Lavole J, Vivier-Chicoteau J, Chardiny V, Maggiori L, Blery M, Remark R, Bonnafous C, Cattan P, Toubert A, Bhat P, Allez M, Aparicio T, Le Bourhis L. Autologous T cell responses to primary human colorectal cancer spheroids are enhanced by ectonucleotidase inhibition. Gut. 2023 Apr;72(4):699-709. doi: 10.1136/gutjnl-2021-326553. Epub 2022 Jul 8.
- Results publication: PubMed 30871626Courau T, Bonnereau J, Chicoteau J, Bottois H, Remark R, Assante Miranda L, Toubert A, Blery M, Aparicio T, Allez M, Le Bourhis L. Cocultures of human colorectal tumor spheroids with immune cells reveal the therapeutic potential of MICA/B and NKG2A targeting for cancer treatment. J Immunother Cancer. 2019 Mar 14;7(1):74. doi: 10.1186/s40425-019-0553-9.
- 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.
Matthieu Allez, MD, PhD principal investigator
Hopital Saint Louis
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 Colon Adenocarcinoma, run by Institut National de la Santé Et de la Recherche Médicale, France 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 9 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 Dec 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?
Immune cells trafficking (time frame: Day 0). 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 NCT03015038, which also lists 2 linked publications.
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 Dec 2025.