Colonic CancerIMMUNOCOLNCT04185272
Butyrophilins Role in Colon Cancer
A study testing analysis of BTN and BTNL status in people with Colonic Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Cancer
- What is being tested?
- analysis of BTN and BTNL status
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to Jun 2028
- 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
- Patient is older than 18 years old,
- Signed participation consent,
- Non-metastatic colon cancer immediately resectable or metastatic and liver synchronous for which it was decided a combined colic and liver surgery (metastatic patient at the outset) in multidisciplinary consultation meeting.
- Performance Status (PS) 0 or 1
- affiliated to the social security or beneficiary
Who cannot join
- Rectal cancer, colon cancer recurrence
- Emergency of colon cancer Surgery
- History of inflammatory disease of the digestive tract (Crohn's disease or ulcerative colitis)
- Patient who received neoadjuvant therapy other than chemotherapy
- Patient treated with immune-suppressors or long-course corticosteroids <12 months
- Pregnant women or likely to be pregnant (without effective contraception) or breastfeeding,
- Person in urgent situation, person under legal protection measure, or unable to express his / her consent,
- Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli-Calmettes
Marseille, 13273
Jihane PAKRADOUNI, PharmD, PhD, 33491223778, drci.up@ipc.unicancer.fr
Laurie-Anne GOUTY, PhD, 0491223778, drci.up@ipc.unicancer.fr
About this study
Official title: Role of Butyrophilins in Colon Cancers Aggressiveness Evaluation
quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer
- Conditions
- Colonic Cancer
- Being tested
- analysis of BTN and BTNL status
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of BTN and BTNL statusBiological
analysis of BTN and BTNL expression in colon cancer and hepatic metastasis
| Study group | Role | What they receive |
|---|---|---|
| non-metastatic colon cancer | Experimental | Not described Receives: Biological: analysis of BTN and BTNL status |
| metastatic colon cancer | Experimental | Not described Receives: Biological: analysis of BTN and BTNL status |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry
healthy and cancerous colon ad metastasis (if applicable) will be analysed by
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start30 Jun 2020
- Primary completion30 Jun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- colon cancer patients and metastatic colon cancer patients will be included in this study. We expect that BTNL molecules expression is different depending of the aggressiveness of the illness
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185272
- Sponsor's protocol ID
- IMMUNOCOL-IPC 2019-018
- Acronym
- IMMUNOCOL
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2019
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Butyrophilins in Colon Cancers Aggressiveness Evaluation
- ClinicalTrials.gov ID
- NCT04185272
- Acronym / sponsor ID
- IMMUNOCOL / IMMUNOCOL-IPC 2019-018
- Conditions
- Colonic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Dec 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.
quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- colon cancer patients and metastatic colon cancer patients will be included in this study. We expect that BTNL molecules expression is different depending of the aggressiveness of the illness
| Arm | Type | Receives |
|---|---|---|
| non-metastatic colon cancer | Experimental | Biological: analysis of BTN and BTNL status |
| metastatic colon cancer | Experimental | Biological: analysis of BTN and BTNL status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is older than 18 years old,
- Signed participation consent,
- Non-metastatic colon cancer immediately resectable or metastatic and liver synchronous for which it was decided a combined colic and liver surgery (metastatic patient at the outset) in multidisciplinary consultation meeting.
- Performance Status (PS) 0 or 1
- affiliated to the social security or beneficiary
Key exclusion criteria (8 listed)
- Rectal cancer, colon cancer recurrence
- Emergency of colon cancer Surgery
- History of inflammatory disease of the digestive tract (Crohn's disease or ulcerative colitis)
- Patient who received neoadjuvant therapy other than chemotherapy
- Patient treated with immune-suppressors or long-course corticosteroids <12 months
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 |
|---|---|---|
| analysis of BTN and BTNL statusanalysis of BTN and BTNL expression in colon cancer and hepatic metastasis | Biological | metastatic colon cancer, non-metastatic colon cancer |
Primary outcome
evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry
Time frame: 8 years
healthy and cancerous colon ad metastasis (if applicable) will be analysed by
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 1 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing analysis of BTN and BTNL status in people with Colonic Cancer, run by Institut Paoli-Calmettes 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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?
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 Jihane PAKRADOUNI, PharmD,PhD (04 91 22 37 78, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry (time frame: 8 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 1 Oct 2026.