Colon CancerI-COMETNCT06435689
Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers
An observational study of Colon Cancer and Peritoneal Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Colorectal cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Peritoneal Carcinoma
- What is being tested?
- Sampling
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jun 2024to 15 Jun 2039
- Phase
- Observational
- 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
Study population: Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers
Who may be able to join
- Male or female 18 years of age or older
- Diagnosis of colorectal adenocarcinoma
- Scheduled resection of tumor and/or metastasis(es)
Who cannot join
- Patient's opposition to research
- Patients under guardianship
- The following situations
- Persons unable to understand and/or read the information leaflet
- Patient with one of the following functions: Investigator or co-investigator, research assistant, pharmacist, study coordinator or, having any involvement in the study
- Non-cooperative or potentially non-compliant person for the study and its procedures with foreseeable difficulties in regular follow-up over 5 years.
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- Non-affiliation with a social security scheme, Couverture Médicale Universelle or any equivalent scheme.
- Pregnant or breast-feeding women.
- HIV-positive patients.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hôpital Saint Louis - gastoenterology
Paris
Thomas Aparicio, Pr, thomas.aparicio@aphp.fr
Hôpital Saint Louis - visceral, oncological and endocrine surgery
Paris
Diane Goéré, Pr, diane.goere@aphp.fr
About this study
Official title: Etude et Modulation de la réponse Immunitaire Dans Les Cancers COlorectaux Primaires et METastatiques
Colorectal cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). Recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. Understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. Recently, the consensus molecular classification of CRC confirmed the importance of the immune response in CRC by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. However, immunotherapies are effective for only a minority of patients with metastatic CRC. Indeed, anti Programmed cell Death 1 (anti-PD-1), -PD-L1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (MSI), which only represents 5% of metastatic CRCs.
Thus, the aim of this study is to better understand the role of the immune system on the development of CRC and its possible modulation to treat or prevent metastatic recurrences.
- Conditions
- Colon Cancer, Peritoneal Carcinoma
- Being tested
- Sampling
- Keywords
- Organoids, T-cells, Metastasis, Immunotherapies
- Medical subject headings
- Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingOther
Blood and surgical specimen sampling the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers | Not described Receives: Other: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of immunotherapies in a co-culture model
Characterize effective immunotherapies in colorectal cancers by demonstrating their effectiveness in a co-culture model between cancer cells and autologous T cells.
Measured: At 1 year
Secondary outcomes (3)
Evaluation of transcriptomic differences
Evaluation of transcriptomic differences between tissues or cells from the healthy mucosa compared to those from the primary or metastatic tumor: sequencing of mRNA in the two types of mucosa and comparison of mRNA expression profiles between the latter.
Measured: At 5 years
Evaluation of proteomic differences
Evaluation of proteomic differences between tissues or cells from the healthy mucosa in comparison to those from the primary tumor by:
multiplexed immunodetection in situ in tissues detection and dosage of proteins in culture supernatants (ELISA), in a co-culture model between cancer cells and autologous T cells, with or without modulation of a pathway targeting the T lymphocyte response by immunotherapy.
Measured: At 5 years
Evaluation of the T Cell Receptor (TCR) repertoire
Evaluation of the TCR repertoire by sequencing, carried out from:
patient blood, DNA from cancerous tissues and healthy mucosa DNA from the co-culture between cancer cells and autologous T cells, with or without modulation of a pathway targeting the T lymphocyte response by immunotherapy
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435689
- Sponsor's protocol ID
- APHP231721
- Acronym
- I-COMET
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude et Modulation de la réponse Immunitaire Dans Les Cancers COlorectaux Primaires et METastatiques
- ClinicalTrials.gov ID
- NCT06435689
- Acronym / sponsor ID
- I-COMET / APHP231721
- Conditions
- Colon Cancer, Peritoneal Carcinoma
- Keywords
- Organoids, T-cells, Metastasis, Immunotherapies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2039 (estimated)
- First posted
- 30 May 2024 (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 cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). Recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. Understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. Recently, the consensus molecular classification of CRC confirmed the importance of the immune response in CRC by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. However, immunotherapies are effective for only a minority of patients with metastatic CRC. Indeed, anti Programmed cell Death 1 (anti-PD-1), -PD-L1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (MSI), which only represents 5% of metastatic CRCs.
Thus, the aim of this study is to better understand the role of the immune system on the development of CRC and its possible modulation to treat or prevent metastatic recurrences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers | – | Other: Sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers
Key inclusion criteria (3 listed)
- Male or female 18 years of age or older
- Diagnosis of colorectal adenocarcinoma
- Scheduled resection of tumor and/or metastasis(es)
Key exclusion criteria (9 listed)
- Patient's opposition to research
- Patients under guardianship
- The following situations
- Pregnant or breast-feeding women.
- HIV-positive patients.
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 |
|---|---|---|
| SamplingBlood and surgical specimen sampling the day of surgery | Other | Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers |
Primary outcome
Effectiveness of immunotherapies in a co-culture model
Time frame: At 1 year
Characterize effective immunotherapies in colorectal cancers by demonstrating their effectiveness in a co-culture model between cancer cells and autologous T cells.
3 secondary outcomes
Evaluation of transcriptomic differences
Time frame: At 5 years
Evaluation of proteomic differences
Time frame: At 5 years
Evaluation of the T Cell Receptor (TCR) repertoire
Time frame: At 5 years
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 30 May 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Peritoneal Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 3 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: opening soon, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Thomas Aparicio, Pr (142499597 ext. +33, thomas.aparicio@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of immunotherapies in a co-culture model (time frame: At 1 year). 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 30 May 2024.