Cancer of the ColonMACROSWITCHNCT05955196
Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer
An observational study of Cancer of the Colon, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Colon
- What is being tested?
- BLOOD AND TUMOR
- Type of treatment
- Surgery or procedure
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2023to 9 Jan 2027
- How long will I take part?
- 24 Months
- 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: The population studied concerns patients over the age of 18, suffering from colon cancer, undergoing immediate surgery or after chemotherapy.
Who may be able to join
- Patient over 18 years old
- Patient who has signed a consent to participate;
- Patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed;
- Patient affiliated to a social security scheme, or beneficiary of such a scheme
Who cannot join
- Patient who had emergency colon cancer surgery
- Person in an emergency situation or unable to express their consent.
- Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
- Patient unable to submit to the medical follow-up of the trial 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, 13009
GENRE Dominique
33 (0)4 91 22 37 78, drci.up@ipc.unicancer.fr
About this study
Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with greater efficacy and lower toxicity than CD47-targeting antibodies. .
In order to study the activity of CD47-SIRPα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. Tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.
- Conditions
- Cancer of the Colon
- Being tested
- BLOOD AND TUMOR
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOD AND TUMORProcedure or surgery
sampling of 24 ml of peripheral blood and samples of colon cancers with healthy tissue in parallel on the surgery piece
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample
the capacity to establish patient-derived organoids from tumor and adjacent normal tissue will be evaluated using a histology score evaluating and comparing primary and organoid sample characteristics.
Measured: 18 months from study launch
Secondary outcomes (3)
Establishment of a validated cryobank of patient derived organoids (minimum n=30)
the capacity to establish a cryobank of patient-derived organoids from tumor and adjacent normal tissue will be evaluated using a growth score evaluating and comparing organoid sample characteristics pre- and post-cryopreservation and amplification through 4 passages.
Measured: 18 months from study launch
Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form
Measured: 48 month
To assess the effect of immunotherapy on the antitumor activity of autologous T cells from peripheral blood samples using tumor viability measurements (cell titer glo, FACS)
Measured: 48 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start9 Jan 2023
- Primary completion9 Jan 2025 (estimated)
- Study completion9 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the ColonStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile de CHAISEMARTIN, MD, Principal investigator, Paoli Calmettes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955196
- Sponsor's protocol ID
- MACROSWITCH-IPC 2021-083
- Acronym
- MACROSWITCH
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2023
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer
- ClinicalTrials.gov ID
- NCT05955196
- Acronym / sponsor ID
- MACROSWITCH / MACROSWITCH-IPC 2021-083
- Conditions
- Cancer of the Colon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Jan 2025 (estimated)
- Study completion
- 9 Jan 2027 (estimated)
- First posted
- 21 Jul 2023 (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.
Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with greater efficacy and lower toxicity than CD47-targeting antibodies. .
In order to study the activity of CD47-SIRPα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. Tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied concerns patients over the age of 18, suffering from colon cancer, undergoing immediate surgery or after chemotherapy.
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Patient who has signed a consent to participate;
- Patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed;
- Patient affiliated to a social security scheme, or beneficiary of such a scheme
Key exclusion criteria (4 listed)
- Patient who had emergency colon cancer surgery
- Person in an emergency situation or unable to express their consent.
- Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
- Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons
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 AND TUMORsampling of 24 ml of peripheral blood and samples of colon cancers with healthy tissue in parallel on the surgery piece | Procedure or surgery | – |
Primary outcome
Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample
Time frame: 18 months from study launch
the capacity to establish patient-derived organoids from tumor and adjacent normal tissue will be evaluated using a histology score evaluating and comparing primary and organoid sample characteristics.
3 secondary outcomes
Establishment of a validated cryobank of patient derived organoids (minimum n=30)
Time frame: 18 months from study launch
Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form
Time frame: 48 month
To assess the effect of immunotherapy on the antitumor activity of autologous T cells from peripheral blood samples using tumor viability measurements (cell titer glo, FACS)
Time frame: 48 month
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 9 Oct 2024.
- 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.
Cécile de CHAISEMARTIN, MD principal investigator
Paoli Calmettes Institute
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 Cancer of the Colon, 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 4 inclusion and 4 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 9 Oct 2024. 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 Dominique GENRE, MD (+33491223778, 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?
Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample (time frame: 18 months from study launch). 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 9 Oct 2024.