Non Metastatic Colorectal CancerNCT04938986
Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer
A study testing IMMUNOSCORE® in people with Non Metastatic Colorectal Cancer, run by Hospital St. Joseph, Marseille, France at 2 sites in France.
Trial summary
Evaluate the patient care recommandation induced by the IMMUNOSCORE® result Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Metastatic Colorectal Cancer
- What is being tested?
- IMMUNOSCORE®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Apr 2022to Apr 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 inclusive;
- histologically confirmed colon adenocarcinoma;
- having undergone a curative resection of stage I, II or III colorectal cancer;
- diagnosed T1 / T2 / T3 / T4 and N0 / N1 / N2;
- eligible to receive 6 months of adjuvant chemotherapy;
- having given free, informed and written consent;
- agreeing to the use of a tumor sample for research purposes;
- being affiliated to a social security system.
Who cannot join
- pregnant or breastfeeding women
- legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent or completing the study.
- history of other solid tumor within 3 years before inclusion, with the exception of in-situ cancer of the cervix and skin cancers (basal or squamous) treated and controlled
- person subject to a safeguard measure.
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, 2 recruiting
- Not yet recruiting
Hôpital Européen
Marseille, 13003
Yves RINALDI
- Recruiting
Hopital Saint Joseph
Marseille, 13008
Hervé PERRIER
About this study
Official title: Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer : Prospective Cohort Comparing the Recommandation for Patient Care According to the Immunoscore® With the Standard Care Decision.
Evaluate the patient care recommandation induced by the IMMUNOSCORE® result
- Conditions
- Non Metastatic Colorectal Cancer
- Being tested
- IMMUNOSCORE®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMMUNOSCORE®Diagnostic test
recommendation for patient care according to the result of the IMMUNOSCORE®
| Study group | Role | What they receive |
|---|---|---|
| IMMUNOSCORE® | Experimental | Not described Receives: Diagnostic Test: IMMUNOSCORE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases where the recommendations for patient care according to the Immunoscore® are considered beneficial compared to the standard care decision
Measured: 5 years
Secondary outcomes (4)
Replication error (RER) phenotype
Number of cases where the Immunoscore® resultat is inconsistent with the RER phenotype
Measured: 6 and 9 months
KRAS, NRAS and BRAF mutations
Number of cases where the Immunoscore® resultat is inconsistent with the KRAS, NRAS and BRAF mutations
Measured: 6 and 9 months
Ratio of ciruclating tumor DNA level
Number of cases where the Immunoscore® resultat is inconsistent with the ratio of ciruclating tumor DNA level
Measured: 6 and 9 months
Actual survival (patient alive without recurrence, alive with recurrence, dead)
Number of cases where the Immunoscore® resultat is inconsistent with the actual survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start4 Apr 2022
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Metastatic Colorectal CancerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé PERRIER, M.D, Principal investigator, Hopital Saint Joseph MarseilleYves RINALDI, M.D, Principal investigator, Hopital Européen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938986
- Sponsor's protocol ID
- PPC-IS
- Status last verified
- Apr 2022
- First submitted
- 22 Jun 2021
- Last updated
- 13 Apr 2022
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer : Prospective Cohort Comparing the Recommandation for Patient Care According to the Immunoscore® With the Standard Care Decision.
- ClinicalTrials.gov ID
- NCT04938986
- Acronym / sponsor ID
- PPC-IS
- Conditions
- Non Metastatic Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 25 Jun 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.
Evaluate the patient care recommandation induced by the IMMUNOSCORE® result
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMMUNOSCORE® | Experimental | Diagnostic Test: IMMUNOSCORE® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age between 18 and 80 inclusive;
- histologically confirmed colon adenocarcinoma;
- having undergone a curative resection of stage I, II or III colorectal cancer;
- diagnosed T1 / T2 / T3 / T4 and N0 / N1 / N2;
- eligible to receive 6 months of adjuvant chemotherapy;
Key exclusion criteria (4 listed)
- pregnant or breastfeeding women
- legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent or completing the study.
- history of other solid tumor within 3 years before inclusion, with the exception of in-situ cancer of the cervix and skin cancers (basal or squamous) treated and controlled
- person subject to a safeguard measure.
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 |
|---|---|---|
| IMMUNOSCORE®recommendation for patient care according to the result of the IMMUNOSCORE® | Diagnostic test | IMMUNOSCORE® |
Primary outcome
Number of cases where the recommendations for patient care according to the Immunoscore® are considered beneficial compared to the standard care decision
Time frame: 5 years
4 secondary outcomes
Replication error (RER) phenotype
Time frame: 6 and 9 months
KRAS, NRAS and BRAF mutations
Time frame: 6 and 9 months
Ratio of ciruclating tumor DNA level
Time frame: 6 and 9 months
Actual survival (patient alive without recurrence, alive with recurrence, dead)
Time frame: 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 13 Apr 2022.
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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.
Hervé PERRIER, M.D principal investigator
Hopital Saint Joseph Marseille
Yves RINALDI, M.D principal investigator
Hopital Européen Marseille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMMUNOSCORE® in people with Non Metastatic Colorectal Cancer, run by Hospital St. Joseph, Marseille, France 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 8 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 13 Apr 2022. 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 Cécile BIELMANN (04 88 73 10 70, cbielmann@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases where the recommendations for patient care according to the Immunoscore® are considered beneficial compared to the standard care decision (time frame: 5 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 13 Apr 2022.