ClinicalTrials.gg
RecruitingNCT04938986Updated Apr 13, 2022

Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer

An interventional study of IMMUNOSCORE® in Non Metastatic Colorectal Cancer, sponsored by Hospital St. Joseph, Marseille, France. Recruiting at 2 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-13.

Sponsored by Hospital St. Joseph, Marseille, France · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2022; still recruiting 4 years 7 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 581 studies in Colorectal Neoplasms with a site in France — 110 open to participants now, 165 under way, 26 of them phase 3. Colorectal Neoplasms · France.

Planned enrollment
283rd of 463
100 · median 152
Started
2022
with 33 others
No phase
116 of 581
25 open now
Primary completion
2028-04
later than 107 of 164 live
Registered
418th of 581
by date

Among the 581 studies in Colorectal Neoplasms with a site in France, this one is the 283rd largest by planned enrollment of the 463 interventional ones that give a count, is one of 34 that started in 2022, is one of 116 with no phase, reaches primary completion later than 107 of the 164 other live ones, and was the 418th registered.

Colorectal Neoplasms

6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

110 of the 581 studies in Colorectal Neoplasms with a site in France are open now. Recruiting first, the newest first:

105 more — sign in →

All 110 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 581 studies in Colorectal Neoplasms with a site in France, or all of them as a file.
02

Study summary

Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

03

Conditions studied

  • Non Metastatic Colorectal Cancer
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age between 18 and 80 inclusive;
  • 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 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    IMMUNOSCORE®

    Diagnostic Test: IMMUNOSCORE®

Interventions

  • Diagnostic testIMMUNOSCORE®

    recommendation for patient care according to the result of the IMMUNOSCORE®

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Replication error (RER) phenotype

    Number of cases where the Immunoscore® resultat is inconsistent with the RER phenotype

    Time frame: 6 and 9 months

  2. KRAS, NRAS and BRAF mutations

    Number of cases where the Immunoscore® resultat is inconsistent with the KRAS, NRAS and BRAF mutations

    Time frame: 6 and 9 months

  3. Ratio of ciruclating tumor DNA level

    Number of cases where the Immunoscore® resultat is inconsistent with the ratio of ciruclating tumor DNA level

    Time frame: 6 and 9 months

  4. Actual survival (patient alive without recurrence, alive with recurrence, dead)

    Number of cases where the Immunoscore® resultat is inconsistent with the actual survival

    Time frame: 5 years

07

Study locations

1 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2022 (actual). Primary completion is estimated for Apr 2028, 72 months after the start.

Of 899 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 72 months is above that.

Counting every sponsor, half of 956 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2021
First posted
Jun 25, 2021
StartActual
Apr 4, 2022
Primary completionEst.
Apr 2028
CompletionEst.
Apr 2028
Last update
Apr 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04938986
Lead sponsor
Hospital St. Joseph, Marseille, France
Responsible party
Sponsor
First posted
Jun 25, 2021
Start date
Apr 4, 2022
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Apr 13, 2022

Study contacts

Cécile BIELMANN
Contact
cbielmann@hopital-saint-joseph.fr
04 88 73 10 70
Hervé PERRIER, M.D
principal investigator · Hopital Saint Joseph Marseille
Yves RINALDI, M.D
principal investigator · Hopital Européen Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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