NCT04938986

Brief Summary

Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Apr 2022Apr 2028

First Submitted

Initial submission to the registry

June 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

6 years

First QC Date

June 22, 2021

Last Update Submit

April 12, 2022

Conditions

Non Metastatic Colorectal Cancer

Outcome Measures

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

    5 years

Secondary Outcomes (4)

  • Replication error (RER) phenotype

    6 and 9 months

  • KRAS, NRAS and BRAF mutations

    6 and 9 months

  • Ratio of ciruclating tumor DNA level

    6 and 9 months

  • Actual survival (patient alive without recurrence, alive with recurrence, dead)

    5 years

Study Arms (1)

IMMUNOSCORE®

EXPERIMENTAL
Diagnostic Test: IMMUNOSCORE®

Interventions

IMMUNOSCORE®DIAGNOSTIC_TEST

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

IMMUNOSCORE®

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant or breastfeeding women
  • legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent or completing the study.
  • person subject to a safeguard measure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Européen

Marseille, 13003, France

NOT YET RECRUITING

Hopital Saint Joseph

Marseille, 13008, France

RECRUITING

Study Officials

  • Hervé PERRIER, M.D

    Hopital Saint Joseph Marseille

    PRINCIPAL INVESTIGATOR

  • Yves RINALDI, M.D

    Hopital Européen Marseille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile BIELMANN

CONTACT

04 88 73 10 70cbielmann@hopital-saint-joseph.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 25, 2021

Study Start

April 4, 2022

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

FR(2)