NCT03422601

Brief Summary

The primary objective is to validate that the Immunoscore® test (IS0 to IS4) is able to identify patients with high risk (IS 0-1) of relapse or death whichever occurs first among Stage III patients under oxaliplatin-based adjuvant therapy. Then the prognostic value of Immunoscore® Colon to predict disease free survival (DFS) will be assessed in Stage III patients under Oxaliplatin treatment in each arm of the IDEA trial (6- months and 3-months treatment). Finally, the additive value of the Immunoscore® test to stratify the DFS will be evaluated among standard clinical and biological parameters and tumor features.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,122

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 13, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

January 30, 2018

Last Update Submit

February 26, 2019

Conditions

Colorectal CancerStage III Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • disease-free survival (DFS)

    DFS is defined as the time from randomization to relapse or death, whichever occurred first. Secondary colon cancers are regarded as DFS events, whereas non-colon tumors are to be disregarded in the analysis. Patients with no defined events observed during the follow-up will be censored at the date of last disease evaluation which showed no evidence of relapse, or secondary primary colon cancer.

    3 years

Study Arms (2)

3 months treatment

FOLFOX or CAPOX

Diagnostic Test: Immunoscore test

6 months treatment

FOLFOX or CAPOX

Diagnostic Test: Immunoscore test

Interventions

Immunoscore testDIAGNOSTIC_TEST

To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.

3 months treatment6 months treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patient of both genders who have underwent surgical resection of stage III colon carcinoma

You may qualify if:

  • Patient and tumor characteristics; 3-year clinical Follow-Up
  • Data regarding other markers (eg. MSI)
  • FFPE blocks available, including core tumor + invasive margin regions

You may not qualify if:

  • Bouin fixative
  • Sample type:
  • adjacent FFPE slices (4 μm each) per case (although only one slide is required for CD3 and one for CD8, with center of tumor (CT) and the invasive margin(IM) cut from FFPE blocks no more than 4 months before the Immunoscore® testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Antoine

Paris, France

Location

Related Publications (1)

  • Pages F, Andre T, Taieb J, Vernerey D, Henriques J, Borg C, Marliot F, Ben Jannet R, Louvet C, Mineur L, Bennouna J, Desrame J, Faroux R, Kirilovsky A, Duval A, Laurent-Puig P, Svrcek M, Hermitte F, Catteau A, Galon J, Emile JF. Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France PRODIGE-GERCOR cohort study. Ann Oncol. 2020 Jul;31(7):921-929. doi: 10.1016/j.annonc.2020.03.310. Epub 2020 Apr 12.

    PMID: 32294529DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tissues: colon carcinoma and adjacent non-tumor tissues collected in formalin fixed paraffin embedded blocks.

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Thierry ANDRE, MD

    Hôpital Saint Antoine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 5, 2018

Study Start

July 13, 2017

Primary Completion

June 15, 2019

Study Completion

July 15, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)