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Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment

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ClinicalTrials.gov Identifier: NCT03422601
Recruitment Status : Active, not recruiting
First Posted : February 5, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
HalioDx
Methodology and quality of life unit in oncology, University hospital of Besancon
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Tracking Information
First Submitted Date January 30, 2018
First Posted Date February 5, 2018
Last Update Posted Date February 27, 2019
Actual Study Start Date July 13, 2017
Estimated Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2018)
disease-free survival (DFS) [ Time Frame: 3 years ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03422601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment
Official Title Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment: an Ancillary Study of IDEA France Study
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.

Detailed Description Adult patients of both genders who have underwent surgical resection of stage III colon carcinoma and randomised to receive a 6-month or 3-month adjuvant therapy with modified FOLFOX 6 or CAPOX in the IDEA France trial.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissues: colon carcinoma and adjacent non-tumor tissues collected in formalin fixed paraffin embedded blocks.
Sampling Method Probability Sample
Study Population Adult patient of both genders who have underwent surgical resection of stage III colon carcinoma
Condition
  • Colorectal Cancer
  • Stage III Colon Cancer
Intervention Diagnostic Test: Immunoscore test
To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.
Study Groups/Cohorts
  • 3 months treatment
    FOLFOX or CAPOX
    Intervention: Diagnostic Test: Immunoscore test
  • 6 months treatment
    FOLFOX or CAPOX
    Intervention: Diagnostic Test: Immunoscore test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 30, 2018)
1122
Original Actual Enrollment Same as current
Estimated Study Completion Date July 15, 2019
Estimated Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03422601
Other Study ID Numbers IDEA ancillary study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party GERCOR - Multidisciplinary Oncology Cooperative Group
Study Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators
  • HalioDx
  • Methodology and quality of life unit in oncology, University hospital of Besancon
Investigators
Study Director: Thierry ANDRE, MD Hôpital Saint Antoine
PRS Account GERCOR - Multidisciplinary Oncology Cooperative Group
Verification Date February 2019