Colorectal CancerNCT03422601
Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment
An observational study of Colorectal Cancer and Stage III Colon Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Stage III Colon Cancer
- What is being tested?
- Immunoscore test
- How many people
- 1,122 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2017to 15 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient of both genders who have underwent surgical resection of stage III colon carcinoma
Who may be able to join
- Patient and tumor characteristics; 3-year clinical Follow-Up
- Data regarding other markers (eg. MSI)
- FFPE blocks available, including core tumor + invasive margin regions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Stage III Colon Cancer
- Being tested
- Immunoscore test
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoscore testDiagnostic test
To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| 3 months treatment | FOLFOX or CAPOX Receives: Diagnostic Test: Immunoscore test | |
| 6 months treatment | FOLFOX or CAPOX Receives: Diagnostic Test: Immunoscore test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start13 Jul 2017
- Primary completion15 Jun 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Collaborators
- HalioDx, Methodology and quality of life unit in oncology, University hospital of Besancon
- Responsible party
- Sponsor
- Investigators
- Thierry ANDRE, MD, Study director, Hôpital Saint Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422601
- Sponsor's protocol ID
- IDEA ancillary study
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32294529
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03422601
- Acronym / sponsor ID
- IDEA ancillary study
- Conditions
- Colorectal Cancer, Stage III Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,122 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Collaborators
- HalioDx, Methodology and quality of life unit in oncology, University hospital of Besancon
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 5 Feb 2018 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months treatment | – | Diagnostic Test: Immunoscore testFOLFOX or CAPOX |
| 6 months treatment | – | Diagnostic Test: Immunoscore testFOLFOX or CAPOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient of both genders who have underwent surgical resection of stage III colon carcinoma
Key inclusion criteria (3 listed)
- Patient and tumor characteristics; 3-year clinical Follow-Up
- Data regarding other markers (eg. MSI)
- FFPE blocks available, including core tumor + invasive margin regions
Key exclusion criteria (3 listed)
- Bouin fixative
- 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
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 testTo identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy. | Diagnostic test | 3 months treatment, 6 months treatment |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 32294529Pages 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thierry ANDRE, MD study director
Hôpital Saint Antoine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Stage III Colon Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422601, which also lists 1 linked publication.
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 27 Feb 2019.