- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03946033
Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer (PROSCORE)
A Prospective Study Assessing Whether Immunoscore Colon Test Impacts the Choice of Adjuvant Chemotherapy, in a Multidisciplinary Meeting, for Treating Non-metastatic Colon Cancer Patients After Curative-intent Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
On previous studies, Immunoscore Colon test identified subgroups of stage II and III colon cancer patients whose Chemotherapy could be adjusted.
The study hypothesis is that Immunoscore Colon Test will modify the therapeutic decision in MM.
With Alpha and Beta at 5% and p0=10% modification rate, the participating investigators need to include 280 participants, 140 in each cohort (stage II and stage III).
Participants will have tumor samples from their curative surgery tested with Immunoscore Colon. When the patients are evaluated in MM, a first therapeutic decision will be taken before disclosing the test result. ICT result will then be communicated and a second decision will be taken.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Blois, France
- Hôpital Simone Veil
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Colmar, France
- Hospices Civils de Colmar
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Dijon, France
- CHU de DIJON
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La Roche-sur-Yon, France
- CHD de Vendee
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Lille, France
- Centre Oscar Lambret
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Limoges, France
- CHU de Limoges
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Lyon, France
- Centre Léon Berard
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Lyon, France
- Hôpital Jean Mermoz
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Marseille, France, 13003
- Hôpital Européen Marseille
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Montpellier, France
- Institut Régional du Cancer de Montpellier
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Nantes, France
- CHU Hôtel-Dieu
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Paris, France
- Hôpital Saint-Louis
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Pessac, France
- CHU de Bordeaux - Haut Lévêque
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Poitiers, France
- CHU De Poitiers
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Pringy, France
- Centre Hospitalier Annecy Genevois
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Reims, France
- CHU de Reims
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Rennes, France
- Centre Eugene Marquis
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Saint-Herblain, France
- Institut de Cancérologie de l'Ouest
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Thonon-les-Bains, France
- Hopital du Leman
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Villejuif, France
- Institut Gustave Roussy
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Villeneuve-d'Ascq, France
- Hopital Prive de Villeneuve d'Ascq
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cytologically/histologically proven colon adenocarcinoma
- non-metastatic cancer
- Stage II or III adenocarcinoma
- Surgical resection of primitive tumor within 6 weeks of multidisciplinary meeting
- No macroscopic or microscopic proof of residual disease during surgery (R0 margins)
- Available surgical material: FFPE tumor samples
- Post-operative adjuvant chemotherapy considered during multidisciplinary meeting
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Patient having signed a written informed consent prior to any trial specific procedures
- Patient affiliated to the social security system or equivalent
Exclusion Criteria:
- Other invasive cancer within 5 years of the colon cancer diagnosis, except for adequately treated basal cell carcinoma or squamous cell skin carcinoma or in sity cervical carcinoma
- Patients for which adjuvant chemotherapy is contra-indicated
- Any previous systemic or loco regional anticancer therapy for the studied colon cancer (e.g. neoadjuvant therapy)
- Patient enrolled or planned to be enrolled in another clinical trial that may influence the therapeutic decision
- Any psychological, social or geographical issue that may hinder the patient's understanding of the study or the study conduct
- Person deprived of liberty or under the authority of a legal guardian
- Person unable to understand the study or to comply with the protocol procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Single arm
All participants are included in the same arm.
Immunoscore Colon Test is applied on a tumor sample and the result is kept secret.
In the Multidisciplinary Meeting evaluating the adjuvant therapy of the participant, a first therapeutic decision is taken, then Immunoscore result will be disclosed and the Multidisciplinary Meeting will take a second decision.
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Immunoscore Colon is a CE-marked in-vitro diagnostic test, allowing the quantification of CD3 and CD8 positive cells in formalin-fixed paraffin-embedded (FFPE) tissue samples of primary colon cancer.
The test uses immunohistochemistry, digital pathology techniques and a dedicated software.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modification rate of adjuvant therapeutic strategy
Time Frame: At the multidisciplinary meeting, up to 6 weeks after the cancer surgery
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Modifications of adjuvant therapy, type and/or duration
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At the multidisciplinary meeting, up to 6 weeks after the cancer surgery
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UC-0110/1813
- 2018-A03339-46 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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