Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer (PROSCORE)

August 27, 2019 updated by: UNICANCER

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

Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.

Study Overview

Status

Withdrawn

Conditions

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Blois, France
        • Hôpital Simone Veil
      • Colmar, France
        • Hospices Civils de Colmar
      • Dijon, France
        • CHU de DIJON
      • La Roche-sur-Yon, France
        • CHD de Vendee
      • Lille, France
        • Centre Oscar Lambret
      • Limoges, France
        • CHU de Limoges
      • Lyon, France
        • Centre Léon Berard
      • Lyon, France
        • Hôpital Jean Mermoz
      • Marseille, France, 13003
        • Hôpital Européen Marseille
      • Montpellier, France
        • Institut Régional du Cancer de Montpellier
      • Nantes, France
        • CHU Hôtel-Dieu
      • Paris, France
        • Hôpital Saint-Louis
      • Pessac, France
        • CHU de Bordeaux - Haut Lévêque
      • Poitiers, France
        • CHU De Poitiers
      • Pringy, France
        • Centre Hospitalier Annecy Genevois
      • Reims, France
        • CHU de Reims
      • Rennes, France
        • Centre Eugene Marquis
      • Saint-Herblain, France
        • Institut de Cancérologie de l'Ouest
      • Thonon-les-Bains, France
        • Hopital du Leman
      • Villejuif, France
        • Institut Gustave Roussy
      • Villeneuve-d'Ascq, France
        • Hopital Prive de Villeneuve d'Ascq

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.

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
Modifications of adjuvant therapy, type and/or duration
At the multidisciplinary meeting, up to 6 weeks after the cancer surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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