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

Primary Purpose

Colonic Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immunoscore Colon Test
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Neoplasms focused on measuring Immunoscore Adjuvant Prospective Colon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Simone Veil
  • Hospices civils de Colmar
  • CHU de Dijon
  • CHD de Vendée
  • Centre Oscar Lambret
  • CHU de Limoges
  • Centre Léon Bérard
  • Hôpital Jean Mermoz
  • Hôpital Européen Marseille
  • Institut Régional du Cancer de Montpellier
  • CHU Hôtel-Dieu
  • Hôpital Saint-Louis
  • CHU de Bordeaux - Haut Lévêque
  • CHU de Poitiers
  • Centre Hospitalier Annecy Genevois
  • CHU de Reims
  • Centre Eugène Marquis
  • Institut de Cancérologie de l'Ouest
  • Hôpital du Léman
  • Institut Gustave Roussy
  • Hôpital privé de Villeneuve d'Ascq

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Modification rate of adjuvant therapeutic strategy
Modifications of adjuvant therapy, type and/or duration

Secondary Outcome Measures

Full Information

First Posted
May 7, 2019
Last Updated
August 27, 2019
Sponsor
UNICANCER
Collaborators
HalioDx
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1. Study Identification

Unique Protocol Identification Number
NCT03946033
Brief Title
Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer
Acronym
PROSCORE
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Canceled by Immunoscore's manufacturer
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
HalioDx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Immunoscore Adjuvant Prospective Colon

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Immunoscore Colon Test Result will be disclosed in Multidisciplinary Meeting only after the first therapeutic decision
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Immunoscore Colon Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modification rate of adjuvant therapeutic strategy
Description
Modifications of adjuvant therapy, type and/or duration
Time Frame
At the multidisciplinary meeting, up to 6 weeks after the cancer surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Malka, Dr
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Simone Veil
City
Blois
Country
France
Facility Name
Hospices civils de Colmar
City
Colmar
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHD de Vendée
City
La Roche-sur-Yon
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hôpital Jean Mermoz
City
Lyon
Country
France
Facility Name
Hôpital Européen Marseille
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Institut Régional du Cancer de Montpellier
City
Montpellier
Country
France
Facility Name
CHU Hôtel-Dieu
City
Nantes
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
Facility Name
CHU de Bordeaux - Haut Lévêque
City
Pessac
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Facility Name
Centre Hospitalier Annecy Genevois
City
Pringy
Country
France
Facility Name
CHU de Reims
City
Reims
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Saint-Herblain
Country
France
Facility Name
Hôpital du Léman
City
Thonon-les-Bains
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Facility Name
Hôpital privé de Villeneuve d'Ascq
City
Villeneuve-d'Ascq
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29754777
Citation
Pages F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Borger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grutzmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Leonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Angelova M, Vasaturo A, Maby P, Church SE, Angell HK, Lafontaine L, Bruni D, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Meyers JP, Paustian C, Feng Z, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Musina AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Sargent DJ, Fox BA, Galon J. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139. doi: 10.1016/S0140-6736(18)30789-X. Epub 2018 May 10.
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Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer

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