NCT03946033

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Geographic Reach
1 country

21 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

May 7, 2019

Last Update Submit

August 27, 2019

Conditions

Colonic Neoplasms

Keywords

Immunoscore Adjuvant Prospective Colon

Outcome Measures

Primary Outcomes (1)

  • Modification rate of adjuvant therapeutic strategy

    Modifications of adjuvant therapy, type and/or duration

    At the multidisciplinary meeting, up to 6 weeks after the cancer surgery

Study Arms (1)

Single arm

OTHER

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.

Diagnostic Test: Immunoscore Colon Test

Interventions

Immunoscore Colon TestDIAGNOSTIC_TEST

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.

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Hôpital Simone Veil

Blois, France

Location

Hospices civils de Colmar

Colmar, France

Location

CHU de Dijon

Dijon, France

Location

CHD de Vendée

La Roche-sur-Yon, France

Location

Centre Oscar Lambret

Lille, France

Location

CHU de Limoges

Limoges, France

Location

Centre Léon Bérard

Lyon, France

Location

Hôpital Jean Mermoz

Lyon, France

Location

Hôpital Européen Marseille

Marseille, 13003, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, France

Location

CHU Hôtel-Dieu

Nantes, France

Location

Hôpital Saint-Louis

Paris, France

Location

CHU de Bordeaux - Haut Lévêque

Pessac, France

Location

CHU de Poitiers

Poitiers, France

Location

Centre Hospitalier Annecy Genevois

Pringy, France

Location

CHU de Reims

Reims, France

Location

Centre Eugène Marquis

Rennes, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Location

Hôpital du Léman

Thonon-les-Bains, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Hôpital privé de Villeneuve d'Ascq

Villeneuve-d'Ascq, France

Location

Related Publications (1)

  • 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.

    PMID: 29754777BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • David Malka, Dr

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Immunoscore Colon Test Result will be disclosed in Multidisciplinary Meeting only after the first therapeutic decision
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 10, 2019

Study Start

May 1, 2019

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

FR(21)