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WithdrawnNCT03946033PROSCOREUpdated Aug 30, 2019

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

An interventional study of Immunoscore Colon Test in Colonic Neoplasms, sponsored by UNICANCER. Withdrawn at 21 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by UNICANCER · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
Canceled by Immunoscore's manufacturer
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colonic Neoplasms

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Keywords

  • Immunoscore Adjuvant Prospective Colon
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In context

Colonic Neoplasms

1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.

Browse Colonic Neoplasms studies →

Lead sponsor

UNICANCER is the lead sponsor of 219 studies on the registry; 52 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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.

    Diagnostic Test: Immunoscore Colon Test

Interventions

  • Diagnostic testImmunoscore Colon 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.

06

What researchers measure

Primary outcomes

  1. Modification rate of adjuvant therapeutic strategy

    Modifications of adjuvant therapy, type and/or duration

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

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Study locations

21 sites
  • Hôpital Simone Veil
    Blois, France
  • Hospices civils de Colmar
    Colmar, France
  • CHU de Dijon
    Dijon, France
  • CHD de Vendée
    La Roche-sur-Yon, France
  • Centre Oscar Lambret
    Lille, France
  • CHU de Limoges
    Limoges, France
  • Centre Léon Bérard
    Lyon, France
  • Hôpital Jean Mermoz
    Lyon, France
  • Hôpital Européen Marseille
    Marseille, 13003, France
  • Institut Régional du Cancer de Montpellier
    Montpellier, France
  • CHU Hôtel-Dieu
    Nantes, France
  • Hôpital Saint-Louis
    Paris, France
  • CHU de Bordeaux - Haut Lévêque
    Pessac, France
  • CHU de Poitiers
    Poitiers, France
  • Centre Hospitalier Annecy Genevois
    Pringy, France
  • CHU de Reims
    Reims, France
  • Centre Eugène Marquis
    Rennes, France
  • Institut de Cancérologie de l'Ouest
    Saint-Herblain, France
  • Hôpital du Léman
    Thonon-les-Bains, France
  • Institut Gustave Roussy
    Villejuif, France
  • Hôpital privé de Villeneuve d'Ascq
    Villeneuve-d'Ascq, France
08

References and documents

Publications

  • 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. PubMed 29754777 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2019; primary completion for Dec 2020, 19 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2019
First posted
May 10, 2019
StartEst.
May 2019
Primary completionEst.
Dec 2020
CompletionEst.
Feb 2021
Last update
Aug 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03946033
Lead sponsor
UNICANCER
Collaborators
HalioDx
Responsible party
Sponsor
First posted
May 10, 2019
Start date
May 2019 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Feb 2021 (estimated)
Last update
Aug 30, 2019

Study contacts

David Malka, Dr
principal investigator · Gustave Roussy, Cancer Campus, Grand Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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