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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03339-46 | Other Identifier | ANSM |
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Canceled by Immunoscore's manufacturer
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| Name | Class |
|---|---|
| HalioDx | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoscore Colon Test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Malka, Dr | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Simone Veil | Blois | France | ||||
| Hospices civils de Colmar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29754777 | Background | 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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Immunoscore Colon Test Result will be disclosed in Multidisciplinary Meeting only after the first therapeutic decision
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|
| 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 |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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