Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer
NCT ID: NCT03946033
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2019-05-31
2021-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immunoscore 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HalioDx
INDUSTRY
UNICANCER
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Malka, Dr
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-A03339-46
Identifier Type: OTHER
Identifier Source: secondary_id
UC-0110/1813
Identifier Type: -
Identifier Source: org_study_id