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

Colonic Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03946033
• Other study ID #: UC-0110/1813
• Secondary ID: 2018-A03339-46
• Status: Withdrawn
• Phase: N/A
• Start date: May 2019
• Est. completion date: February 2021

Study information

• Verified date: August 2019
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	HalioDx

Country where clinical trial is conducted

France, 

References & Publications (1)

Pagès F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Börger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grützmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Léonard 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, Mu?ina 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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