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出境医 / 临床实验 / Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer (PROSCORE)
Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer (PROSCORE)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colonic Neoplasms | Diagnostic Test: Immunoscore Colon Test | Not Applicable |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Masking Description: | Immunoscore Colon Test Result will be disclosed in Multidisciplinary Meeting only after the first therapeutic decision |
| Primary Purpose: | Diagnostic |
| 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 |
| Estimated Study Start Date : | May 2019 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | February 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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
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.
|
Outcome Measures
Primary Outcome Measures :
- Modification rate of adjuvant therapeutic strategy [ Time Frame: At the multidisciplinary meeting, up to 6 weeks after the cancer surgery ]Modifications of adjuvant therapy, type and/or duration
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Locations
Show 21 study locations
Sponsors and Collaborators
UNICANCER
HalioDx
Investigators
| Principal Investigator: | David Malka, Dr | Gustave Roussy, Cancer Campus, Grand Paris |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||
| First Posted Date ICMJE | May 10, 2019 | ||||
| Last Update Posted Date | August 30, 2019 | ||||
| Estimated Study Start Date ICMJE | May 2019 | ||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Modification rate of adjuvant therapeutic strategy [ Time Frame: At the multidisciplinary meeting, up to 6 weeks after the cancer surgery ] Modifications of adjuvant therapy, type and/or duration
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer | ||||
| Official Title ICMJE | 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 | ||||
| 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. | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Masking Description: Immunoscore Colon Test Result will be disclosed in Multidisciplinary Meeting only after the first therapeutic decision Primary Purpose: Diagnostic
|
||||
| Condition ICMJE | Colonic Neoplasms | ||||
| Intervention ICMJE | 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.
|
||||
| Study Arms ICMJE | 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.
Intervention: Diagnostic Test: Immunoscore Colon Test
|
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| Publications * | 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, Mușină 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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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE |
0 | ||||
| Original Estimated Enrollment ICMJE |
280 | ||||
| Estimated Study Completion Date ICMJE | February 2021 | ||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03946033 | ||||
| Other Study ID Numbers ICMJE | UC-0110/1813 2018-A03339-46 ( Other Identifier: ANSM ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | UNICANCER | ||||
| Study Sponsor ICMJE | UNICANCER | ||||
| Collaborators ICMJE | HalioDx | ||||
| Investigators ICMJE |
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| PRS Account | UNICANCER | ||||
| Verification Date | August 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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