Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PRT-K20-080 | Other Grant/Funding Number | French ministry of Health | |
| 2021-018 | Other Grant/Funding Number | French National Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
| Ministry of Health, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
The overall aim of this study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.
The frequency of stage T1 superficial colorectal cancer (CRC) is around 15% and its incidence increases. In France, T1 superficial CCR is mostly treated with endoscopic submucosal dissection (ESD), offering potentially curative, organ-preserving treatment. The presence of pejorative histological criteria (eg. poor differentiation, budding, lymphovascular invasion), detected in about 50% of the tumors, leads to a secondary colectomy or rectal resection with postoperative complications and significant digestive, urological, and sexual functional sequelae. Strikingly, secondary surgical resection is performed in excess in 70 to 80% of the cases, given that no tumor is evidence in the colon and draining lymph nodes. Organ preservation (no secondary surgery) could be offered to a larger number of patients if biomarkers could complete the histological evaluation to better predict metastatic extension to lymph nodes.
Our team showed that the type, density, and location of immune cells in CRC strongly correlated with patients' survival at all disease stages. Our team created an "Immunoscore" (IS) assay, based on CD3+ and cytotoxic CD8+ T-cell densities determined by digital pathology in the tumor and its invasive margin. The robustness and prognostic performance of IS was validated in CRC . Sub-analysis of T1 tumors was not possible (only 31 cases) and tumor specimens did not result from endoscopic resection.
The objective of the study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of patients with stage T1 CRC treated by primary endoscopic resection. | Secondary surgery is performed in patients with pejorative histopathologic feature(s) of the tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoscore Colon Test | Diagnostic Test | Immunoscore Colon is an 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 image analysis software to determine CD3+ and CD8 + cell densities in the tumor ant in the invasive margin of the tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| Lymph node invasion rate | Impact of Immunoscore stratification on lymph node invasion rate in patients with secondary surgery | time of histological examination of the surgical specimen |
| Measure | Description | Time Frame |
|---|---|---|
| Lymph node invasion rate | Impact of Immunoscore stratification combined to Histological risk factors on lymph node invasion rate | time of histological examination of the surgical specimen |
| Microenvironnement Immunologic parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
French multi-institutional cohort of patients with stage T1 CRC treated by primary endoscopic resection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Touria El Aamri | Contact | touria.el-aamri@aphp.fr | ||
| Yvann Frigout | Contact | yvann.frigout@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Franck Pagès, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP - hôpital européen Georges-Pompidou | Paris | 75015 | France |
| 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. | |
Not provided
Not provided
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol could be shared for the purpose of a metaanalysis.
One year after the last publication
Data sharing must be accepted by the sponsor and the PI concerned. Teams wishing to obtain IPD must meet the sponsor and PI team to present their purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.
If all or part of the database is shared with countries outside the European Union for a future purpose, the contract between the sponsor and the recipient of the data that will guaranty levels of protection at least equivalent to those provided by EU regulation.
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Assessment of Immunological features measured by RNA sequencing on tumor samples.
| Up to 3 years |
| Molecular profile of the tumor | Assessment of molecular profile of the tumor by transcriptomic profile measured by RNAseq. CMS classification will be determined | Up to 3 years |
| Background |
| Mlecnik B, Lugli A, Bindea G, Marliot F, Bifulco C, Lee JJ, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Borger E, Hartmann A, Geppert CI, Kolwelter J, Merkel S, Grutzmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Leonard D, Remue C, Wang J, 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, Lafontaine L, Maby P, Majdi A, Hijazi A, El Sissy C, Kirilovsky A, Berger A, Lagorce C, Paustian C, Ballesteros-Merino C, Dijkstra J, van de Water C, Vliet SVL, 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, Patel P, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Fox BA, Pages F, Galon J. Multicenter International Study of the Consensus Immunoscore for the Prediction of Relapse and Survival in Early-Stage Colon Cancer. Cancers (Basel). 2023 Jan 8;15(2):418. doi: 10.3390/cancers15020418. |
| 16371631 | Background | Pages F, Berger A, Camus M, Sanchez-Cabo F, Costes A, Molidor R, Mlecnik B, Kirilovsky A, Nilsson M, Damotte D, Meatchi T, Bruneval P, Cugnenc PH, Trajanoski Z, Fridman WH, Galon J. Effector memory T cells, early metastasis, and survival in colorectal cancer. N Engl J Med. 2005 Dec 22;353(25):2654-66. doi: 10.1056/NEJMoa051424. |
| 17008531 | Background | Galon J, Costes A, Sanchez-Cabo F, Kirilovsky A, Mlecnik B, Lagorce-Pages C, Tosolini M, Camus M, Berger A, Wind P, Zinzindohoue F, Bruneval P, Cugnenc PH, Trajanoski Z, Fridman WH, Pages F. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science. 2006 Sep 29;313(5795):1960-4. doi: 10.1126/science.1129139. |
| 19858404 | Background | Pages F, Kirilovsky A, Mlecnik B, Asslaber M, Tosolini M, Bindea G, Lagorce C, Wind P, Marliot F, Bruneval P, Zatloukal K, Trajanoski Z, Berger A, Fridman WH, Galon J. In situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer. J Clin Oncol. 2009 Dec 10;27(35):5944-51. doi: 10.1200/JCO.2008.19.6147. Epub 2009 Oct 26. |
| 21245428 | Background | Mlecnik B, Tosolini M, Kirilovsky A, Berger A, Bindea G, Meatchi T, Bruneval P, Trajanoski Z, Fridman WH, Pages F, Galon J. Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction. J Clin Oncol. 2011 Feb 20;29(6):610-8. doi: 10.1200/JCO.2010.30.5425. Epub 2011 Jan 18. |
| 32897827 | Background | Mlecnik B, Bifulco C, Bindea G, Marliot F, Lugli A, Lee JJ, 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, Lafontaine L, Bruni D, Lanzi A, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Paustian C, 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, Fox BA, Pages F, Galon J. Multicenter International Society for Immunotherapy of Cancer Study of the Consensus Immunoscore for the Prediction of Survival and Response to Chemotherapy in Stage III Colon Cancer. J Clin Oncol. 2020 Nov 1;38(31):3638-3651. doi: 10.1200/JCO.19.03205. Epub 2020 Sep 8. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |