- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04150081
Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer (EpiT1)
Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer: a Population-based Cohort Study
The implementation of population screening programs for colorectal cancer (CRC) has led to a considerable increase in the prevalence T1 CRC originating on polyps amenable by endoscopy. The benefits of secondary oncological surgery in terms of disease free survival are not well established.
Hypothesis: The characteristics of the individuals and the polyp (endoscopic, histological) should allow us to discriminate T1 CRCs that may benefit from secondary surgery from those that only require local treatment. With the current criteria, the management of patients with T1 CRC is suboptimal since a high proportion of patients are refered for unnecessary surgeries without a clear benefit in terms of survival. Molecular signatures can help to discriminate those patients with good prognosis that do not require secondary surgery nor cancer related follow up.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona, España, 08036
- María Pellisé. MD. PhD.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- All patients diagnosed with pT1 CRC will be included, regardless of endoscopic features, treatment received and lymph node staging
Exclusion Criteria:
- CRC with other histology than adenocarcinoma
- Patients with hereditary syndromes of CRC (Lynch syndrome, classical familial adenomatous polyposis) or inflammatory bowel disease.
- Synchronous CRC
- Metachronous CRC in the previous 5 years
- Patients with metastatic neoplastic disease at the time of diagnosis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall survival
Periodo de tiempo: 1 year
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Evaluate the effect of surgery and local (endoscopic) treatment on overall survival (expressed in months)
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1 year
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Disease free survival
Periodo de tiempo: 1 year
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Evaluate the effect of surgery and local (endoscopic) treatment on disease free survival (expressed in months)
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1 year
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Develop a predictive model of the probability of receiving surgical treatment
Periodo de tiempo: 1 year
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Determine factors associated with the choice of primary treatment and final treatment (endoscopic, primary surgery or secondary surgery) and to develop a predictive model that allow discriminate individuals with high probability of receiving surgical treatment
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1 year
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Validation of molecular signatures
Periodo de tiempo: 2 years
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Evaluate the validity of molecular signatures based on mRNA and miRNA (determined in endoscopic samples) for prediction lymph node metastasis
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Prognosis
Periodo de tiempo: 1 year
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Determine the prognosis of patients with pT1CRC in relation to the treatment received (local, primary surgery or secondary surgery)
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1 year
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Risk of lymph node metastasis
Periodo de tiempo: 1 year
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Evaluate the factors of the individual and the polyp that are associated with lymph node metastasis
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1 year
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Concordance of histological evaluation
Periodo de tiempo: 2 years
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Evaluate the inter-intraexplorer concordance of the pathologists for the histological staging criteria.
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2 years
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T1 CRC in screening program
Periodo de tiempo: 1 year
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Compare the characteristics of the T1 CRCs diagnosed within a population screening program and outside it.
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1 year
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Proportion of adverse events
Periodo de tiempo: 1 year
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Evaluate the proportion of adverse effects after endoscopic or surgical treatment
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1 year
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Sensitivity and specificity of follow-up tests
Periodo de tiempo: 1 year
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To evaluate the performances of the different tests (CT, US, blood markers, colonoscopy) during follow up for detecting recurrence
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1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Beaton C, Twine CP, Williams GL, Radcliffe AG. Systematic review and meta-analysis of histopathological factors influencing the risk of lymph node metastasis in early colorectal cancer. Colorectal Dis. 2013 Jul;15(7):788-97. doi: 10.1111/codi.12129.
- Benson AB, Venook AP, Al-Hawary MM, Cederquist L, Chen YJ, Ciombor KK, Cohen S, Cooper HS, Deming D, Engstrom PF, Garrido-Laguna I, Grem JL, Grothey A, Hochster HS, Hoffe S, Hunt S, Kamel A, Kirilcuk N, Krishnamurthi S, Messersmith WA, Meyerhardt J, Miller ED, Mulcahy MF, Murphy JD, Nurkin S, Saltz L, Sharma S, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Wuthrick E, Gregory KM, Freedman-Cass DA. NCCN Guidelines Insights: Colon Cancer, Version 2.2018. J Natl Compr Canc Netw. 2018 Apr;16(4):359-369. doi: 10.6004/jnccn.2018.0021.
- Williams JG, Pullan RD, Hill J, Horgan PG, Salmo E, Buchanan GN, Rasheed S, McGee SG, Haboubi N; Association of Coloproctology of Great Britain and Ireland. Management of the malignant colorectal polyp: ACPGBI position statement. Colorectal Dis. 2013 Aug;15 Suppl 2:1-38. doi: 10.1111/codi.12262. No abstract available.
- Glynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rodel C, Cervantes A, Arnold D; ESMO Guidelines Committee. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv22-iv40. doi: 10.1093/annonc/mdx224. No abstract available. Erratum In: Ann Oncol. 2018 Oct 1;29(Suppl 4):iv263.
- Ueno H, Mochizuki H, Hashiguchi Y, Shimazaki H, Aida S, Hase K, Matsukuma S, Kanai T, Kurihara H, Ozawa K, Yoshimura K, Bekku S. Risk factors for an adverse outcome in early invasive colorectal carcinoma. Gastroenterology. 2004 Aug;127(2):385-94. doi: 10.1053/j.gastro.2004.04.022.
- Logan RF, Patnick J, Nickerson C, Coleman L, Rutter MD, von Wagner C; English Bowel Cancer Screening Evaluation Committee. Outcomes of the Bowel Cancer Screening Programme (BCSP) in England after the first 1 million tests. Gut. 2012 Oct;61(10):1439-46. doi: 10.1136/gutjnl-2011-300843. Epub 2011 Dec 7.
- Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, Hotta K, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kinugasa Y, Murofushi K, Nakajima TE, Oka S, Tanaka T, Taniguchi H, Tsuji A, Uehara K, Ueno H, Yamanaka T, Yamazaki K, Yoshida M, Yoshino T, Itabashi M, Sakamaki K, Sano K, Shimada Y, Tanaka S, Uetake H, Yamaguchi S, Yamaguchi N, Kobayashi H, Matsuda K, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020 Jan;25(1):1-42. doi: 10.1007/s10147-019-01485-z. Epub 2019 Jun 15.
- Belderbos TD, van Erning FN, de Hingh IH, van Oijen MG, Lemmens VE, Siersema PD. Long-term Recurrence-free Survival After Standard Endoscopic Resection Versus Surgical Resection of Submucosal Invasive Colorectal Cancer: A Population-based Study. Clin Gastroenterol Hepatol. 2017 Mar;15(3):403-411.e1. doi: 10.1016/j.cgh.2016.08.041. Epub 2016 Sep 5.
- Hassan C, Zullo A, Risio M, Rossini FP, Morini S. Histologic risk factors and clinical outcome in colorectal malignant polyp: a pooled-data analysis. Dis Colon Rectum. 2005 Aug;48(8):1588-96. doi: 10.1007/s10350-005-0063-3.
- Yoda Y, Ikematsu H, Matsuda T, Yamaguchi Y, Hotta K, Kobayashi N, Fujii T, Oono Y, Sakamoto T, Nakajima T, Takao M, Shinohara T, Fujimori T, Kaneko K, Saito Y. A large-scale multicenter study of long-term outcomes after endoscopic resection for submucosal invasive colorectal cancer. Endoscopy. 2013 Sep;45(9):718-24. doi: 10.1055/s-0033-1344234. Epub 2013 Aug 5.
- Lopez A, Bouvier AM, Jooste V, Cottet V, Romain G, Faivre J, Manfredi S, Lepage C. Outcomes following polypectomy for malignant colorectal polyps are similar to those following surgery in the general population. Gut. 2019 Jan;68(1):111-117. doi: 10.1136/gutjnl-2016-312093. Epub 2017 Oct 26.
- Ozawa T, Kandimalla R, Gao F, Nozawa H, Hata K, Nagata H, Okada S, Izumi D, Baba H, Fleshman J, Wang X, Watanabe T, Goel A. A MicroRNA Signature Associated With Metastasis of T1 Colorectal Cancers to Lymph Nodes. Gastroenterology. 2018 Mar;154(4):844-848.e7. doi: 10.1053/j.gastro.2017.11.275. Epub 2017 Dec 2.
- Backes Y, de Vos Tot Nederveen Cappel WH, van Bergeijk J, Ter Borg F, Schwartz MP, Spanier BWM, Geesing JMJ, Kessels K, Kerkhof M, Groen JN, Wolfhagen FHJ, Seerden TCJ, van Lelyveld N, Offerhaus GJA, Siersema PD, Lacle MM, Moons LMG. Risk for Incomplete Resection after Macroscopic Radical Endoscopic Resection of T1 Colorectal Cancer: A Multicenter Cohort Study. Am J Gastroenterol. 2017 May;112(5):785-796. doi: 10.1038/ajg.2017.58. Epub 2017 Mar 21.
- Richards CH, Ventham NT, Mansouri D, Wilson M, Ramsay G, Mackay CD, Parnaby CN, Smith D, On J, Speake D, McFarlane G, Neo YN, Aitken E, Forrest C, Knight K, McKay A, Nair H, Mulholland C, Robertson JH, Carey FA, Steele R; Scottish Surgical Research Group. An evidence-based treatment algorithm for colorectal polyp cancers: results from the Scottish Screen-detected Polyp Cancer Study (SSPoCS). Gut. 2018 Feb;67(2):299-306. doi: 10.1136/gutjnl-2016-312201. Epub 2016 Oct 27.
- Overwater A, Kessels K, Elias SG, Backes Y, Spanier BWM, Seerden TCJ, Pullens HJM, de Vos Tot Nederveen Cappel WH, van den Blink A, Offerhaus GJA, van Bergeijk J, Kerkhof M, Geesing JMJ, Groen JN, van Lelyveld N, Ter Borg F, Wolfhagen F, Siersema PD, Lacle MM, Moons LMG; Dutch T1 CRC Working Group. Endoscopic resection of high-risk T1 colorectal carcinoma prior to surgical resection has no adverse effect on long-term outcomes. Gut. 2018 Feb;67(2):284-290. doi: 10.1136/gutjnl-2015-310961. Epub 2016 Nov 3.
- Oka S, Tanaka S, Saito Y, Iishi H, Kudo SE, Ikematsu H, Igarashi M, Saitoh Y, Inoue Y, Kobayashi K, Hisabe T, Tsuruta O, Sano Y, Yamano H, Shimizu S, Yahagi N, Watanabe T, Nakamura H, Fujii T, Ishikawa H, Sugihara K; Colorectal Endoscopic Resection Standardization Implementation Working Group of the Japanese Society for Cancer of the Colon and Rectum, Tokyo, Japan. Local recurrence after endoscopic resection for large colorectal neoplasia: a multicenter prospective study in Japan. Am J Gastroenterol. 2015 May;110(5):697-707. doi: 10.1038/ajg.2015.96. Epub 2015 Apr 7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HCB/2019/0224
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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