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| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
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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.
The primary objective of the study is to compare the effect of oncological surgery versus local treatment for the management of polyps with T1 CRC in relation to disease-free survival and morbi-mortality of the therapeutic procedure. We will also validate molecular signatures in endoscopic samples for the prediction of lymph node metastasis and survival. Methodology: Clinical Study: Retrospective population-based cohort study that will include baseline clinical and follow up data of more than 1400 T1 CRCs in at least 10 Spanish autonomous communities from 2007 to 2017. A centralized pathological review will be carried out by a group of expert pathologists. Inter and intraobserver variability for histological staging will be assessed. A predictive model will be created to discriminate individuals with high probability of receiving surgical and local treatment. For those patients who have a similar probability range, the results in progression-free survival and adverse events will be compared. Translational phase: A 5miRNAs and 8mRNA signature predictive of lymph node metastasis will be assessed in 200 endoscopic samples and related with prognosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery or Endoscopic treatment | Procedure | All the patients in the cohort will receive surgery o local (endoscopic) treatment, in some cases additional surgical treatment will be performed after an endoscopic primary treatment. This decision will have been taken based on daily clinical practice and does not represent a study intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Evaluate the effect of surgery and local (endoscopic) treatment on overall survival (expressed in months) | 1 year |
| Disease free survival | Evaluate the effect of surgery and local (endoscopic) treatment on disease free survival (expressed in months) | 1 year |
| Develop a predictive model of the probability of receiving surgical treatment | 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 | 1 year |
| Validation of molecular signatures | Evaluate the validity of molecular signatures based on mRNA and miRNA (determined in endoscopic samples) for prediction lymph node metastasis | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prognosis | Determine the prognosis of patients with pT1CRC in relation to the treatment received (local, primary surgery or secondary surgery) | 1 year |
| Risk of lymph node metastasis | Evaluate the factors of the individual and the polyp that are associated with lymph node metastasis |
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Inclusion Criteria:
- All patients diagnosed with pT1 CRC will be included, regardless of endoscopic features, treatment received and lymph node staging
Exclusion Criteria:
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Spanish multicenter observational retrospective cohort study where all cases of pT1 CRC will be included from January 2007 to December 2017. Patients will be included both inside and outside the CCR national screening program.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| María Pellisé. MD. PhD. | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22156981 | Background | 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. | |
| 23848492 | Background |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Tissue samples. A 10μm slice of the FFPE block will be obtained after manual microdissection of the area with cancer. The molecular study will be carried out in patients who have signed a biobank informed consent prior to the start of this study.
| 1 year |
| Concordance of histological evaluation | Evaluate the inter-intraexplorer concordance of the pathologists for the histological staging criteria. | 2 years |
| T1 CRC in screening program | Compare the characteristics of the T1 CRCs diagnosed within a population screening program and outside it. | 1 year |
| Proportion of adverse events | Evaluate the proportion of adverse effects after endoscopic or surgical treatment | 1 year |
| Sensitivity and specificity of follow-up tests | To evaluate the performances of the different tests (CT, US, blood markers, colonoscopy) during follow up for detecting recurrence | 1 year |
| 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. |
| 15300569 | Background | 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. |
| 31203527 | Background | 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. |
| 29632055 | Background | 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. |
| 28881920 | Background | 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. |
| 27609703 | Background | 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. |
| 15937622 | Background | 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. |
| 23331927 | Background | 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. |
| 23918621 | Background | 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. |
| 29074726 | Background | 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. |
| 29199088 | Background | 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. |
| 28323275 | Background | 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. |
| 27789658 | Background | 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. |
| 27811313 | Background | 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. |
| 25848926 | Background | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |