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This is a prospective, multicenter, case-control study. The aim is to develop an optimized algorithm by combining the levels of molecular markers in plasma together with risk factors for developing colorectal cancer and clinical data of patients diagnosed with CRC or AA and healthy individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Individual with no findings or findings not related to neoplasia on colonoscopy | ||
| Advanced Adenoma | Patient diagnosed with advanced adenoma by colonoscopy and confirmed by histology result | ||
| Colorectal Cancer | Patient diagnosed with colorectal cancer by colonoscopy and confirmed by histology result |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Validation | To clinically validate the diagnostic capability of the algorithm for early detection of CRC and AA that combines molecular markers and risk factors | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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This study involves the recruitment of 510 patients as part of a case-control study. Patients who are going to undergo colonoscopy or who are going to undergo surgery for resection of a CRC already diagnosed will be included. They can be symptomatic or asymptomatic, ambulatory, hospitalized or consecutive patients in the Endoscopy Unit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Jimenez | Contact | +34637899149 | mjimenez@amadix.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario Lozano Blesa | Recruiting | Zaragoza | Aragon | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30702491 | Background | Herreros-Villanueva M, Duran-Sanchon S, Martin AC, Perez-Palacios R, Vila-Navarro E, Marcuello M, Diaz-Centeno M, Cubiella J, Diez MS, Bujanda L, Lanas A, Jover R, Hernandez V, Quintero E, Jose Lozano J, Garcia-Cougil M, Martinez-Arranz I, Castells A, Gironella M, Arroyo R. Plasma MicroRNA Signature Validation for Early Detection of Colorectal Cancer. Clin Transl Gastroenterol. 2019 Jan;10(1):e00003. doi: 10.14309/ctg.0000000000000003. | |
| 23267864 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Hospital Universitario de Cruces |
| Recruiting |
| Bilbao |
| Basque Country |
| Spain |
| Policlinica Gipuzkoa Hospital | Completed | Donostia / San Sebastian | Basque Country | Spain |
| Hospital Universitario Marques de Valdecilla | Terminated | Santander | Cantabria | Spain |
| Hospital Universitario de Salamanca | Recruiting | Salamanca | Castille and León | Spain |
| Hospital Sant Rafael | Completed | Barcelona | Catalonia | Spain |
| Hospital Universitario Vall d' Hebron | Completed | Barcelona | Catalonia | Spain |
| MD Anderson Cancer Centre | Active, not recruiting | Madrid | Madrid | Spain |
| Hospital Centro Médico de Asturias | Recruiting | Oviedo | Principality of Asturias | Spain |
| Background |
| Giraldez MD, Lozano JJ, Ramirez G, Hijona E, Bujanda L, Castells A, Gironella M. Circulating microRNAs as biomarkers of colorectal cancer: results from a genome-wide profiling and validation study. Clin Gastroenterol Hepatol. 2013 Jun;11(6):681-8.e3. doi: 10.1016/j.cgh.2012.12.009. Epub 2012 Dec 23. |
| 8247072 | Background | Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701. |
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |