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| Name | Class |
|---|---|
| European Union H2020 SME Instrument | UNKNOWN |
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The goal of this Multicentre and international prospective study is to validate a molecular signature using plasma samples in average-risk population for colorectal cancer who undergo colonoscopy in a screening setting.
The main question it aims to answer is:
Does molecular signature in plasma sample have higher diagnostic accuracy than FIT for early detection of colorectal cancer? Participants who already have a colonoscopy as part of their regular medical care for colorectal cancer screening will provide a stool sample and a plasma sample.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood and Stool sampling | Other | To collect blood sampling (by the medical staff) and stool sampling (by the participant) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Diagnostic Test | Molecular signature using plasma sample |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the diagnosis capacity of molecular signature in plasma samples | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate superiority of molecular signature in plasma samples compared with FIT | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of molecular signature in plasma samples (Diagnostic capability) in cases of false positive or false negatives obtained in FIT | 48 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MVZ für Gastroenterolgie am Bayerischen Platz | Berlin | Germany | 10825 | Germany | ||
| Narodowy Instytut Onkologii w Warszawie Zakład Profilaktyki Nowotworów |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22356323 | Background | Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895. | |
| 15353432 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Laboratory Technicians
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| stool sampling |
| Other |
Stool sampling (by the participant) |
|
| colonoscopy | Other | Colonoscopy will be performed in the course of a screening programme |
|
| Warsaw |
| Poland |
| 02-781 |
| Poland |
| Background |
| Lieberman D. Colonoscopy: as good as gold? Ann Intern Med. 2004 Sep 7;141(5):401-3. doi: 10.7326/0003-4819-141-5-200409070-00018. No abstract available. |
| Background | Siegel and Jemal. American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Atlanta: American Cancer Society, 2011. |
| 23012113 | Background | von Karsa L, Patnick J, Segnan N. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Executive summary. Endoscopy. 2012 Sep;44 Suppl 3:SE1-8. doi: 10.1055/s-0032-1309822. Epub 2012 Sep 25. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D019060 | Minimally Invasive Surgical Procedures |