Clinical trial NCT06738511: Validation of a Molecular Signature for Early Detection of Colorectal Cancer
Official title: Validation of a Molecular Signature for Early Detection of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Advanced Adenomas (AA)
Keywords: colon and rectum cancer
in vitro diagnostic
liquid biopsy
screening programme
Lead sponsor: ADVANCED MARKER DISCOVERY S.L.
Sponsor class: INDUSTRY
Collaborators: name: European Union H2020 SME Instrument
First posted: 2024-12-17
Enrollment: 3421
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Participants between the ages of 50 and 75 (both included) at the time of informed consent signed. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
* Participants referred to the gastroenterology service who are going to undertake colonoscopy as a regular procedure for screening setting.
* Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or older with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).

Exclusion Criteria:

* Participants between the ages of 50 and 75 (both included) at the time of Informed consent signature. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
* Participants who have been diagnosed with CRC. The diagnosis must be subsequently confirmed by biopsy or surgery and pathological anatomy analysis during the study.

Primary outcomes:
measure: Demonstrate the diagnosis capacity of molecular signature in plasma samples
timeFrame: 48 months
Secondary outcomes:
measure: Demonstrate superiority of molecular signature in plasma samples compared with FIT
timeFrame: 48 months
Other outcomes:
measure: Performance of molecular signature in plasma samples (Diagnostic capability) in cases of false positive or false negatives obtained in FIT
timeFrame: 48 months
Locations:
city: Berlin
country: Germany
facility: MVZ für Gastroenterolgie am Bayerischen Platz
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii w Warszawie Zakład Profilaktyki Nowotworów
Study officials:
References:
citation: 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.
citation: 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.
citation: Siegel and Jemal. American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Atlanta: American Cancer Society, 2011.
citation: 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.