Validation of a Molecular Signature for Early Detection of Colorectal Cancer

NCT06738511 | Completed

• 1 other identifier: AMD-EUC-2016
• Study Type: interventional
• Target: 3,421
• Locations: 2 countries
• Sites: 2

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.

Conditions

Colorectal Cancer Screening; Advanced Adenomas (AA)

Keywords

colon and rectum cancer; in vitro diagnostic; liquid biopsy; screening programme

Outcome Measures

Primary Outcomes (1)

• Demonstrate the diagnosis capacity of molecular signature in plasma samples

  48 months

Secondary Outcomes (1)

• Demonstrate superiority of molecular signature in plasma samples compared with FIT

  48 months

Other Outcomes (1)

• Performance of molecular signature in plasma samples (Diagnostic capability) in cases of false positive or false negatives obtained in FIT

  48 months

Study Arms (1)

Blood and Stool sampling

OTHER

To collect blood sampling (by the medical staff) and stool sampling (by the participant)

Diagnostic Test: blood sampling; Other: stool sampling; Other: colonoscopy

Interventions

blood sampling DIAGNOSTIC_TEST

Molecular signature using plasma sample

Blood and Stool sampling

stool sampling OTHER

Stool sampling (by the participant)

Blood and Stool sampling

colonoscopy OTHER

Colonoscopy will be performed in the course of a screening programme

Blood and Stool sampling

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ADVANCED MARKER DISCOVERY S.L.: lead
• European Union H2020 SME Instrument: collaborator

Study Sites (2)

MVZ für Gastroenterolgie am Bayerischen Platz

Berlin, Germany, 10825, Germany

Location

Narodowy Instytut Onkologii w Warszawie Zakład Profilaktyki Nowotworów

Warsaw, Poland, 02-781, Poland

Location

Related Publications (4)

• 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.

  PMID: 22356323 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.

  PMID: 15353432 BACKGROUND

• Siegel and Jemal. American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Atlanta: American Cancer Society, 2011.

  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.

  PMID: 23012113 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Blood Specimen Collection; Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Laboratory Technicians
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 17, 2024
• Study Start: May 28, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); DE (1)