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Validation of a Molecular Signature for Early Detection of Colorectal Cancer

NCT ID: NCT06738511

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Screening Advanced Adenomas (AA)

Keywords

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colon and rectum cancer in vitro diagnostic liquid biopsy screening programme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Laboratory Technicians

Study Groups

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Blood and Stool sampling

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

Group Type OTHER

blood sampling

Intervention Type DIAGNOSTIC_TEST

Molecular signature using plasma sample

stool sampling

Intervention Type OTHER

Stool sampling (by the participant)

colonoscopy

Intervention Type OTHER

Colonoscopy will be performed in the course of a screening programme

Interventions

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blood sampling

Molecular signature using plasma sample

Intervention Type DIAGNOSTIC_TEST

stool sampling

Stool sampling (by the participant)

Intervention Type OTHER

colonoscopy

Colonoscopy will be performed in the course of a screening programme

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Union H2020 SME Instrument

UNKNOWN

Sponsor Role collaborator

ADVANCED MARKER DISCOVERY S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MVZ für Gastroenterolgie am Bayerischen Platz

Berlin, Germany, Germany

Site Status

Narodowy Instytut Onkologii w Warszawie Zakład Profilaktyki Nowotworów

Warsaw, Poland, Poland

Site Status

Countries

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Germany Poland

References

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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.

Reference Type BACKGROUND
PMID: 22356323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15353432 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 23012113 (View on PubMed)

Other Identifiers

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AMD-EUC-2016

Identifier Type: -

Identifier Source: org_study_id