Colorectal Cancer ScreeningNCT06738511
Validation of a Molecular Signature for Early Detection of Colorectal Cancer
A study testing blood sampling, stool sampling and colonoscopy in people with Colorectal Cancer Screening and Advanced Adenomas (AA), run by ADVANCED MARKER DISCOVERY S.L. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening, Advanced Adenomas (AA)
- What is being tested?
- blood sampling, stool sampling and colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,421 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 May 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
MVZ für Gastroenterolgie am Bayerischen Platz
Berlin, Germany, 10825
Poland1 site
Narodowy Instytut Onkologii w Warszawie Zakład Profilaktyki Nowotworów
Warsaw, Poland, 02-781
About this study
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.
- Being tested
- blood sampling, stool sampling, colonoscopy
- Keywords
- colon and rectum cancer, in vitro diagnostic, liquid biopsy, screening programme
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic test
Molecular signature using plasma sample
stool samplingOther
Stool sampling (by the participant)
colonoscopyOther
Colonoscopy will be performed in the course of a screening programme
| Study group | Role | What they receive |
|---|---|---|
| Blood and Stool sampling | Other | To collect blood sampling (by the medical staff) and stool sampling (by the participant) Receives: Diagnostic Test: blood sampling; Other: stool sampling; Other: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the diagnosis capacity of molecular signature in plasma samples
Measured: 48 months
Secondary outcomes (1)
Demonstrate superiority of molecular signature in plasma samples compared with FIT
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start28 May 2018
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADVANCED MARKER DISCOVERY S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738511
- Sponsor's protocol ID
- AMD-EUC-2016
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22356323Lieberman 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.
PubMed 15353432Siegel and Jemal. American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Atlanta: American Cancer Society, 2011.
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.
PubMed 23012113Planelles L, Jimenez-Martinez M, Monsalve-Hernando C, Gonzalez-Garcia S, Castillo L, Janusz K, Devesa CA, Pilonis ND, Arroyo R, Schubert S, Kaminski MF. An Artificial Intelligence-Based Blood Test using protein and miRNA biomarkers for Colorectal Cancer Screening. Clin Transl Gastroenterol. 2026 Oct 6. doi: 10.14309/ctg.0000000000001109. Online ahead of print.
PubMed 42837662
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Molecular Signature for Early Detection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06738511
- Acronym / sponsor ID
- AMD-EUC-2016
- Keywords
- colon and rectum cancer, in vitro diagnostic, liquid biopsy, screening programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,421 participants (actual)
- Lead sponsor
- ADVANCED MARKER DISCOVERY S.L.Industry (pharma, biotech, devices)
- Collaborators
- European Union
- Study start
- 28 May 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood and Stool sampling | Other | Diagnostic Test: blood sampling, Other: stool sampling, Other: colonoscopyTo collect blood sampling (by the medical staff) and stool sampling (by the participant) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingMolecular signature using plasma sample | Diagnostic test | Blood and Stool sampling |
| stool samplingStool sampling (by the participant) | Other | Blood and Stool sampling |
| colonoscopyColonoscopy will be performed in the course of a screening programme | Other | Blood and Stool sampling |
Primary outcome
Demonstrate the diagnosis capacity of molecular signature in plasma samples
Time frame: 48 months
1 secondary outcome
Demonstrate superiority of molecular signature in plasma samples compared with FIT
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 22356323Quintero 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.
- Background: PubMed 15353432Lieberman 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.
- BackgroundSiegel and Jemal. American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Atlanta: American Cancer Society, 2011.
- Background: PubMed 23012113von 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.
- Derived from this study: PubMed 42837662Planelles L, Jimenez-Martinez M, Monsalve-Hernando C, Gonzalez-Garcia S, Castillo L, Janusz K, Devesa CA, Pilonis ND, Arroyo R, Schubert S, Kaminski MF. An Artificial Intelligence-Based Blood Test using protein and miRNA biomarkers for Colorectal Cancer Screening. Clin Transl Gastroenterol. 2026 Oct 6. doi: 10.14309/ctg.0000000000001109. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling, stool sampling and colonoscopy in people with Colorectal Cancer Screening and Advanced Adenomas (AA), run by ADVANCED MARKER DISCOVERY S.L. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the diagnosis capacity of molecular signature in plasma samples (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06738511, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.