Colorectal CancerNCT06889844
Observational Cross-reactivity Study for Colorectal Cancer Diagnosis
An observational study of Colorectal Cancer, run by ADVANCED MARKER DISCOVERY S.L. at 5 sites in Spain.
Trial summary
The objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- blood sampling
- How many people
- 250 participants
- Where
- 5 sitesSpain
- Study dates
- 17 Apr 2023to Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled with a only one diagnosis of cancer (no colorectal cancer) or gastrointestinal disease at the time of a consultation within the Oncology, Digestive System, Gastroenterology, Endoscopy or Surgery Service. Patients will be included in a competitive, consecutive and progressive manner by the Centers.
Who may be able to join
- Patients older than 18 years of age at the time of blood sample collection.
- Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form.
- Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease.
Who cannot join
- Patients who have received previous chemotherapy or radiotherapy.
- In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor.
- Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome.
- Patients without appropriate staging or diagnosis.
- Patients with hemolyzed plasma.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 4 recruiting
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, Madrid
- Active, not recruiting
MD Anderson Cancer Centre
Madrid, Madrid
- Recruiting
Hospitales HM de Malaga
Málaga, Andalusia
- Recruiting
Hospital Universitario de Ourense
Ourense, Galicia
- Recruiting
Hospital Centro Médico Asturias
Oviedo, Cantabria
About this study
Official title: Observational Cross-reactivity Study to Evaluate the Specificity of a Blood Test for Colorectal Cancer Diagnosis Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools
The objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is
Does the blood test have a low false positive rate in the main study population?
Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.
- Conditions
- Colorectal Cancer
- Being tested
- blood sampling
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic test
Patients will donate a blood sample for molecular analysis of molecular biomarkers in plasma, which being the only procedure in the study.
| Study group | Role | What they receive |
|---|---|---|
| Cancer or Gastrointestinal Disease | A different types of cancer and gastrointestinal disease will be included in the cohort such as breast cancer, bladder cancer, IBDs, Leukemia and Lung cancer. Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
False Positive Rate
To estimate the false positive rate of the blood-based test in the main population of the study
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start17 Apr 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- ADVANCED MARKER DISCOVERY S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889844
- Sponsor's protocol ID
- AMD-CCR-2022-01
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
PubMed 36856579Herreros-Villanueva M, Duran-Sanchon S, Martin AC, Perez-Palacios R, Vila-Navarro E, Marcuello M, Diaz-Centeno M, Cubiella J, Diez MS, Bujanda L, Lanas A, Jover R, Hernandez V, Quintero E, Jose Lozano J, Garcia-Cougil M, Martinez-Arranz I, Castells A, Gironella M, Arroyo R. Plasma MicroRNA Signature Validation for Early Detection of Colorectal Cancer. Clin Transl Gastroenterol. 2019 Jan;10(1):e00003. doi: 10.14309/ctg.0000000000000003.
PubMed 30702491Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cross-reactivity Study to Evaluate the Specificity of a Blood Test for Colorectal Cancer Diagnosis Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools
- ClinicalTrials.gov ID
- NCT06889844
- Acronym / sponsor ID
- AMD-CCR-2022-01
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- ADVANCED MARKER DISCOVERY S.L.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Mar 2025 (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 objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is
Does the blood test have a low false positive rate in the main study population?
Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer or Gastrointestinal Disease | – | Diagnostic Test: blood samplingA different types of cancer and gastrointestinal disease will be included in the cohort such as breast cancer, bladder cancer, IBDs, Leukemia and Lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled with a only one diagnosis of cancer (no colorectal cancer) or gastrointestinal disease at the time of a consultation within the Oncology, Digestive System, Gastroenterology, Endoscopy or Surgery Service. Patients will be included in a competitive, consecutive and progressive manner by the Centers.
Key inclusion criteria (3 listed)
- Patients older than 18 years of age at the time of blood sample collection.
- Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form.
- Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease.
Key exclusion criteria (5 listed)
- Patients who have received previous chemotherapy or radiotherapy.
- In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor.
- Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome.
- Patients without appropriate staging or diagnosis.
- Patients with hemolyzed plasma.
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 samplingPatients will donate a blood sample for molecular analysis of molecular biomarkers in plasma, which being the only procedure in the study. | Diagnostic test | Cancer or Gastrointestinal Disease |
Primary outcome
False Positive Rate
Time frame: 36 month
To estimate the false positive rate of the blood-based test in the main population of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 36856579Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
- Background: PubMed 30702491Herreros-Villanueva M, Duran-Sanchon S, Martin AC, Perez-Palacios R, Vila-Navarro E, Marcuello M, Diaz-Centeno M, Cubiella J, Diez MS, Bujanda L, Lanas A, Jover R, Hernandez V, Quintero E, Jose Lozano J, Garcia-Cougil M, Martinez-Arranz I, Castells A, Gironella M, Arroyo R. Plasma MicroRNA Signature Validation for Early Detection of Colorectal Cancer. Clin Transl Gastroenterol. 2019 Jan;10(1):e00003. doi: 10.14309/ctg.0000000000000003.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by ADVANCED MARKER DISCOVERY S.L. at 5 sites in Spain.
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 5 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Jimenez (+34637899149, mjimenez@amadix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False Positive Rate (time frame: 36 month). 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 NCT06889844, which also lists 3 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 1 Oct 2025.