Colorectal CancerBEACONNCT07450612
Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
An observational study of Colorectal Cancer and Adenoma Colon, run by San Raffaele University at 4 sites in Italy.
Trial summary
This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenoma Colon, Adenoma Colon Polyp
- What is being tested?
- BEACON
- How many people
- 1,200 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Jan 2024to 15 Aug 2031
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Seven independent cohorts of individuals who belong to one of the following seven: * Lynch syndrome, without any Lynch-syndrome-associated cancer * Lynch syndrome, with one or more Lynch-syndrome-associated cancer(s) * Sporadic colorectal cancer * Sporadic advanced adenoma (at most) * Colonoscopy-negative controls * Treatment-naive blood samples * Post-treatment blood samples
Who may be able to join
- All individuals included in the study need to have had a colonoscopy at the time of blood sampling.
- Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
- Received standard pathological and endoscopic diagnosis and assessment for cohort assignment
Who cannot join
- Lack of informed consent
- Inflammatory bowel disease
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Not yet recruiting
Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital
Milan, Lombardy, 20132
Giulia Martina Cavestro, MD, PhD, cavestro.giuliamartina@hsr.it
Alessandro Mannucci, MD
- Not yet recruiting
Prof Giulia Martina Cavestro, MD PhD
Milan, Lombardy, 20132
Giulia Martina Cavestro, MD, PhD, 0226435508 ext. +39, cavestro.giuliamartina@hsr.it
Marta Puzzono, MD, PhD
- Recruiting
San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit
Milan, Lombardy, 20132
Giulia Martina Cavestro, MD PhD, cavestro.giuliamartina@hsr.it
- Not yet recruiting
Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori
Milan, MI
Marco Vitellaro, MD
About this study
This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.
Read the detailed description
Colorectal cancer (CRC) remains a significant public health burden as the third-most commonly diagnosed and second-deadliest malignancy. While CRC is potentially preventable through the removal of precursor lesions known as advanced adenomas (AAs), current screening modalities have limitations. The fecal immunochemical test (FIT) exhibits reduced sensitivity for early-stage CRC and AAs, primarily lowering mortality rather than incidence. Colonoscopy, while effective, is invasive, costly, and suffers from suboptimal adherence. Additionally, individuals with Lynch syndrome (LS), who carry a pathogenic germline variant in mismatch repair (MMR) genes, lack effective and reliable methods for early-stage detection of non-CRC tumors associated with the syndrome.
The rationale of this study, BEACON/2026, is to develop and validate two blood-based tests to address these clinical gaps. The first is a screening test sensitive to both CRC and AAs to complement existing screening options; the second is a multi-cancer early detection (MCED) test tailored to the LS spectrum. The central hypothesis is that a liquid biopsy approach combining cell-free microRNAs (cf-miRNAs, which are sensitive) and exosome-bound microRNAs (exo-miRNAs, which are specific) can effectively distinguish patients with AAs, CRC, and LS-associated cancers from controls.
This study follows the Early Detection Research Network (EDRN) recommendations for biomarker development, including biomarker discovery, prioritization, training, and independent validation (Phases I through III). The experimental design complies with PROBE recommendations for prospectively collected biospecimens that are blindly evaluated. The procedure involves the collection of peripheral blood to isolate RNA from plasma or serum for reverse transcription, quantitative polymerase chain reaction (RT-qPCR) analysis and machine-learning modeling . This non-invasive approach aims to provide a cost-effective, patient-friendly alternative to improve screening participation and disease monitoring
- Conditions
- Colorectal Cancer, Adenoma Colon, Adenoma Colon Polyp, Colon Adenoma, Colo-rectal Cancer, Colon Disease
- Being tested
- BEACON
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Colonic Diseases, Colorectal Neoplasms, Hereditary Nonpolyposis, Lynch Syndrome II, Lynch syndrome I (site-specific colonic cancer), Turcot syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEACONDiagnostic test
A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples
| Study group | Role | What they receive |
|---|---|---|
| Lynch syndrome, without Lynch-syndrome associated cancers | Individuals with Lynch syndrome, who are free of Lynch-syndrome associated cancers at the time of blood drawing Receives: Diagnostic Test: BEACON | |
| Lynch syndrome, with Lynch-syndrome associated cancers | Individuals with Lynch syndrome, who have one (or more) Lynch-syndrome associated cancer(s) at the time of blood drawing Receives: Diagnostic Test: BEACON | |
| Colorectal cancer | Individuals with sporadic biopsy-proven colorectal cancer, as identified during routine colonoscopy and diagnosed via pathological review Receives: Diagnostic Test: BEACON | |
| Advanced adenoma | Individuals with sporadic advanced adenomas, defined as (i) more than 3 colorectal polyps, (ii) presence of high-grade dysplasia in one or more polyp, or (iii) polyp(s) >10 mm Receives: Diagnostic Test: BEACON | |
| Colonoscopy-negative controls | Individuals whose colonoscopy was negative for colorectal cancer and for advanced colorectal adenomas Receives: Diagnostic Test: BEACON | |
| Pre-treatment samples | Individuals with (i) colorectal cancer, or (ii) advanced adenomas, or (iii) Lynch syndrome associated cancer(s) will have the possibility to participate to a sub-analysis of this study, where their circulating plasma levels of biomarkers will be evaluated prior to resection (treatment-naive) and post-resection (to measure the molecular persistence of the disease after the resection) Receives: Diagnostic Test: BEACON | |
| Post-treatment samples | Individuals with (i) colorectal cancer, or (ii) advanced adenomas, or (iii) Lynch syndrome associated cancer(s) will have the possibility to participate to a sub-analysis of this study, where their circulating plasma levels of biomarkers will be evaluated prior to resection (treatment-naive) and post-resection (to measure the molecular persistence of the disease after the resection) Receives: Diagnostic Test: BEACON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Specificity
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
Measured: Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Jan 2024
- Primary completion15 Jan 2031 (estimated)
- Study completion15 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Raffaele University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulia Martina Cavestro, MD, PhD, Principal investigator, IRCCS San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450612
- Sponsor's protocol ID
- BEACON/2026
- Acronym
- BEACON
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
Publications
Ahlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ, Knigge K, Lance MP, Burgart LJ, Hamilton SR, Allison JE, Lawson MJ, Devens ME, Harrington JJ, Hillman SL. Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med. 2008 Oct 7;149(7):441-50, W81. doi: 10.7326/0003-4819-149-7-200810070-00004.
PubMed 18838724Aziz Z, Wagner S, Agyekum A, Pumpalova YS, Prest M, Lim F, Rustgi S, Kastrinos F, Grady WM, Hur C. Cost-Effectiveness of Liquid Biopsy for Colorectal Cancer Screening in Patients Who Are Unscreened. JAMA Netw Open. 2023 Nov 1;6(11):e2343392. doi: 10.1001/jamanetworkopen.2023.43392.
PubMed 37971743Barnell EK, Kang Y, Wurtzler EM, Griffith M, Chaudhuri AA, Griffith OL; Geneoscopy Scientists. Noninvasive Detection of High-Risk Adenomas Using Stool-Derived Eukaryotic RNA Sequences as Biomarkers. Gastroenterology. 2019 Sep;157(3):884-887.e3. doi: 10.1053/j.gastro.2019.05.058. Epub 2019 May 30. No abstract available.
PubMed 31154021Barnell EK, Wurtzler EM, La Rocca J, Fitzgerald T, Petrone J, Hao Y, Kang Y, Holmes FL, Lieberman DA. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023 Nov 14;330(18):1760-1768. doi: 10.1001/jama.2023.22231.
PubMed 37870871Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
PubMed 24553385Carethers JM. Stool-Based Screening Tests for Colorectal Cancer. JAMA. 2023 Mar 14;329(10):839-840. doi: 10.1001/jama.2023.0547.
PubMed 36800187Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714.
PubMed 38477985Imperiale TF, Porter K, Zella J, Gagrat ZD, Olson MC, Statz S, Garces J, Lavin PT, Aguilar H, Brinberg D, Berkelhammer C, Kisiel JB, Limburg PJ; BLUE-C Study Investigators. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):984-993. doi: 10.1056/NEJMoa2310336.
PubMed 38477986Mannucci A, Balaguer F, Yamada Y, Nagasaka T, Toiyama Y, Okugawa Y, Marti-Gallostra M, Jimenez-Toscano M, Vidal-Tocino R, Jimenez F, Perea J, Quintero E, Boland CR, Cavestro GM, Goel A; SECOC-ENCODER Collaborators. An Exosome-Based Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer: The ENCODER Multicenter Study. Gastroenterology. 2026 Feb;170(2):330-343. doi: 10.1053/j.gastro.2025.08.013. Epub 2025 Dec 9.
PubMed 41364052Mannucci A, Goel A. Circulating Tumor DNA-Based Blood Test for Colorectal Cancer Screening. JAMA. 2025 Nov 11;334(18):1680-1681. doi: 10.1001/jama.2025.14109. No abstract available.
PubMed 41060624Mannucci A, Hernandez G, Uetake H, Yamada Y, Balaguer F, Baba H, Chen T, Chen J, Boland CR, Cavestro GM, Quintero E, Goel A. Prediction of long-term recurrence-free and overall survival in early-onset colorectal cancer: the ENCORE multi-centre study. NPJ Precis Oncol. 2025 Jun 21;9(1):202. doi: 10.1038/s41698-025-00978-7.
PubMed 40544180Negro S, Perissinotto E, Mammi I, Crivellari G, Schiavi F, Cappello F, Spolverato G, Ferrari D, Rausa E, Vitellaro M, Fassan M, Cavestro GM, Mannucci A, Lonardi S, Bergamo F, Urso EDL. Emerging therapeutic strategies in Lynch syndrome-associated colorectal cancer and the role of MMR testing. Tumori. 2025 Jan 30:3008916241310706. doi: 10.1177/03008916241310706. Online ahead of print.
PubMed 39882759Xu C, Mannucci A, Esposito F, Oliveres H, Alonso-Orduna V, Yubero A, Fernandez-Martos C, Salud A, Gallego J, Martin-Richard M, Fernandez-Plana J, Guillot M, Aparicio J, Fakih M, Kopetz S, Feliu J, Maurel J, Goel A. An Exosome-Based Liquid Biopsy Predicts Depth of Response and Survival Outcomes to Cetuximab and Panitumumab in Metastatic Colorectal Cancer: The EXONERATE Study. Clin Cancer Res. 2025 Mar 17;31(6):1002-1015. doi: 10.1158/1078-0432.CCR-24-1934.
PubMed 39820673Mannucci A, Goel A. Stool and blood biomarkers for colorectal cancer management: an update on screening and disease monitoring. Mol Cancer. 2024 Nov 19;23(1):259. doi: 10.1186/s12943-024-02174-w.
PubMed 39558327Mannucci A, Goel A. Stool and Blood DNA Tests for Colorectal Cancer Screening. N Engl J Med. 2024 Jun 20;390(23):2224. doi: 10.1056/NEJMc2404924. No abstract available.
PubMed 38899710
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
- ClinicalTrials.gov ID
- NCT07450612
- Acronym / sponsor ID
- BEACON / BEACON/2026
- Conditions
- Colorectal Cancer, Adenoma Colon, Adenoma Colon Polyp, Colon Adenoma, Colo-rectal Cancer, Colon Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- San Raffaele UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Jan 2031 (estimated)
- Study completion
- 15 Aug 2031 (estimated)
- First posted
- 4 Mar 2026 (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.
This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.
Detailed description
Colorectal cancer (CRC) remains a significant public health burden as the third-most commonly diagnosed and second-deadliest malignancy. While CRC is potentially preventable through the removal of precursor lesions known as advanced adenomas (AAs), current screening modalities have limitations. The fecal immunochemical test (FIT) exhibits reduced sensitivity for early-stage CRC and AAs, primarily lowering mortality rather than incidence. Colonoscopy, while effective, is invasive, costly, and suffers from suboptimal adherence. Additionally, individuals with Lynch syndrome (LS), who carry a pathogenic germline variant in mismatch repair (MMR) genes, lack effective and reliable methods for early-stage detection of non-CRC tumors associated with the syndrome.
The rationale of this study, BEACON/2026, is to develop and validate two blood-based tests to address these clinical gaps. The first is a screening test sensitive to both CRC and AAs to complement existing screening options; the second is a multi-cancer early detection (MCED) test tailored to the LS spectrum. The central hypothesis is that a liquid biopsy approach combining cell-free microRNAs (cf-miRNAs, which are sensitive) and exosome-bound microRNAs (exo-miRNAs, which are specific) can effectively distinguish patients with AAs, CRC, and LS-associated cancers from controls.
This study follows the Early Detection Research Network (EDRN) recommendations for biomarker development, including biomarker discovery, prioritization, training, and independent validation (Phases I through III). The experimental design complies with PROBE recommendations for prospectively collected biospecimens that are blindly evaluated. The procedure involves the collection of peripheral blood to isolate RNA from plasma or serum for reverse transcription, quantitative polymerase chain reaction (RT-qPCR) analysis and machine-learning modeling . This non-invasive approach aims to provide a cost-effective, patient-friendly alternative to improve screening participation and disease monitoring
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Lynch syndrome, without Lynch-syndrome associated cancers | – | Diagnostic Test: BEACONIndividuals with Lynch syndrome, who are free of Lynch-syndrome associated cancers at the time of blood drawing |
| Lynch syndrome, with Lynch-syndrome associated cancers | – | Diagnostic Test: BEACONIndividuals with Lynch syndrome, who have one (or more) Lynch-syndrome associated cancer(s) at the time of blood drawing |
| Colorectal cancer | – | Diagnostic Test: BEACONIndividuals with sporadic biopsy-proven colorectal cancer, as identified during routine colonoscopy and diagnosed via pathological review |
| Advanced adenoma | – | Diagnostic Test: BEACONIndividuals with sporadic advanced adenomas, defined as (i) more than 3 colorectal polyps, (ii) presence of high-grade dysplasia in one or more polyp, or (iii) polyp(s) >10 mm |
| Colonoscopy-negative controls | – | Diagnostic Test: BEACONIndividuals whose colonoscopy was negative for colorectal cancer and for advanced colorectal adenomas |
| Pre-treatment samples | – | Diagnostic Test: BEACONIndividuals with (i) colorectal cancer, or (ii) advanced adenomas, or (iii) Lynch syndrome associated cancer(s) will have the possibility to participate to a sub-analysis of this study, where their circulating plasma levels of biomarkers will be evaluated prior to resection (treatment-naive) and post-resection (to measure the molecular persistence of the disease after the resection) |
| Post-treatment samples | – | Diagnostic Test: BEACONIndividuals with (i) colorectal cancer, or (ii) advanced adenomas, or (iii) Lynch syndrome associated cancer(s) will have the possibility to participate to a sub-analysis of this study, where their circulating plasma levels of biomarkers will be evaluated prior to resection (treatment-naive) and post-resection (to measure the molecular persistence of the disease after the resection) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Seven independent cohorts of individuals who belong to one of the following seven: * Lynch syndrome, without any Lynch-syndrome-associated cancer * Lynch syndrome, with one or more Lynch-syndrome-associated cancer(s) * Sporadic colorectal cancer * Sporadic advanced adenoma (at most) * Colonoscopy-negative controls * Treatment-naive blood samples * Post-treatment blood samples
Key inclusion criteria (3 listed)
- All individuals included in the study need to have had a colonoscopy at the time of blood sampling.
- Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
- Received standard pathological and endoscopic diagnosis and assessment for cohort assignment
Key exclusion criteria (2 listed)
- Lack of informed consent
- Inflammatory bowel disease
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 |
|---|---|---|
| BEACONA panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples | Diagnostic test | Advanced adenoma, Colonoscopy-negative controls, Colorectal cancer, Lynch syndrome, with Lynch-syndrome associated cancers, Lynch syndrome, without Lynch-syndrome associated cancers, Post-treatment samples, Pre-treatment samples |
Primary outcome
Sensitivity
Time frame: Through study completion, an average of 1 year
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
2 secondary outcomes
Specificity
Time frame: Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
Time frame: Through study completion, an average of 1 year
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 4 Mar 2026.
- Background: PubMed 18838724Ahlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ, Knigge K, Lance MP, Burgart LJ, Hamilton SR, Allison JE, Lawson MJ, Devens ME, Harrington JJ, Hillman SL. Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med. 2008 Oct 7;149(7):441-50, W81. doi: 10.7326/0003-4819-149-7-200810070-00004.
- Background: PubMed 37971743Aziz Z, Wagner S, Agyekum A, Pumpalova YS, Prest M, Lim F, Rustgi S, Kastrinos F, Grady WM, Hur C. Cost-Effectiveness of Liquid Biopsy for Colorectal Cancer Screening in Patients Who Are Unscreened. JAMA Netw Open. 2023 Nov 1;6(11):e2343392. doi: 10.1001/jamanetworkopen.2023.43392.
- Background: PubMed 31154021Barnell EK, Kang Y, Wurtzler EM, Griffith M, Chaudhuri AA, Griffith OL; Geneoscopy Scientists. Noninvasive Detection of High-Risk Adenomas Using Stool-Derived Eukaryotic RNA Sequences as Biomarkers. Gastroenterology. 2019 Sep;157(3):884-887.e3. doi: 10.1053/j.gastro.2019.05.058. Epub 2019 May 30. No abstract available.
- Background: PubMed 37870871Barnell EK, Wurtzler EM, La Rocca J, Fitzgerald T, Petrone J, Hao Y, Kang Y, Holmes FL, Lieberman DA. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023 Nov 14;330(18):1760-1768. doi: 10.1001/jama.2023.22231.
- Background: PubMed 24553385Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
- Background: PubMed 36800187Carethers JM. Stool-Based Screening Tests for Colorectal Cancer. JAMA. 2023 Mar 14;329(10):839-840. doi: 10.1001/jama.2023.0547.
- Background: PubMed 38477985Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714.
- Background: PubMed 38477986Imperiale TF, Porter K, Zella J, Gagrat ZD, Olson MC, Statz S, Garces J, Lavin PT, Aguilar H, Brinberg D, Berkelhammer C, Kisiel JB, Limburg PJ; BLUE-C Study Investigators. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):984-993. doi: 10.1056/NEJMoa2310336.
- Background: PubMed 41364052Mannucci A, Balaguer F, Yamada Y, Nagasaka T, Toiyama Y, Okugawa Y, Marti-Gallostra M, Jimenez-Toscano M, Vidal-Tocino R, Jimenez F, Perea J, Quintero E, Boland CR, Cavestro GM, Goel A; SECOC-ENCODER Collaborators. An Exosome-Based Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer: The ENCODER Multicenter Study. Gastroenterology. 2026 Feb;170(2):330-343. doi: 10.1053/j.gastro.2025.08.013. Epub 2025 Dec 9.
- Background: PubMed 41060624Mannucci A, Goel A. Circulating Tumor DNA-Based Blood Test for Colorectal Cancer Screening. JAMA. 2025 Nov 11;334(18):1680-1681. doi: 10.1001/jama.2025.14109. No abstract available.
- Background: PubMed 40544180Mannucci A, Hernandez G, Uetake H, Yamada Y, Balaguer F, Baba H, Chen T, Chen J, Boland CR, Cavestro GM, Quintero E, Goel A. Prediction of long-term recurrence-free and overall survival in early-onset colorectal cancer: the ENCORE multi-centre study. NPJ Precis Oncol. 2025 Jun 21;9(1):202. doi: 10.1038/s41698-025-00978-7.
- Background: PubMed 39882759Negro S, Perissinotto E, Mammi I, Crivellari G, Schiavi F, Cappello F, Spolverato G, Ferrari D, Rausa E, Vitellaro M, Fassan M, Cavestro GM, Mannucci A, Lonardi S, Bergamo F, Urso EDL. Emerging therapeutic strategies in Lynch syndrome-associated colorectal cancer and the role of MMR testing. Tumori. 2025 Jan 30:3008916241310706. doi: 10.1177/03008916241310706. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
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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.
Giulia Martina Cavestro, MD, PhD principal investigator
IRCCS San Raffaele Hospital
4 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 and Adenoma Colon, run by San Raffaele University at 4 sites in Italy.
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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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 Giulia Martina Cavestro, MD, PhD (0226437217, cavestro.giuliamartina@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Through study completion, an average of 1 year). 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 NCT07450612, which also lists 21 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 4 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.