Duodenum CancerDRACONCT07199127
Duodenal Polyposis Classification in FAP
An observational study of Duodenum Cancer and Familial Adenomatous Polyposis, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
Trial summary
Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy for advanced neoplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenum Cancer, Familial Adenomatous Polyposis, Duodenal Polyposis
- What is being tested?
- DRACO
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 2 Feb 2018to 15 Jan 2030
- 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: Individuals with familial adenomatous polyposis, defined by a pathogenic/likely pathogenic germline Adenonomatous Polyposis Coli (APC) gene variant, undergoing surveillance for duodenal polyposis using esophagogastroduondeoscopy (EGD)
Who may be able to join
- Confirmed germline diagnosis of FAP, as defined by genetic testing
- Two or more upper gastrointestinal endoscopies
- Complete documentation of all Spigelman classification variables at each endoscopic evaluation
Who cannot join
- Histological grading of duodenal polyps incomplete
- Follow-up data were unavailable
- Duodenal surgery before study baseline endoscopy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20129
Giulia Martina Cavestro, M.D., Ph.D., cavestro.giuliamartina@hsr.it
Giulia Martina Cavestro, M.D., Ph.D.
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Marco Vitellaro, M.D.
Marco Vitellaro, M.D.
About this study
Official title: Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis
Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy for advanced neoplasia. The DRACO study (Duodenal Risk Assessment in adenomatous polyposis Coli -Oncogene) is a multicenter, STROBE- and CONSORT-compliant cohort study that analyzes upper endoscopies from genetically confirmed FAP patients across independent cohorts to develop, validate, and externally test two multivariable risk models.
Read the detailed description
Duodenal cancers represent the leading cause of cancer-related mortality in individuals with familial adenomatous polyposis (FAP). While endoscopic surveillance is a critical component of duodenal cancer management, clinical decisions are primarily guided by the Spigelman staging system. Introduced in 1989, this framework stratifies patients into four stages based on duodenal polyp size, number, histology, and the grade of dysplasia.
Despite its widespread use, the Spigelman system was not originally designed to predict cancer incidence or progression and lacks formal validation for these outcomes. A recent systematic review and meta-analysis confirmed its limited sensitivity for detecting duodenal cancers, at approximately 50%, with even lower sensitivity for papillary cancer. This limitation in early cancer detection also constrains the identification of patients at elevated risk of malignant transformation during a window in which endoscopic intervention might still be feasible. As high-grade dysplasia (HGD) is a well-established precursor to adenocarcinoma and a valid therapeutic target, the inability of the current system to anticipate HGD and its progression to cancer can undermine opportunities for timely, minimally invasive intervention.
The current clinical paradigm reserves prophylactic surgery or intensified endoscopic therapy primarily for patients with Spigelman stage IV disease. However, both cancer and high-grade dysplasia frequently arise in patients with lower-stage disease. Given the already limited sensitivity of the Spigelman system for cancer detection, its sensitivity for predicting the development of HGD is likely even lower. Consequently, relying on a stage IV threshold may delay preventive intervention beyond the window of opportunity for feasible endoscopic management.
These limitations have led to a growing recognition of the need to revise the Spigelman classification system. Two broad strategies have been proposed to improve its clinical utility: reweighting the existing components to better reflect their prognostic contribution, or integrating patient-level variables, such as age and desmoid tumor status, to more accurately capture individual risk trajectories. Importantly, a staging system intended to guide endoscopic surveillance should prioritize prevention by informing timely intervention before malignant transformation occurs. Therefore, risk stratification must be grounded in the likelihood of developing pre-cancerous lesions, such as high-grade dysplasia, not solely on the risk of overt carcinoma. The DRACO study was designed to fill this gap in knowledge.
- Conditions
- Duodenum Cancer, Familial Adenomatous Polyposis, Duodenal Polyposis, Ampulla of Vater Adenoma, FAP Gene Mutation, FAP
- Being tested
- DRACO
- Keywords
- Spigelman, Duodenal Polyposis
- Medical subject headings
- Duodenal Neoplasms, Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRACODiagnostic test
Also called Duodenal Risk Assessment in adenomatous polyposis Coli Oncogene
A novel endoscopic classification to predict the risk of duodenal and ampullary high-grade dysplasia and cancer from baseline esophagogastroduodenoscopy (EGD)
| Study group | Role | What they receive |
|---|---|---|
| Individuals with duodenal advanced neoplasia (Training cohort) | Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the training cohort (aka, cases) Receives: Diagnostic Test: DRACO | |
| Individuals with duodenal advanced neoplasia (validation cohort) | Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the validation cohort (aka, cases) Receives: Diagnostic Test: DRACO | |
| Individuals with duodenal advanced neoplasia (Testing cohort) | Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the testing cohort (aka, cases) Receives: Diagnostic Test: DRACO | |
| Individuals without duodenal advanced neoplasia (Training cohort) | Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the training cohort (aka, controls) Receives: Diagnostic Test: DRACO | |
| Individuals without duodenal advanced neoplasia (Validation cohort) | Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the validation cohort (aka, controls) Receives: Diagnostic Test: DRACO | |
| Individuals without duodenal advanced neoplasia (Testing cohort) | Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the testing cohort (aka, controls) Receives: Diagnostic Test: DRACO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
True Positivity Rate: the probability of a positive test result, conditioned on the individual truly developing duodenal or ampullary high-grade dysplasia or adenocarcinoma
Measured: Through study completion, on average 5 years
Secondary outcomes (2)
Specificity
True Negative Rate: the probability of a negative test result, conditioned on the individual being truly free from duodenal or ampullary high-grade dysplasia or adenocarcinoma
Measured: Through study completion, on average 5 years
Proportion of correct predictions (true positives and true negatives) among the total 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, on average 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start2 Feb 2018
- Primary completion25 Aug 2025
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Duodenum 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Ospedale San Raffaele
- Responsible party
- Sponsor
- Investigators
- Marco Vitellaro, M.D., Study chair, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199127
- Sponsor's protocol ID
- IRB# INT-12/18
- Acronym
- DRACO
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- 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' upon approval of the proposed use of such data
Publications
Bulow S, Christensen IJ, Hojen H, Bjork J, Elmberg M, Jarvinen H, Lepisto A, Nieuwenhuis M, Vasen H. Duodenal surveillance improves the prognosis after duodenal cancer in familial adenomatous polyposis. Colorectal Dis. 2012 Aug;14(8):947-52. doi: 10.1111/j.1463-1318.2011.02844.x.
PubMed 21973191Zaffaroni G, Mannucci A, Koskenvuo L, de Lacy B, Maffioli A, Bisseling T, Half E, Cavestro GM, Valle L, Ryan N, Aretz S, Brown K, Buttitta F, Carneiro F, Claber O, Blanco-Colino R, Collard M, Crosbie E, Cunha M, Doulias T, Fleming C, Heinrich H, Huneburg R, Metras J, Nagtegaal I, Negoi I, Nielsen M, Pellino G, Ricciardiello L, Sagir A, Sanchez-Guillen L, Seppala TT, Siersema P, Striebeck B, Sampson JR, Latchford A, Parc Y, Burn J, Moslein G. Updated European guidelines for clinical management of familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), gastric adenocarcinoma, proximal polyposis of the stomach (GAPPS) and other rare adenomatous polyposis syndromes: a joint EHTG-ESCP revision. Br J Surg. 2024 May 3;111(5):znae070. doi: 10.1093/bjs/znae070.
PubMed 38722804Mannucci A, Puzzono M, Goel A, Moslein G, Balafas S, Di Serio MS, Cavestro GM. The Spigelman Staging System and the Risk of Duodenal and Papillary Cancer in Familial Adenomatous Polyposis: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2024 Apr 1;119(4):617-624. doi: 10.14309/ajg.0000000000002688. Epub 2024 Jan 31.
PubMed 38294150Karstensen JG, Bulow S, Hojen H, Jelsig AM, Jespersen N, Andersen KK, Wewer MD, Burisch J, Pommergaard HC. Cancer in Patients With Familial Adenomatous Polyposis: A Nationwide Danish Cohort Study With Matched Controls. Gastroenterology. 2023 Sep;165(3):573-581.e3. doi: 10.1053/j.gastro.2023.05.010. Epub 2023 May 16.
PubMed 37201686
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT07199127
- Acronym / sponsor ID
- DRACO / IRB# INT-12/18
- Conditions
- Duodenum Cancer, Familial Adenomatous Polyposis, Duodenal Polyposis, Ampulla of Vater Adenoma, FAP Gene Mutation, FAP
- Keywords
- Spigelman, Duodenal Polyposis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- IRCCS Ospedale San Raffaele
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 30 Sep 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.
Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy for advanced neoplasia. The DRACO study (Duodenal Risk Assessment in adenomatous polyposis Coli -Oncogene) is a multicenter, STROBE- and CONSORT-compliant cohort study that analyzes upper endoscopies from genetically confirmed FAP patients across independent cohorts to develop, validate, and externally test two multivariable risk models.
Detailed description
Duodenal cancers represent the leading cause of cancer-related mortality in individuals with familial adenomatous polyposis (FAP). While endoscopic surveillance is a critical component of duodenal cancer management, clinical decisions are primarily guided by the Spigelman staging system. Introduced in 1989, this framework stratifies patients into four stages based on duodenal polyp size, number, histology, and the grade of dysplasia.
Despite its widespread use, the Spigelman system was not originally designed to predict cancer incidence or progression and lacks formal validation for these outcomes. A recent systematic review and meta-analysis confirmed its limited sensitivity for detecting duodenal cancers, at approximately 50%, with even lower sensitivity for papillary cancer. This limitation in early cancer detection also constrains the identification of patients at elevated risk of malignant transformation during a window in which endoscopic intervention might still be feasible. As high-grade dysplasia (HGD) is a well-established precursor to adenocarcinoma and a valid therapeutic target, the inability of the current system to anticipate HGD and its progression to cancer can undermine opportunities for timely, minimally invasive intervention.
The current clinical paradigm reserves prophylactic surgery or intensified endoscopic therapy primarily for patients with Spigelman stage IV disease. However, both cancer and high-grade dysplasia frequently arise in patients with lower-stage disease. Given the already limited sensitivity of the Spigelman system for cancer detection, its sensitivity for predicting the development of HGD is likely even lower. Consequently, relying on a stage IV threshold may delay preventive intervention beyond the window of opportunity for feasible endoscopic management.
These limitations have led to a growing recognition of the need to revise the Spigelman classification system. Two broad strategies have been proposed to improve its clinical utility: reweighting the existing components to better reflect their prognostic contribution, or integrating patient-level variables, such as age and desmoid tumor status, to more accurately capture individual risk trajectories. Importantly, a staging system intended to guide endoscopic surveillance should prioritize prevention by informing timely intervention before malignant transformation occurs. Therefore, risk stratification must be grounded in the likelihood of developing pre-cancerous lesions, such as high-grade dysplasia, not solely on the risk of overt carcinoma. The DRACO study was designed to fill this gap in knowledge.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Individuals with duodenal advanced neoplasia (Training cohort) | – | Diagnostic Test: DRACOIndividuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the training cohort (aka, cases) |
| Individuals with duodenal advanced neoplasia (validation cohort) | – | Diagnostic Test: DRACOIndividuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the validation cohort (aka, cases) |
| Individuals with duodenal advanced neoplasia (Testing cohort) | – | Diagnostic Test: DRACOIndividuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the testing cohort (aka, cases) |
| Individuals without duodenal advanced neoplasia (Training cohort) | – | Diagnostic Test: DRACOIndividuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the training cohort (aka, controls) |
| Individuals without duodenal advanced neoplasia (Validation cohort) | – | Diagnostic Test: DRACOIndividuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the validation cohort (aka, controls) |
| Individuals without duodenal advanced neoplasia (Testing cohort) | – | Diagnostic Test: DRACOIndividuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the testing cohort (aka, controls) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with familial adenomatous polyposis, defined by a pathogenic/likely pathogenic germline Adenonomatous Polyposis Coli (APC) gene variant, undergoing surveillance for duodenal polyposis using esophagogastroduondeoscopy (EGD)
Key inclusion criteria (3 listed)
- Confirmed germline diagnosis of FAP, as defined by genetic testing
- Two or more upper gastrointestinal endoscopies
- Complete documentation of all Spigelman classification variables at each endoscopic evaluation
Key exclusion criteria (3 listed)
- Histological grading of duodenal polyps incomplete
- Follow-up data were unavailable
- Duodenal surgery before study baseline endoscopy
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 |
|---|---|---|
| DRACOAlso: Duodenal Risk Assessment in adenomatous polyposis Coli OncogeneA novel endoscopic classification to predict the risk of duodenal and ampullary high-grade dysplasia and cancer from baseline esophagogastroduodenoscopy (EGD) | Diagnostic test | Individuals with duodenal advanced neoplasia (Testing cohort), Individuals with duodenal advanced neoplasia (Training cohort), Individuals with duodenal advanced neoplasia (validation cohort), Individuals without duodenal advanced neoplasia (Testing cohort), Individuals without duodenal advanced neoplasia (Training cohort), Individuals without duodenal advanced neoplasia (Validation cohort) |
Primary outcome
Sensitivity
Time frame: Through study completion, on average 5 years
True Positivity Rate: the probability of a positive test result, conditioned on the individual truly developing duodenal or ampullary high-grade dysplasia or adenocarcinoma
2 secondary outcomes
Specificity
Time frame: Through study completion, on average 5 years
Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)
Time frame: Through study completion, on average 5 years
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 30 Sep 2025.
- Background: PubMed 21973191Bulow S, Christensen IJ, Hojen H, Bjork J, Elmberg M, Jarvinen H, Lepisto A, Nieuwenhuis M, Vasen H. Duodenal surveillance improves the prognosis after duodenal cancer in familial adenomatous polyposis. Colorectal Dis. 2012 Aug;14(8):947-52. doi: 10.1111/j.1463-1318.2011.02844.x.
- Background: PubMed 38722804Zaffaroni G, Mannucci A, Koskenvuo L, de Lacy B, Maffioli A, Bisseling T, Half E, Cavestro GM, Valle L, Ryan N, Aretz S, Brown K, Buttitta F, Carneiro F, Claber O, Blanco-Colino R, Collard M, Crosbie E, Cunha M, Doulias T, Fleming C, Heinrich H, Huneburg R, Metras J, Nagtegaal I, Negoi I, Nielsen M, Pellino G, Ricciardiello L, Sagir A, Sanchez-Guillen L, Seppala TT, Siersema P, Striebeck B, Sampson JR, Latchford A, Parc Y, Burn J, Moslein G. Updated European guidelines for clinical management of familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), gastric adenocarcinoma, proximal polyposis of the stomach (GAPPS) and other rare adenomatous polyposis syndromes: a joint EHTG-ESCP revision. Br J Surg. 2024 May 3;111(5):znae070. doi: 10.1093/bjs/znae070.
- Background: PubMed 38294150Mannucci A, Puzzono M, Goel A, Moslein G, Balafas S, Di Serio MS, Cavestro GM. The Spigelman Staging System and the Risk of Duodenal and Papillary Cancer in Familial Adenomatous Polyposis: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2024 Apr 1;119(4):617-624. doi: 10.14309/ajg.0000000000002688. Epub 2024 Jan 31.
- Results publication: PubMed 37201686Karstensen JG, Bulow S, Hojen H, Jelsig AM, Jespersen N, Andersen KK, Wewer MD, Burisch J, Pommergaard HC. Cancer in Patients With Familial Adenomatous Polyposis: A Nationwide Danish Cohort Study With Matched Controls. Gastroenterology. 2023 Sep;165(3):573-581.e3. doi: 10.1053/j.gastro.2023.05.010. Epub 2023 May 16.
- 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' upon 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.
Marco Vitellaro, M.D. study chair
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duodenum Cancer and Familial Adenomatous Polyposis, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 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 3 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 30 Sep 2025. 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 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 Marco Vitellaro, M.D. (+393480197920, marco.vitellaro@istitutotumori.mi.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, on average 5 years). 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 NCT07199127, which also lists 4 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 30 Sep 2025.