Newly-diagnosed Crohn's DiseaseNCT06457035
Development and Validation of a Nomogram for Predicting Surgery in Newly-diagnosed Crohn's Disease: a Retrospective Cohort Study
An observational study of Newly-diagnosed Crohn's Disease, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
A majority of patients with Crohn's disease undergo surgery during the disease course. We aimed to develop an easily available nomogram to predict the risk of surgery at diagnosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newly-diagnosed Crohn's Disease
- What is being tested?
- immunosuppressant
- How many people
- 490 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients newly diagnosed with Crohn's disease
Who may be able to join
- The diagnosis of CD was finally confirmed according to diagnostic criteria, including clinical manifestations and ileocolonoscopic, histopathologic, and radiologic evidence
- Laboratory data of complete blood count and routine blood biochemical examination were available within one week before the diagnostic ileocolonoscopy
Who cannot join
- The time of diagnosis was unclear
- They underwent bowel resection within three months after diagnosis, which reflected an early complicated disease
- They suffered from severe infection around the laboratory test
About this study
A majority of patients with Crohn's disease undergo surgery during the disease course. We aimed to develop an easily available nomogram to predict the risk of surgery at diagnosis.
Read the detailed description
Crohn's disease (CD), a chronic inflammatory disorder involving all of the gastrointestinal tract, has a progressive and destructive course and is increasing in incidence worldwide.1 Although the most common disease behavior of patients with newly-diagnosed CD is inflammatory (B1 in the Montreal Classification2), a rapid and prominent progression in disease behaviour will be observed in approximate half of the patients within 10 years after diagnosis.3-5 Data from a population-based cohort show that nearly half of patients developed intestinal complications such as strictures and fistulae, in the 20 years following the diagnosis.3 In spite of the application of immunosuppressive maintenance therapies, more than half of the patients suffer from severe complications and required intestinal resection.6,7 In recent decades, with the advent of targeted biologic therapies such as tumor necrosis factor antagonists, gut-selective monoclonal anti-integrin antibody and inhibitors of IL-12 and IL-23 signaling, the medical management of CD has been revolutionized.8 Earlier and more aggressive application of biologics or novel small molecules and combination therapies have been demonstrated to induce a profound alteration of natural disease course and diminish the requirement for hospitalization and surgery among patients with newly-diagnosed CD.9,10 Nevertheless, one of the most difficult challenges in the so-called top-down treatment strategy is the identification of patients who are at high risk for disease progression and thus necessitate more intensive treatment pattern despite the therapy-related adverse events and heavy costs. From another perspective, failure to identify high-risk patients also delays the prescription of more effective therapies and accounts for an increase in the risk of disease progression.
Much effort has been made in the field of baseline risk stratification for newly-diagnosed CD. Many clinical characteristics have been found to independently correlate with prognosis, including age at diagnosis, disease location, disease behavior, smoking status, and history of medication.9,11,12 Meanwhile, several prognostic biomarkers have been discovered in pilot studies, encompassing immune-related molecules and specific gene expression levels.13,14 Nonetheless, inconvenience and high expense has impeded their full validation and clinical application. Accordingly, the therapy selection is still tailored to the individual patient newly diagnosed with CD based on the clinical risk factors and patient comorbidities8, which is far from precision treatment.
In this era of artificial intelligence, a lot of machine learning models have been developed for innovation in all fields of inflammatory bowel disease, such as diagnosis, monitoring, disease course prediction and management.15 Unfortunately, the majority of popular machine learning prediction models are essentially black boxes, rendering verdicts with a few accompanying justifications, which limits clinical reliability and hence obstructs clinical implementation.16 To balance effectiveness with convenience and interpretability, we aimed to construct a well-interpreted Cox statistical regression model together with a nomogram based on clinical characteristics and available serological indicators to predict the long-term prognosis of newly diagnosed CD.
- Conditions
- Newly-diagnosed Crohn's Disease
- Being tested
- immunosuppressant
- Keywords
- Crohn's disease, surgery, nomogram, prediction model
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunosuppressantDrug
Also called biologics
No intervention was performed in this retrospective cohort study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement of surgery
need for bowel resection at any time
Measured: Any time during the follow-up (up to Dec 31, 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2005
- Primary completion31 Dec 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Newly-diagnosed Crohn's DiseaseStudies 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
- Retrospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Li, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457035
- Sponsor's protocol ID
- NOMOGRAM for Nd-CD
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roda G, Chien Ng S, Kotze PG, Argollo M, Panaccione R, Spinelli A, Kaser A, Peyrin-Biroulet L, Danese S. Crohn's disease. Nat Rev Dis Primers. 2020 Apr 2;6(1):22. doi: 10.1038/s41572-020-0156-2.
PubMed 32242028Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.
PubMed 16698746Thia KT, Sandborn WJ, Harmsen WS, Zinsmeister AR, Loftus EV Jr. Risk factors associated with progression to intestinal complications of Crohn's disease in a population-based cohort. Gastroenterology. 2010 Oct;139(4):1147-55. doi: 10.1053/j.gastro.2010.06.070. Epub 2010 Jul 14.
PubMed 20637205Tarrant KM, Barclay ML, Frampton CM, Gearry RB. Perianal disease predicts changes in Crohn's disease phenotype-results of a population-based study of inflammatory bowel disease phenotype. Am J Gastroenterol. 2008 Dec;103(12):3082-93. doi: 10.1111/j.1572-0241.2008.02212.x.
PubMed 19086959Louis E, Collard A, Oger AF, Degroote E, Aboul Nasr El Yafi FA, Belaiche J. Behaviour of Crohn's disease according to the Vienna classification: changing pattern over the course of the disease. Gut. 2001 Dec;49(6):777-82. doi: 10.1136/gut.49.6.777.
PubMed 11709511Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289-97. doi: 10.1038/ajg.2009.579. Epub 2009 Oct 27.
PubMed 19861953Bemelman WA, Warusavitarne J, Sampietro GM, Serclova Z, Zmora O, Luglio G, de Buck van Overstraeten A, Burke JP, Buskens CJ, Colombo F, Dias JA, Eliakim R, Elosua T, Gecim IE, Kolacek S, Kierkus J, Kolho KL, Lefevre JH, Millan M, Panis Y, Pinkney T, Russell RK, Shwaartz C, Vaizey C, Yassin N, D'Hoore A. ECCO-ESCP Consensus on Surgery for Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):1-16. doi: 10.1093/ecco-jcc/jjx061. No abstract available.
PubMed 28498901Cushing K, Higgins PDR. Management of Crohn Disease: A Review. JAMA. 2021 Jan 5;325(1):69-80. doi: 10.1001/jama.2020.18936.
PubMed 33399844Peyrin-Biroulet L, Oussalah A, Williet N, Pillot C, Bresler L, Bigard MA. Impact of azathioprine and tumour necrosis factor antagonists on the need for surgery in newly diagnosed Crohn's disease. Gut. 2011 Jul;60(7):930-6. doi: 10.1136/gut.2010.227884. Epub 2011 Jan 12.
PubMed 21228429Jenkinson PW, Plevris N, Siakavellas S, Lyons M, Arnott ID, Wilson D, Watson AJM, Jones GR, Lees CW. Temporal Trends in Surgical Resection Rates and Biologic Prescribing in Crohn's Disease: A Population-based Cohort Study. J Crohns Colitis. 2020 Sep 16;14(9):1241-1247. doi: 10.1093/ecco-jcc/jjaa044.
PubMed 32840295Ramadas AV, Gunesh S, Thomas GA, Williams GT, Hawthorne AB. Natural history of Crohn's disease in a population-based cohort from Cardiff (1986-2003): a study of changes in medical treatment and surgical resection rates. Gut. 2010 Sep;59(9):1200-6. doi: 10.1136/gut.2009.202101. Epub 2010 Jul 21.
PubMed 20650924Kugathasan S, Denson LA, Walters TD, Kim MO, Marigorta UM, Schirmer M, Mondal K, Liu C, Griffiths A, Noe JD, Crandall WV, Snapper S, Rabizadeh S, Rosh JR, Shapiro JM, Guthery S, Mack DR, Kellermayer R, Kappelman MD, Steiner S, Moulton DE, Keljo D, Cohen S, Oliva-Hemker M, Heyman MB, Otley AR, Baker SS, Evans JS, Kirschner BS, Patel AS, Ziring D, Trapnell BC, Sylvester FA, Stephens MC, Baldassano RN, Markowitz JF, Cho J, Xavier RJ, Huttenhower C, Aronow BJ, Gibson G, Hyams JS, Dubinsky MC. Prediction of complicated disease course for children newly diagnosed with Crohn's disease: a multicentre inception cohort study. Lancet. 2017 Apr 29;389(10080):1710-1718. doi: 10.1016/S0140-6736(17)30317-3. Epub 2017 Mar 2.
PubMed 28259484Forcione DG, Rosen MJ, Kisiel JB, Sands BE. Anti-Saccharomyces cerevisiae antibody (ASCA) positivity is associated with increased risk for early surgery in Crohn's disease. Gut. 2004 Aug;53(8):1117-22. doi: 10.1136/gut.2003.030734.
PubMed 15247177Smids C, Horjus Talabur Horje CS, Nierkens S, Drylewicz J, Groenen MJM, Wahab PJ, van Lochem EG. Candidate Serum Markers in Early Crohn's Disease: Predictors of Disease Course. J Crohns Colitis. 2017 Sep 1;11(9):1090-1100. doi: 10.1093/ecco-jcc/jjx049.
PubMed 28369318Stidham RW, Takenaka K. Artificial Intelligence for Disease Assessment in Inflammatory Bowel Disease: How Will it Change Our Practice? Gastroenterology. 2022 Apr;162(5):1493-1506. doi: 10.1053/j.gastro.2021.12.238. Epub 2022 Jan 4.
PubMed 34995537
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Nomogram for Predicting Surgery in Newly-diagnosed Crohn's Disease: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06457035
- Acronym / sponsor ID
- NOMOGRAM for Nd-CD
- Conditions
- Newly-diagnosed Crohn's Disease
- Keywords
- Crohn's disease, surgery, nomogram, prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 13 Jun 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.
A majority of patients with Crohn's disease undergo surgery during the disease course. We aimed to develop an easily available nomogram to predict the risk of surgery at diagnosis.
Detailed description
Crohn's disease (CD), a chronic inflammatory disorder involving all of the gastrointestinal tract, has a progressive and destructive course and is increasing in incidence worldwide.1 Although the most common disease behavior of patients with newly-diagnosed CD is inflammatory (B1 in the Montreal Classification2), a rapid and prominent progression in disease behaviour will be observed in approximate half of the patients within 10 years after diagnosis.3-5 Data from a population-based cohort show that nearly half of patients developed intestinal complications such as strictures and fistulae, in the 20 years following the diagnosis.3 In spite of the application of immunosuppressive maintenance therapies, more than half of the patients suffer from severe complications and required intestinal resection.6,7 In recent decades, with the advent of targeted biologic therapies such as tumor necrosis factor antagonists, gut-selective monoclonal anti-integrin antibody and inhibitors of IL-12 and IL-23 signaling, the medical management of CD has been revolutionized.8 Earlier and more aggressive application of biologics or novel small molecules and combination therapies have been demonstrated to induce a profound alteration of natural disease course and diminish the requirement for hospitalization and surgery among patients with newly-diagnosed CD.9,10 Nevertheless, one of the most difficult challenges in the so-called top-down treatment strategy is the identification of patients who are at high risk for disease progression and thus necessitate more intensive treatment pattern despite the therapy-related adverse events and heavy costs. From another perspective, failure to identify high-risk patients also delays the prescription of more effective therapies and accounts for an increase in the risk of disease progression.
Much effort has been made in the field of baseline risk stratification for newly-diagnosed CD. Many clinical characteristics have been found to independently correlate with prognosis, including age at diagnosis, disease location, disease behavior, smoking status, and history of medication.9,11,12 Meanwhile, several prognostic biomarkers have been discovered in pilot studies, encompassing immune-related molecules and specific gene expression levels.13,14 Nonetheless, inconvenience and high expense has impeded their full validation and clinical application. Accordingly, the therapy selection is still tailored to the individual patient newly diagnosed with CD based on the clinical risk factors and patient comorbidities8, which is far from precision treatment.
In this era of artificial intelligence, a lot of machine learning models have been developed for innovation in all fields of inflammatory bowel disease, such as diagnosis, monitoring, disease course prediction and management.15 Unfortunately, the majority of popular machine learning prediction models are essentially black boxes, rendering verdicts with a few accompanying justifications, which limits clinical reliability and hence obstructs clinical implementation.16 To balance effectiveness with convenience and interpretability, we aimed to construct a well-interpreted Cox statistical regression model together with a nomogram based on clinical characteristics and available serological indicators to predict the long-term prognosis of newly diagnosed CD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients newly diagnosed with Crohn's disease
Key inclusion criteria (2 listed)
- The diagnosis of CD was finally confirmed according to diagnostic criteria, including clinical manifestations and ileocolonoscopic, histopathologic, and radiologic evidence
- Laboratory data of complete blood count and routine blood biochemical examination were available within one week before the diagnostic ileocolonoscopy
Key exclusion criteria (3 listed)
- The time of diagnosis was unclear
- They underwent bowel resection within three months after diagnosis, which reflected an early complicated disease
- They suffered from severe infection around the laboratory test
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 |
|---|---|---|
| immunosuppressantAlso: biologicsNo intervention was performed in this retrospective cohort study. | Drug | – |
Primary outcome
Requirement of surgery
Time frame: Any time during the follow-up (up to Dec 31, 2022)
need for bowel resection at any time
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 13 Jun 2024.
- Background: PubMed 32242028Roda G, Chien Ng S, Kotze PG, Argollo M, Panaccione R, Spinelli A, Kaser A, Peyrin-Biroulet L, Danese S. Crohn's disease. Nat Rev Dis Primers. 2020 Apr 2;6(1):22. doi: 10.1038/s41572-020-0156-2.
- Background: PubMed 16698746Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.
- Background: PubMed 20637205Thia KT, Sandborn WJ, Harmsen WS, Zinsmeister AR, Loftus EV Jr. Risk factors associated with progression to intestinal complications of Crohn's disease in a population-based cohort. Gastroenterology. 2010 Oct;139(4):1147-55. doi: 10.1053/j.gastro.2010.06.070. Epub 2010 Jul 14.
- Background: PubMed 19086959Tarrant KM, Barclay ML, Frampton CM, Gearry RB. Perianal disease predicts changes in Crohn's disease phenotype-results of a population-based study of inflammatory bowel disease phenotype. Am J Gastroenterol. 2008 Dec;103(12):3082-93. doi: 10.1111/j.1572-0241.2008.02212.x.
- Background: PubMed 11709511Louis E, Collard A, Oger AF, Degroote E, Aboul Nasr El Yafi FA, Belaiche J. Behaviour of Crohn's disease according to the Vienna classification: changing pattern over the course of the disease. Gut. 2001 Dec;49(6):777-82. doi: 10.1136/gut.49.6.777.
- Background: PubMed 19861953Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289-97. doi: 10.1038/ajg.2009.579. Epub 2009 Oct 27.
- Background: PubMed 28498901Bemelman WA, Warusavitarne J, Sampietro GM, Serclova Z, Zmora O, Luglio G, de Buck van Overstraeten A, Burke JP, Buskens CJ, Colombo F, Dias JA, Eliakim R, Elosua T, Gecim IE, Kolacek S, Kierkus J, Kolho KL, Lefevre JH, Millan M, Panis Y, Pinkney T, Russell RK, Shwaartz C, Vaizey C, Yassin N, D'Hoore A. ECCO-ESCP Consensus on Surgery for Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):1-16. doi: 10.1093/ecco-jcc/jjx061. No abstract available.
- Background: PubMed 33399844Cushing K, Higgins PDR. Management of Crohn Disease: A Review. JAMA. 2021 Jan 5;325(1):69-80. doi: 10.1001/jama.2020.18936.
- Background: PubMed 21228429Peyrin-Biroulet L, Oussalah A, Williet N, Pillot C, Bresler L, Bigard MA. Impact of azathioprine and tumour necrosis factor antagonists on the need for surgery in newly diagnosed Crohn's disease. Gut. 2011 Jul;60(7):930-6. doi: 10.1136/gut.2010.227884. Epub 2011 Jan 12.
- Background: PubMed 32840295Jenkinson PW, Plevris N, Siakavellas S, Lyons M, Arnott ID, Wilson D, Watson AJM, Jones GR, Lees CW. Temporal Trends in Surgical Resection Rates and Biologic Prescribing in Crohn's Disease: A Population-based Cohort Study. J Crohns Colitis. 2020 Sep 16;14(9):1241-1247. doi: 10.1093/ecco-jcc/jjaa044.
- Background: PubMed 20650924Ramadas AV, Gunesh S, Thomas GA, Williams GT, Hawthorne AB. Natural history of Crohn's disease in a population-based cohort from Cardiff (1986-2003): a study of changes in medical treatment and surgical resection rates. Gut. 2010 Sep;59(9):1200-6. doi: 10.1136/gut.2009.202101. Epub 2010 Jul 21.
- Background: PubMed 28259484Kugathasan S, Denson LA, Walters TD, Kim MO, Marigorta UM, Schirmer M, Mondal K, Liu C, Griffiths A, Noe JD, Crandall WV, Snapper S, Rabizadeh S, Rosh JR, Shapiro JM, Guthery S, Mack DR, Kellermayer R, Kappelman MD, Steiner S, Moulton DE, Keljo D, Cohen S, Oliva-Hemker M, Heyman MB, Otley AR, Baker SS, Evans JS, Kirschner BS, Patel AS, Ziring D, Trapnell BC, Sylvester FA, Stephens MC, Baldassano RN, Markowitz JF, Cho J, Xavier RJ, Huttenhower C, Aronow BJ, Gibson G, Hyams JS, Dubinsky MC. Prediction of complicated disease course for children newly diagnosed with Crohn's disease: a multicentre inception cohort study. Lancet. 2017 Apr 29;389(10080):1710-1718. doi: 10.1016/S0140-6736(17)30317-3. Epub 2017 Mar 2.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly-diagnosed Crohn's Disease, run by First Affiliated Hospital, Sun Yat-Sen University.
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 2 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: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Requirement of surgery (time frame: Any time during the follow-up (up to Dec 31, 2022)). 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 NCT06457035, which also lists 16 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 13 Jun 2024.