Ulcerative ColitisUC-RectalKNCT04659148
Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer
An observational study of Ulcerative Colitis and Rectal Cancer, run by Istituto Clinico Humanitas at 2 sites in 2 countries.
Trial summary
This is a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Rectal Cancer
- What is being tested?
- Total proctocolectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2020to 1 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adult patients with a proven diagnosis of Ulcerative Colitis and rectal adenocarcinoma, who underwent intestinal resection for curative intent, in elective or emergent setting, in the period between January 2004 and January 2020.
Who may be able to join
- Patients diagnosed with Ulcerative Colitis;
- Patients diagnosed with rectal cancer (within 15 cm from the anal verge);
- Patients who underwent surgery for rectal cancer between January 2004 and January 2020;
- All type of surgery will be included;
- Surgery in elective and emergency settings.
Who cannot join
- Patients aged<18 years;
- Patients with a diagnosis of undetermined colitis;
- Insufficient follow-up data.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, MI, 20089
Humanitas R Hospital, 0282247776, annalisa.maroli@humanitas.it
antonino.spinelli@humanitas.it
United Kingdom1 site, 1 recruiting
- Recruiting
St. Mark's Hospital
Harrow, HA1 3UJ
Vittoria Bellato, MD, (0)20 8864 3232 ext. +44, vittoria.bellato@gmail.com
Janindra Warusavitarne, MD, PhD
About this study
Official title: Surgical and Oncological Outcomes in Patients With Ulcerative Colitis Associated Rectal Cancer: a Retrospective Study
This is a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer.
Read the detailed description
Inflammatory Bowel Disease (IBD) is a risk factor for the development of colorectal cancer (CRC). Despite improved targeted screening and timely prophylactic resection, up to 15% of all IBD-related mortality can be attributed to CRC.
Previous reports suggest that IBD patients present with CRC at an earlier age and with more advanced disease than those with sporadic CRC. The literature is limited, however, with respect to colitis-associated rectal cancer (CARC), which has unique considerations such as surgical approach and the use of neoadjuvant therapy. Although total proctocolectomy is generally the procedure of choice for those with CARC, recent reports reported acceptable oncological outcomes after ileal pouch-anal anastomosis (IPAA) and ileorectal anastomosis (IRA).
The impact of the type of surgical procedure on the oncologic outcome in patients with CARC is not well defined.
The aim of this study is to investigate short-term surgical outcomes (postoperative complications at 30 days after surgery) and long-term oncological outcomes (disease-free survival) of CARC patients undergoing different surgical approaches.
- Conditions
- Ulcerative Colitis, Rectal Cancer
- Being tested
- Total proctocolectomy
- Keywords
- Ulcerative Colitis, Rectal Cancer
- Medical subject headings
- Colitis, Ulcerative, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total proctocolectomyProcedure or surgery
Total proctocolectomy: surgical removal of the colon, rectum, and anus
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical outcome
30 days postoperative complications
Measured: 30 days after surgery
Oncological outcome
Disease-free survival
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Jan 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD, PhD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659148
- Sponsor's protocol ID
- 2712-2020
- Acronym
- UC-RectalK
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Oncological Outcomes in Patients With Ulcerative Colitis Associated Rectal Cancer: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04659148
- Acronym / sponsor ID
- UC-RectalK / 2712-2020
- Conditions
- Ulcerative Colitis, Rectal Cancer
- Keywords
- Ulcerative Colitis, Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 9 Dec 2020 (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 a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer.
Detailed description
Inflammatory Bowel Disease (IBD) is a risk factor for the development of colorectal cancer (CRC). Despite improved targeted screening and timely prophylactic resection, up to 15% of all IBD-related mortality can be attributed to CRC.
Previous reports suggest that IBD patients present with CRC at an earlier age and with more advanced disease than those with sporadic CRC. The literature is limited, however, with respect to colitis-associated rectal cancer (CARC), which has unique considerations such as surgical approach and the use of neoadjuvant therapy. Although total proctocolectomy is generally the procedure of choice for those with CARC, recent reports reported acceptable oncological outcomes after ileal pouch-anal anastomosis (IPAA) and ileorectal anastomosis (IRA).
The impact of the type of surgical procedure on the oncologic outcome in patients with CARC is not well defined.
The aim of this study is to investigate short-term surgical outcomes (postoperative complications at 30 days after surgery) and long-term oncological outcomes (disease-free survival) of CARC patients undergoing different surgical approaches.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients with a proven diagnosis of Ulcerative Colitis and rectal adenocarcinoma, who underwent intestinal resection for curative intent, in elective or emergent setting, in the period between January 2004 and January 2020.
Key inclusion criteria (5 listed)
- Patients diagnosed with Ulcerative Colitis;
- Patients diagnosed with rectal cancer (within 15 cm from the anal verge);
- Patients who underwent surgery for rectal cancer between January 2004 and January 2020;
- All type of surgery will be included;
- Surgery in elective and emergency settings.
Key exclusion criteria (3 listed)
- Patients aged<18 years;
- Patients with a diagnosis of undetermined colitis;
- Insufficient follow-up data.
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 |
|---|---|---|
| Total proctocolectomyTotal proctocolectomy: surgical removal of the colon, rectum, and anus | Procedure or surgery | – |
Primary outcome
Surgical outcome
Time frame: 30 days after surgery
30 days postoperative complications
Oncological outcome
Time frame: 5 years after surgery
Disease-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Antonino Spinelli, MD, PhD principal investigator
Istituto Clinico Humanitas
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Rectal Cancer, run by Istituto Clinico Humanitas at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 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: status not confirmed, as of the sponsor's last update on 9 Dec 2020. 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, United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Maroli (+390282247776, annalisa.maroli@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical outcome (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2020.