Crohn DiseaseNCT04654494
Colorectal Cancer in Crohn's Disease
An observational study of Crohn Disease and Colorectal Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset. Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Colorectal Cancer, Inflammatory Bowel Diseases
- What is being tested?
- Total proctocolectomy, Total colectomy and Segmental colectomy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2020to Jan 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: Patients with Crohn's disease complicated by occurrence of colorectal cancer, treated surgically between 01/2010 and 01/2020
Who may be able to join
- All patients with a diagnosis of Crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020
Who cannot join
- Patients who underwent non-oncologic segmental resection will be excluded from outcome analysis.
- Patients with known genetic colorectal cancer syndromes (eg. Familial Adenomatous Polyposis, Hereditary Non-Polyposis ColoRectal Cancer Syndrome)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Tor Vergata
Roma, RM, 00133
Bruno Sensi, MD, 3385352902, brunosensi@outlook.it
Giuseppe S Sica, MD, PhD, 3385333659, sigisica@gmail.com
About this study
Official title: Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures
Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset.
Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible.
The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR).
Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).
- Being tested
- Total proctocolectomy, Total colectomy, Segmental colectomy
- Keywords
- colorectal surgery
- Medical subject headings
- Crohn Disease, Colorectal Neoplasms, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total proctocolectomyProcedure or surgery
excision of the whole large bowel including colon and rectum and end ileostomy fashioning
Total colectomyProcedure or surgery
excision of the colon with preservation of the rectum
Segmental colectomyProcedure or surgery
excision of a segment of colon
| Study group | Role | What they receive |
|---|---|---|
| Chron's disease patients with colorectal cancer | This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically Receives: Procedure: Total proctocolectomy; Procedure: Total colectomy; Procedure: Segmental colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
percentage of patients alive
Measured: 5 years
disease free survival
percentage of patients disease free
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jul 2020
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654494
- Sponsor's protocol ID
- REGISTROSPERIMENTAZIONI120/20
- Status last verified
- Dec 2020
- First submitted
- 29 Nov 2020
- Last updated
- 8 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 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures
- ClinicalTrials.gov ID
- NCT04654494
- Acronym / sponsor ID
- REGISTROSPERIMENTAZIONI120/20
- Keywords
- colorectal surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 4 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.
Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset.
Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible.
The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR).
Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chron's disease patients with colorectal cancer | – | Procedure: Total proctocolectomy, Procedure: Total colectomy, Procedure: Segmental colectomyThis group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Crohn's disease complicated by occurrence of colorectal cancer, treated surgically between 01/2010 and 01/2020
Key inclusion criteria (1 listed)
- All patients with a diagnosis of Crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020
Key exclusion criteria (2 listed)
- Patients who underwent non-oncologic segmental resection will be excluded from outcome analysis.
- Patients with known genetic colorectal cancer syndromes (eg. Familial Adenomatous Polyposis, Hereditary Non-Polyposis ColoRectal Cancer Syndrome)
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 proctocolectomyexcision of the whole large bowel including colon and rectum and end ileostomy fashioning | Procedure or surgery | Chron's disease patients with colorectal cancer |
| Total colectomyexcision of the colon with preservation of the rectum | Procedure or surgery | Chron's disease patients with colorectal cancer |
| Segmental colectomyexcision of a segment of colon | Procedure or surgery | Chron's disease patients with colorectal cancer |
Primary outcome
Overall Survival
Time frame: 5 years
percentage of patients alive
disease free survival
Time frame: 5 years
percentage of patients disease free
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Colorectal Cancer, run by University of Rome Tor Vergata at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 8 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Sensi, MD (3385352902, brunosensi@outlook.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 5 years). 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 8 Dec 2020.