Colorectal Cancer in Crohn's Disease | NCT04654494

Studies
Colorectal Cancer in Crohn's Disease

NCT04654494

Sponsor

University of Rome Tor Vergata

Status

Unknown status

Last Update Posted

Dec 8, 2020Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Crohn Disease
Colorectal Cancer
Inflammatory Bowel Diseases

Interventions

Total proctocolectomy
Total colectomy
Segmental colectomy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jan 2021Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Nov 29, 2020

First Submission Date that Met QC Criteria

Nov 29, 2020

First Posted Date

Dec 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2020

Last Update Posted Date

Dec 8, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Sigismondo Sica, Associate Professor, Head of Department, University of Rome Tor VergataPrincipal Investigator

Lead Sponsor

University of Rome Tor VergataOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chron's disease patients with colorectal cancer		This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically	Procedure: Total proctocolectomy Procedure: Total colectomy Procedure: Segmental colectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total proctocolectomy	Procedure	excision of the whole large bowel including colon and rectum and end ileostomy fashioning	Chron's disease patients with colorectal cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	percentage of patients alive	5 years
disease free survival	percentage of patients disease free	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Crohn's disease complicated by occurrence of colorectal cancer, treated surgically between 01/2010 and 01/2020

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bruno Sensi, MD	Contact	3385352902		brunosensi@outlook.it
Giuseppe S Sica, MD, PhD	Contact	3385333659		sigisica@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Tor Vergata	Recruiting	Roma	RM	00133	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D015179	Colorectal Neoplasms
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016737	Proctocolectomy, Restorative

Ancestor Terms

ID	Term
D003082	Colectomy
D000099090	Surgical Procedures, Colorectal
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided