Family Members At INcreased-risk for Developing Inflammat... | NCT06655415

Studies
Family Members At INcreased-risk for Developing Inflammatory Bowel Disease

NCT06655415

Sponsor

Massachusetts General Hospital

Status

Recruiting

Last Update Posted

Dec 20, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Inflammatory Bowel Disease (IBD)
Ulcerative Colitis (UC)
IBD-unclassified (IBD-U)
Indeterminate Colitis
Crohn's Disease Colon
Crohn's Colitis
Crohn's Ileocolitis
Crohn's Gastritis
Crohn's Jejunitis
Crohn's Duodenitis
Crohn's Esophagitis
Ulcerative Proctitis
Ulcerative Proctosigmoiditis

Interventions

Not provided

Countries

United States

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

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2024Actual

Primary Completion Date

Dec 2034Estimated

Completion Date

Dec 2034Estimated

First Submitted Date

Oct 21, 2024

First Submission Date that Met QC Criteria

Oct 22, 2024

First Posted Date

Oct 23, 2024Actual

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 18, 2024

Last Update Posted Date

Dec 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emily R. Lopes, MD, MPH, Principal Investigator, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

First-degree relatives of people with inflammatory bowel disease ("IBD," including Crohn's disease and ulcerative colitis) have an increased risk for developing IBD themselves. This study will follow unaffected first-degree relatives (who do not have IBD) over time to understand if their behaviors, diet, and biomarkers for IBD can help predict who gets IBD and if IBD can be prevented in these high-risk individuals. Participants will be asked once per year to complete a questionnaire and have their blood, stool, and urine collected. The anticipated length of the study (registry) is approximately 10 years or longer. Parts of this study, such as the questionnaires and stool and urine collection, may be done from home, while other parts, such as the blood draw, will need to be done from Massachusetts General Hospital.

Detailed Description

Not provided

Conditions Module

Conditions

Inflammatory Bowel Disease (IBD)
Ulcerative Colitis (UC)
IBD-unclassified (IBD-U)
Indeterminate Colitis
Crohn's Disease Colon
Crohn's Colitis
Crohn's Ileocolitis
Crohn's Gastritis
Crohn's Jejunitis
Crohn's Duodenitis
Crohn's Esophagitis
Ulcerative Proctitis
Ulcerative Proctosigmoiditis

Keywords

Inflammatory Bowel Disease
IBD
Ulcerative colitis
Crohn's disease

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Individuals who have a parent, sibling, or child with IBD but who do not have IBD themselves		Adult and adolescent (greater than 14 years of age) first-degree relatives (parents, siblings, or children) of patients with inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or inflammatory bowel disease-unclassified/indeterminate colitis) but who do not have inflammatory bowel disease themselves.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants who develop inflammatory bowel disease	Participants will be queried annually on questionnaires for the development of inflammatory bowel disease (IBD), including Crohn's disease, ulcerative colitis, or IBD-U (self-reported outcome). Participants will then be asked for permission to obtain additional medical records, which will be reviewed by study investigators to confirm diagnosis of IBD.	Through study completion (an anticipated 10 years)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to give informed consent
Ability to complete all study visits and study-related procedures
Ability to understand and complete study questionnaires
Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or IBD-unclassified)
Age ≥ 14

Exclusion Criteria:

Individuals with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or IBD-unclassified)
Evidence of clinical signs or symptoms of IBD, which will be identified on pre-screening interview with the study coordinator.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

First-degree relatives (FDRs) of those with IBD.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emily W Lopes, MD, MPH	Contact	617-726-5560		mghfindibd@mgb.org

Overall Officials

Name	Affiliation	Role
Emily W Lopes, MD, MPH	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital	Recruiting	Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified data may be available upon reasonable request and per Mass General Brigham IRB guidelines as outlined in the ICF and detailed protocol.

Types

Not provided

Time Frame

Not provided

Access Criteria

Collaborators interested in requesting data must submit a valid scientific question, include a statistical analysis plan, complete a data request form, and Data Use Agreement (DUA), which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data.

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D015212	Inflammatory Bowel Diseases
D003093	Colitis, Ulcerative
D003424	Crohn Disease

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases
D003092	Colitis
D003108	Colonic Diseases