Cytomegalovirus (CMV) Transmission and Immune Tracking (T... | NCT06522880

Studies
Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

NCT06522880

Sponsor

University of Massachusetts, Worcester

Status

Recruiting

Last Update Posted

Jul 26, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cytomegalovirus Infections

Interventions

CMV PCR on saliva

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

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

Jul 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

Aug 10, 2023Actual

Primary Completion Date

Jan 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 9, 2024

First Submission Date that Met QC Criteria

Jul 25, 2024

First Posted Date

Jul 26, 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

Jul 25, 2024

Last Update Posted Date

Jul 26, 2024Actual

Name	Class
ModernaTX, Inc.	INDUSTRY

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

The goal of STAGE I of the CMV TransmIT Study is to determine the prevalence of CMV shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. Participants will complete a health survey and provide one saliva sample for CMV PCR testing. In addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. These activities will inform the design of STAGE II.

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

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children		Children up to and including 36 months in large group childcare centers in the study network	Diagnostic Test: CMV PCR on saliva
Staff		All staff members in large group childcare centers attended by children participants	Diagnostic Test: CMV PCR on saliva

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CMV PCR on saliva	Diagnostic Test	Observational study to measure prevalence of CMV shedding by saliva PCR	Children Staff

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of CMV shedding	Prevalence of CMV shedding in children and childcare center staff. Shedding measured by CMV PCR on saliva.	Stage I up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Children

All children up to and including 36 months at time of signed consent regardless of duration of attendance at the center. Children living in the same household can each be enrolled.
Parent(s) has provided written informed consent for the child to be screened for CMV by saliva PCR collected at the center or at home

Center Staff

Individuals who regularly (average >/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time.
Staff member has provided written informed consent to be screened for CMV by saliva PCR collected at the center or at home

Exclusion Criteria

Children

>/= 37 months of age
State Department of Children and Families (DCF) custody

Center Staff

Do not regularly (average < 5 days per year) work inside the center
Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

36 Months

Standard Ages

Child

Study Population

Study participants will be recruited from all children and all staff at each center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laura Gibson, MD	Contact	5089813660		laura.gibson@umassmed.edu
Karen Del'Olio, MPH	Contact	5084718701		karen.del'olio@umassmed.edu

Overall Officials

Name	Affiliation	Role
Laura Gibson, MD	UMass Chan Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMass Chan Medical School	Recruiting	Worcester	Massachusetts	01655	United States

Condition Browse Module

MeSH Terms

ID	Term
D003586	Cytomegalovirus Infections

Ancestor Terms

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

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Browse Branches

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