How to Differentiate and Treat Cystic Laesions in the Ant... | NCT05839678

Studies
How to Differentiate and Treat Cystic Laesions in the Anterior Mediastinum (DETECTION)

NCT05839678

Sponsor

Maastricht University Medical Center

Status

Recruiting

Last Update Posted

Nov 20, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Cysts

Interventions

Not provided

Countries

Netherlands

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

Nov 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 1, 2022Actual

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Apr 20, 2023

First Submission Date that Met QC Criteria

Apr 20, 2023

First Posted Date

May 3, 2023Actual

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

Nov 18, 2024

Last Update Posted Date

Nov 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Florit Marcuse, Principal investigator, MD PhD, Maastricht University Medical CenterPrincipal Investigator

Lead Sponsor

Maastricht University Medical CenterOTHER

Collaborators

Name	Class
Erasmus Medical Center	OTHER
The Netherlands Cancer Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage correctly diagnosed cystic laesions		2000-2022

Secondary Outcomes

Measure	Description	Time Frame
Patient characteristics, complications, comborbidities		2000-2022

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: cysts in the anterior mediastinum

Thymic cysts
Bronchogenic cysts
Pericardial cysts
Cystic thymoma
Cystic teratoma

Exclusion Criteria:

Patients <18 years old
Patients without radiological imaging
Patients without approval for follow-up

Accepts Healthy Volunteers

Not provided

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 cysts in the anterior mediastinum

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht UMC	Recruiting	Maastricht	Limburg		Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003560	Cysts

Ancestor Terms

ID	Term
D009369	Neoplasms
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided