Using Pleural Effusions to Diagnose Cancer | NCT03319472

Studies
Using Pleural Effusions to Diagnose Cancer

NCT03319472

Sponsor

University of Patras

Status

Completed

Last Update Posted

Dec 10, 2019Actual

Enrollment

439Actual

Phase

Not provided

Conditions

Pleural Effusion

Interventions

Not provided

Countries

Greece

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2013Actual

Primary Completion Date

Nov 21, 2017Actual

Completion Date

Nov 21, 2018Actual

First Submitted Date

Oct 19, 2017

First Submission Date that Met QC Criteria

Oct 19, 2017

First Posted Date

Oct 24, 2017Actual

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 8, 2019

Last Update Posted Date

Dec 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georgios Stathopoulos, Associate Professor of Physiology, University of PatrasPrincipal Investigator

Lead Sponsor

University of PatrasOTHER

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

Pleural effusions (PE) are common conditions that signal either infection or cancer. The investigators aim to develop, validate, and prospectively assess the MAPED score, a clinical score that predicts malignancy at admission. This tool will assist clinicians all over the world to rapidly assess the probability of an effusion being malignant within 4 hours of admission.

Detailed Description

Background: Pleural effusions (PE) are common conditions that signal either pleural-disseminated infection or cancer. While these diagnoses bear tremendous importance for patients, they require invasive procurement of pleural tissues and/or cells and time. Simple and rapid diagnostic markers of pleural malignancy at admission that streamline diagnostic and treatment efforts remain unidentified.

Objective: To develop, validate, and prospectively assess markers of malignancy of PE at admission.

Methods: A prospective cohort of patients with PE from different etiologies will be recruited stating on 11.21.2013 and prospectively ending on 11.21.2023. Data will be collected within 4 hours of admission including history, chest X-ray, and blood and pleural fluid (PF) cell counts and basic biochemistry. Pleural fluid and serum will be biobanked for future analyses. Patients will sign informed consent forms. Diagnosis will be confirmed using standard microbiology, cytology, histology, and imaging techniques. Patients undiagnosed within a month will be excluded. Variables will be entered into binary regression and receiver-operator analyses using malignancy as the target to develop the MAPED score, a clinical score that predicts malignancy at admission. MAPED will be retrospectively validated in separate published cohorts from the first therapeutic interventions in malignant effusion (TIME) 1-3 trials from Oxford UK. Data will be censored and analyzed three times, at 40-month intervals since study initiation.

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

439Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benign Pleural Effusion		Patients that will be diagnosed within a month from admission with any non-malignant cause of pleural effusion, including but not limited to effusions caused by common or tuberculous or fungal infection, heart failure, etc. Documentation of the etiology will be required for inclusion in this group, including but not limited to bacteriology, virology, PCR, radiology, heart echocardiogram or catheterization, as appropriate.
Malignant Pleural Effusion		Patients that will be diagnosed within a month from admission with any malignant cause of pleural effusion, including but not limited to effusions caused by lung, breast, colon, ovary, mesothelial, hematopoietic, prostate, or any other cancer. Diagnosis will be based on verification of the presence of malignant cells in the pleural fluid or tissues. Patients with cancer and an effusion without such documentation will be assigned to the benign group if an alternative diagnosis is made. In any other case, they will be excluded.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of Malignancy	Cytologic or histologic evidence of malignant cells or tissues in the pleural space.	One month post-admission

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pleural effusion
Hospital admission
No previous pleural procedure
Age > 18 years
No previous chemoradiotherapy
No antibiotic therapy during previous trimester
All history, chest X-ray, and pleural and blood cell counts and biochemistry entry data obtained within 4 hours after admission

Exclusion Criteria:

No diagnosis at one month post-admission
No informed consent provided
Age < 18 years
History, chest X-ray, or pleural and blood cell counts and biochemistry entry data obtained later than 4 hours after admission

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

All patients admitted to a tertiary hospital with a pleural effusion.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georgios T Stathopoulos, MD, PhD	Associate Professor of Physiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Patras University Hospital		Rio	Achaia	26504	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 8, 2021
Reset	May 4, 2021

Submission Tracking

Estimated Results First Submitted Date

Apr 8, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 8, 2021			May 4, 2021

Condition Browse Module

MeSH Terms

ID	Term
D010996	Pleural Effusion
D009369	Neoplasms
D005215	Fasting

Ancestor Terms

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Pleural fluid will be centrifuged and cells will be separated from supernatants. The latter will be stored together with matched serum samples at -80 degrees C. Cell pellets will be stored in DMEM 10% FBS, 2 % DMSO at the same temperature.