Epidemiological Features and Clinical Course of COVID -19... | NCT04811781

Studies
Epidemiological Features and Clinical Course of COVID -19 Infection in Cancer Patients: The Rovid Study

NCT04811781

Sponsor

Istituto Oncologico Veneto IRCCS

Status

Completed

Last Update Posted

Nov 1, 2023Actual

Enrollment

761Actual

Phase

Not provided

Conditions

Solid Tumor, Adult

Interventions

Not provided

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

Oct 2023

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

Jun 4, 2020Actual

Primary Completion Date

Jun 4, 2021Actual

Completion Date

Jun 4, 2021Actual

First Submitted Date

Mar 19, 2021

First Submission Date that Met QC Criteria

Mar 22, 2021

First Posted Date

Mar 23, 2021Actual

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

Oct 31, 2023

Last Update Posted Date

Nov 1, 2023Actual

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 study aims to retrospectively collect epidemiological and clinical data in patients with solid tumors and SARS Covid2 infections belonging to oncology centers within the Veneto Oncology Network

Detailed Description

The aim of this study is to create a Veneto Oncology Network with the aim of collecting clinical and epidemiological data of cancer Patients affected by SAR- Covid-2 infection over a period of 1 year. Descriptive statistical approaches will be used to process the data.

The aim is to evaluate the development rate of severe clinical forms of infection in patients with SARS-Cov-2 and the possible association with tumour characteristics and treatment.

In addition, the results of serological tests can be compared with the outcome of the diagnostic swabs and the clinical evolution of the infection in order to obtain more information regarding the significance of specific antibody development.

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

761Actual

Label	Type	Description	Intervention Names
Cancer Patients with SARS-COV-2 infection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of SAR-COV2 infection development in association with tumor characteristics.		through study completion, an average of 18 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be 18 Years and older
cancer patients belonging to Veneto 's Oncological Network
Patients with SAR COV-2 infection

Exclusion Criteria:

Patients with no SAR COV2 Infection
Volunteers
No Cancer Patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Cancer patients with SAR COV-2 infection within the Veneto Oncology Network

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
istituto Oncologico Veneto -UOSD Melanoma		Padova	PD		Italy
Aulss1 Dolomiti