Italian Multicenter Retrospective Observational Study on... | NCT02927756

Studies
Italian Multicenter Retrospective Observational Study on Transformed Lymphomas

NCT02927756

Sponsor

A.O.U. Città della Salute e della Scienza

Status

Unknown status

Last Update Posted

Nov 24, 2017Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Non-Hodgkin Lymphoma Transformed Recurrent

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2017Estimated

Primary Completion Date

May 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Sep 28, 2016

First Submission Date that Met QC Criteria

Oct 6, 2016

First Posted Date

Oct 7, 2016Estimated

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 22, 2017

Last Update Posted Date

Nov 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Barbara Botto, MD, A.O.U. Città della Salute e della ScienzaPrincipal Investigator

Lead Sponsor

A.O.U. Città della Salute e della ScienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Study purpose is to evaluate treatment outcome and survival in patient with aggressive lymphomas transformed from Follicular Lymphoma.

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

No data available

No data is available for this block.

Enrollment

180Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival	Time from last response to nearest relapse or follow-up	From first response to last follow-up for at least 2 years (up to 15 years)
Overall Survival	Time to last follow-up or death	Date of last follow-up for at least 2 years (up to 15 years)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed transformed Follicular Lymphoma
Age > 18 years
Histological transformation between January 2002 and December 2014
Availability of data about treatment and outcome

Exclusion Criteria:

Other lymphoma diagnosis

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

Adult patient with histologically confirmed diagnosis of Transformed Follicular Lymphoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Barbara Botto, MD	Contact	+390116334553		bbotto@cittadellasalute.to.it

Overall Officials

Name	Affiliation	Role
Barbara Botto, MD	A.O.U. Città della Salute e della Scienza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SC Ematologia - AOU Città della Salute e della Scienza di Torino	Recruiting	Torino		10126	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

paper publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058617	Composite Lymphoma
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018193	Neoplasms, Complex and Mixed

Browse Leaves

Not provided

Browse Branches

Not provided