The Prognostic Value of Interim PET/CT After 2 Cycles of... | NCT00498667

Studies
The Prognostic Value of Interim PET/CT After 2 Cycles of Chemotherapy in Predicting Progression of Non Hodgkins Lymphoma

NCT00498667

Sponsor

Rambam Health Care Campus

Status

Withdrawn

Last Update Posted

May 6, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse

Interventions

Not provided

Countries

Israel

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

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jul 8, 2007

First Submission Date that Met QC Criteria

Jul 8, 2007

First Posted Date

Jul 10, 2007Estimated

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

May 5, 2015

Last Update Posted Date

May 6, 2015Estimated

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

A retrospective analysis will be performed regarding the usefulness of PET/CT performed following 2 cycle of chemotherapy in evaluation of progression, free survival and overall survival of patients with aggressive non Hodgkin Lymphoma.

Detailed Description

Patients who were treated for aggressive non-Hodgkin lymphoma with adriamycin containing regimen, CHOP and High dose CHOP with or without rituximab were evaluated post 2 cycles of chemotherapy to rule out disease progression . Currently a retrospective evaluation of PET/CT as a predictive value for progression free survival and overall survival is evaluated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PET/CT		all patients with aggressive lymphoma who had a baseline and interim pet/ct study

Interventions

Not provided

Measure	Description	Time Frame
progression free survival		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aggressive non-Hodgkin lymphoma b cells
age 18-70
bilirubin less then 2
creatinine less then 2
Pet/CT performed post 2 cycles

Exclusion Criteria:

no PET/CT post 2 cycles performed
bilirubin >2
creatinine more then 2
HIV positivity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

all patients with agressive non hodgkin lymphoma who had interim pet/ct during therapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eldad J Dann, MD	RAMBAM health care campus,Rappaport faculty of medicine Technion Israel Technical institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RAMBAM health care Campus		Haifa		31096	Israel

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided