SUV Max as Predictor of Outcome in Cervical Cancer | NCT01262144

Studies
SUV Max as Predictor of Outcome in Cervical Cancer

NCT01262144

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Dec 17, 2010Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Cervical Cancer

Interventions

Radiotherapy

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

Nov 2010

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

Aug 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 23, 2010

First Submission Date that Met QC Criteria

Dec 15, 2010

First Posted Date

Dec 17, 2010Estimated

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 15, 2010

Last Update Posted Date

Dec 17, 2010Estimated

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

Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease is identified are not usually eligible for surgery. PET-CT is used to support staging. However, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation.

This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent outcomes i.e. need for adjuvant therapy.

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

Not provided

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

50Estimated

Label	Type	Description	Intervention Names
Case group			Radiation: Radiotherapy

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation	Radiotherapy for cervical cancer	Case group

Measure	Description	Time Frame
Administration of adjuvant therapy		immediately following surgery

Measure	Description	Time Frame
Overall survival		surgery - present day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

having stating PET-CT stored on site
treated with surgery

Exclusion Criteria:

not eligible for surgery based on PET-CT, clinical stage

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Females age 18-80, diagnosed with cervical cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amnon Amit, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center		City	Haifa District		Israel

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided