Sonographic Characteristics of Tumor Indices in Patients... | NCT01562067

Studies
Sonographic Characteristics of Tumor Indices in Patients With Cervical Cancer During Chemo-radiotherpy

NCT01562067

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Mar 23, 2012Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Cancer

Interventions

ultrasound examination

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

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Mar 21, 2012

First Submission Date that Met QC Criteria

Mar 22, 2012

First Posted Date

Mar 23, 2012Estimated

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

Mar 22, 2012

Last Update Posted Date

Mar 23, 2012Estimated

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 tumors are characterized by vascular changes (in terms of quantity, volume and Flows) in the tumor. Due to a good access to the cervix through the vagina, these parameters can be assessed using a three dimensional supersonic. Sonographic characteristics of tumor indices measures before and after oncological treatments may shed light on the patient's prognosis.

Detailed Description

no editional information. see above

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

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound examination	Device	ultrasound and doppler studies to evaluate size and vascularity of tumor during radiotherapy		no other name

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sonographic characteristics of cervical tumors	Sonographic characteristics of cervical tumors indices measures before and after oncological treatments may shed light on the patient's prognosis.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cervical cancer patients intended to undergo chemotherapy or radiation, or both

Exclusion Criteria:

no exclusions

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

women with cervical cancer during radiotherapy

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		Haifa		30196	Israel

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided