Characterization of Cancer Tissue Using 3D Biosynthetic M... | NCT02678078

Studies
Characterization of Cancer Tissue Using 3D Biosynthetic Material

NCT02678078

Sponsor

Technion, Israel Institute of Technology

Status

Unknown status

Last Update Posted

May 6, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Analyzing biopsy samples

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 2016

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

Feb 2016

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Feb 4, 2016

First Submission Date that Met QC Criteria

Feb 8, 2016

First Posted Date

Feb 9, 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

May 5, 2016

Last Update Posted Date

May 6, 2016Estimated

Name	Class
Rambam Health Care Campus	OTHER

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

Characterization of Cancer Tissue Using 3D Biosynthetic Materials. Using liver biopsy from stage 4 cancer patients, the investigators will evaluate and characterize the metastatic cells.

Detailed Description

The investigators' biomaterial lab has developed an in vitro diagnostic system in which a cancer tumor is placed inside a 3D hydrogel. This material has similar properties to the human tissue and can visualize cell migration and proliferation. In this system, the investigators have already characterised human metastatic cells obtained from nude mice tumors. The diagnostic assay is able to evaluate the reduction in cell growth associated with anti-cancer drug therapy. The next step is to test the in vitro diagnostic system using human tissue samples from human patients, and to validate the system as a simple and effective a priori diagnostic tool for characterizing patient tumours.

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

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Analyzing biopsy samples	Procedure	Analyzing biopsy samples that is preformed as part of the patient treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cell growth	biopsy will be placed inside 3D gel, and growth will be measured over 1 week time.	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

liver tumor

Exclusion Criteria:

refuse to volunteer

Accepts Healthy Volunteers

Yes

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

every man or women 18 years old or older, with a liver tumor.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
tarek Saadi, Dr.	Contact	97247772947		t_saadi@rambam.health.gov.il
shlomit harpaz, Msc	Contact	972544565257		shlomith@tx.technion.ac.il

Overall Officials

Name	Affiliation	Role
Dror seliktar, Prof	Technion, Israel Institute of Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam	Recruiting	Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D004194	Disease

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided