CTCs for High Grade Glioma | NCT02558335

Studies
CTCs for High Grade Glioma

NCT02558335

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Completed

Last Update Posted

Apr 24, 2020Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Stage III and IV Glioma Patients

Interventions

Not provided

Countries

United States

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

Apr 2020

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

Apr 2013Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2020Actual

First Submitted Date

Aug 19, 2015

First Submission Date that Met QC Criteria

Sep 22, 2015

First Posted Date

Sep 24, 2015Estimated

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

Apr 23, 2020

Last Update Posted Date

Apr 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. The current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or "swelling" of the tumor after treatment before it shrinks). Our hope is that CTCs will provide a more accurate description of tumor state for high grade glioma patients.

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

Retention

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to identify and quantify circulating tumor markers		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with biopsy-proven high grade glioma who are undergoing definitive radiotherapy as a part of their treatment regimen or patients with radiographic appearance of high grade glioma
Age 18 or older
Signed informed consent

Exclusion Criteria:

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

1. Patients with grade III and IV glioma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Lustig, MD	Abramsvaniaon Cancer Center of the University of Pennsyl	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States