Blood Test to Predict Radiation Response and Toxicity in... | NCT03142425

Studies
Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy

NCT03142425

Sponsor

DxTerity Diagnostics

Status

Unknown status

Last Update Posted

Feb 7, 2019Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Radiation Therapy

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

ID	Type	Description	Link
261201600051C-0-0-1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2019

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

Jun 19, 2017Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Apr 25, 2017

First Submission Date that Met QC Criteria

May 3, 2017

First Posted Date

May 5, 2017Actual

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

Feb 6, 2019

Last Update Posted Date

Feb 7, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Collect blood samples and associated clinical data prior to and post radiation treatment.

Detailed Description

Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.

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

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of blood samples from patients prior to and post irradiation treatment.	Explore and validate a radiation sensitivity test for determining radiation treatment tumor response by refining and analyzing gene expression signature of blood samples collected from 150 patients prior to and post irradiation treatment.	Up to 4 months, from informed consent through follow up activities.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients age 18 or older
Diagnosed with a primary rectal or esophageal cancer
Planned radiation therapy to the esophagogastric area to a minimum of 4140 cGy for esophageal/gastroesophageal junction cancer or to pelvis to a minimum of 4500 cGy for rectal cancer as part of clinical care
Combining chemotherapy is allowed
ECOG Performance Status 0-2
Able to provide written informed consent

Exclusion Criteria:

Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent
Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of the study

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

Male and female patients, age 18 or older, diagnosed with a primary rectal or esophageal/gastroesophageal junction cancer undergoing radiation therapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Arruda, B.S.	Contact	310-537-7857		aarruda@dxterity.com
Kristen Warren, B.S.	Contact	310-537-7857		kwarren@dxterity.com

Overall Officials

Name	Affiliation	Role
Robert Terbrueggen, PhD	President and CEO	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope	Recruiting	Duarte	California	91010	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided