Anti-tumor Immune Response in Patients With Cancer Underg... | NCT02310594

Studies
Anti-tumor Immune Response in Patients With Cancer Undergoing Radiation Therapy

NCT02310594

Sponsor

Jonsson Comprehensive Cancer Center

Status

Terminated

Last Update Posted

Aug 18, 2022Actual

Enrollment

139Actual

Phase

Not provided

Conditions

Malignant Neoplasm

Interventions

cytology specimen collection procedure
laboratory biomarker analysis

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
NCI-2014-02231	Registry Identifier	CTRP (Clinical Trial Reporting Program)
10-001588-CR-00004	Other Identifier	Jonsson Comprehensive Cancer Center
Steinberg122308
09-01-010	Other Identifier	Jonsson Comprehensive Cancer Center

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual

Expanded Access Info

Start Date

Jul 8, 2010Actual

Primary Completion Date

Aug 9, 2022Actual

Completion Date

Aug 9, 2022Actual

First Submitted Date

Nov 13, 2014

First Submission Date that Met QC Criteria

Dec 4, 2014

First Posted Date

Dec 8, 2014Estimated

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

Aug 15, 2022

Last Update Posted Date

Aug 18, 2022Actual

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

This research trial studies the effect of radiation therapy on tumor immunity. Standard radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this response is often ineffective in shrinking tumor tissue. Collecting samples of blood from patients before, during, and after radiation therapy to study in the laboratory may help doctors learn more about the effects of radiation therapy on anti-tumor response.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the effect of radiation therapy on tumor immunity.

OUTLINE:

Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.

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

139Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ancillary-Correlative (blood banking)		Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.	Other: cytology specimen collection procedure Other: laboratory biomarker analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cytology specimen collection procedure	Other	Undergo blood sample collection	Ancillary-Correlative (blood banking)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Outcome measures include changes in tumor-specific immune responses and general immune signature in patients undergoing Radiation Treatment. Reportable endpoints are absolute values of and changes in innate & adaptive immune cells and serum markers.		The time line of interest covers a baseline, pre-treatment sample as well as mid-treatment and a post-treatment, follow-up sample at 3 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed and dated Institutional Review Board (IRB)-approved Informed Consent form for the study
Received an explanation of the study, including satisfactory answers to all questions related to the proposed research
Is undergoing physician directed radiation treatment

Exclusion Criteria:

The potential Subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent form

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

Adult cancer patients undergoing physician directed radiation treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Steinberg	Jonsson Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jonsson Comprehensive Cancer Center		Los Angeles	California	90095	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Description

The tentative assumption is that cell death following radiation therapy will stimulate anti-tumor immunity, which could provide a more permanent solution to curing cancer and discouraging tumors from spreading throughout the body. In order to find out if this assumption is correct, highly developed, laboratory analyses for tumor-specific immunity will be performed using the white blood cells, while the blood components that are soluble, will be frozen and stored, to be examined at a later time for evidence of molecules of anti-tumor immunity that have been induced by radiation therapy.