T-cell-immunity During Standard Radiotherapy in Localised... | NCT01376674

Studies
T-cell-immunity During Standard Radiotherapy in Localised Prostate Cancer

NCT01376674

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Aug 16, 2013Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

Germany

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

Aug 2013

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

Mar 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 16, 2011

First Submission Date that Met QC Criteria

Jun 16, 2011

First Posted Date

Jun 20, 2011Estimated

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, 2013

Last Update Posted Date

Aug 16, 2013Estimated

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

Immunological effects of radiotherapy have been described before, but not evaluated in a time-dependant manner.

In order to identify a possible time frame for combination therapies, white blood cells are isolated of samples taken at different time points before during and after standard radiotherapy in patients with localised prostate cancer. The overall activity of the T-cell-system as well as tumor-specific T-cell-response are evaluated.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

22Actual

Measure	Description	Time Frame
T-cell-immunity in time-course		During and 3-6 months after radiotherapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Localised prostate cancer (node negative)
definitive radiotherapy
informed consent

Exclusion Criteria:

medication including steroids or immunosuppressants

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing standard radiotherapy for localised prostate cancer at the University Hospital of Tuebingen

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cihan Gani, M.D.	University Hospital Tuebingen	Principal Investigator
Franziska Eckert, MD	University Hospital Tuebingen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiation Oncology		Tübingen		D-72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20715115	Background	Widenmeyer M, Shebzukhov Y, Haen SP, Schmidt D, Clasen S, Boss A, Kuprash DV, Nedospasov SA, Stenzl A, Aebert H, Wernet D, Stevanovic S, Pereira PL, Rammensee HG, Gouttefangeas C. Analysis of tumor antigen-specific T cells and antibodies in cancer patients treated with radiofrequency ablation. Int J Cancer. 2011 Jun 1;128(11):2653-62. doi: 10.1002/ijc.25601. Epub 2010 Oct 8.
34269847

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms