A Data Collection Study for Patients With Adenocarcinoma Treated With the MyVaccx Immunotherapy Regimen.

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

April 11, 2018

Estimated Primary Completion Date

July 27, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

MyVaccx immunotherapy treatment impact on late stage cancer disease[ Time Frame: From date of treatment until the date of death from any cause up to 60 months ]

Time to death after the start of treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

MyVaccx immunotherapy treatment impact on late stage cancer disease[ Time Frame: Time to progression after a complete or partial response up to 60 months ]
Complete and partial response to treatment based on the iRESIST criteria

Descriptive Information

Brief Title ^ICMJE

A Data Collection Study for Patients With Adenocarcinoma Treated With the MyVaccx Immunotherapy Regimen.

Official Title ^ICMJE

A Retrospective and Prospective Study of a New Immunotherapy Regimen (MyVaccx) for Patients With Adenocarcinoma.

Brief Summary

A retrospective and prospective data collection study on 17 consecutive subjects with adenocarcinoma who were treated using the MyVaccx system by Dr. Gary Onik. Retrospective data was collected on the treatment with the immunotherapy system and prospective data will be collected as they are prospectively monitored through their normal standard of care for their original cancer.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Drug: Immunotherapeutic Agents
Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents
Device: Ablation
Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents

Study Arms

: Adenocarcinoma treated with MyVaccx
MyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease..

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2025

Estimated Primary Completion Date

July 27, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Treatment with the MyVaccx System - Greater than 18 years of age - Signature of the informed consent Exclusion Criteria: - 2 subjects treated with the MyVaccx System with known visceral disease

Sex/Gender

Sexes Eligible for Study:

All

Ages

19 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

，

Study Sponsor ^ICMJE

Gary Onik MD

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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