Safety and Efficacy of Immune Therapy for Condyloma

June 28, 2017 updated by: Shenzhen Second People's Hospital
Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata patients only use interferon.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen Second Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:All patients have typical clinical characters of condyloma, positive for HPV-DNA test; All patients have been treated for cryotherapy or laser plus interferon for over half a year without completely recovery. All patients or their family will sign informed consent and approved by Ethics Committee of Shenzhen Second People's Hospital -

Exclusion Criteria:pregnant, blood disease, contraindication for immune therapy, allergic to interferon

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DC-CIK+interferon Group
dendritic cell-activated cytokine-induced killer cells (DC-CIK) immunotherapy plus interferon intervention
Biological: DC-CIK immunotherapy
Cytokine-induced killer (CIK) cells are co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to condylomata acuminata patients
Placebo Comparator: Placebo+interferon Group
saline as placebo plus interferon intervention
Biological: DC-CIK immunotherapy
Cytokine-induced killer (CIK) cells are co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to condylomata acuminata patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Condylomata Acuminata recurrence rate
Time Frame: 6 months
Condylomata Acuminata recurrence rate in 6 months after treatment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin tissue HPV gene
Time Frame: 6 months
use PCR to testify skin tissue HPV gene
6 months
side effect
Time Frame: 6 months
evaluate and record side effect of each group
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Second People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20173357201827

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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