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Safety and Efficacy of Immune Therapy for Condyloma

Primary Purpose

Condylomata Acuminata

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DC-CIK immunotherapy
Sponsored by
Shenzhen Second People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Condylomata Acuminata focused on measuring DC-CIK, interferon

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Shenzhen Second HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DC-CIK+interferon Group

Placebo+interferon Group

Arm Description

dendritic cell-activated cytokine-induced killer cells (DC-CIK) immunotherapy plus interferon intervention

saline as placebo plus interferon intervention

Outcomes

Primary Outcome Measures

Condylomata Acuminata recurrence rate
Condylomata Acuminata recurrence rate in 6 months after treatment

Secondary Outcome Measures

skin tissue HPV gene
use PCR to testify skin tissue HPV gene
side effect
evaluate and record side effect of each group

Full Information

First Posted
May 16, 2017
Last Updated
June 28, 2017
Sponsor
Shenzhen Second People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03158480
Brief Title
Safety and Efficacy of Immune Therapy for Condyloma
Official Title
Safety and Efficacy of Immune Therapy for Condyloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Condylomata Acuminata
Keywords
DC-CIK, interferon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DC-CIK+interferon Group
Arm Type
Experimental
Arm Description
dendritic cell-activated cytokine-induced killer cells (DC-CIK) immunotherapy plus interferon intervention
Arm Title
Placebo+interferon Group
Arm Type
Placebo Comparator
Arm Description
saline as placebo plus interferon intervention
Intervention Type
Biological
Intervention Name(s)
DC-CIK immunotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Condylomata Acuminata recurrence rate
Description
Condylomata Acuminata recurrence rate in 6 months after treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
skin tissue HPV gene
Description
use PCR to testify skin tissue HPV gene
Time Frame
6 months
Title
side effect
Description
evaluate and record side effect of each group
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Facility Information:
Facility Name
Shenzhen Second Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lian Cuihong
Phone
15814692161
Email
15814692161@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Safety and Efficacy of Immune Therapy for Condyloma

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