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Status unknownNCT03158480Updated Jun 29, 2017

Safety and Efficacy of Immune Therapy for Condyloma

An interventional study of DC-CIK immunotherapy in Condylomata Acuminata, sponsored by Shenzhen Second People's Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-06-29.

Sponsored by Shenzhen Second People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Condylomata Acuminata

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Keywords

  • DC-CIK
  • interferon
03

In context

Condylomata Acuminata

94 studies on the registry are indexed under Condylomata Acuminata; 7 are open to participants now.

This study's planned enrollment of 80 is below the median of 140 across 77 interventional studies indexed under Condylomata Acuminata.

Browse Condylomata Acuminata studies →

Lead sponsor

Shenzhen Second People's Hospital is the lead sponsor of 48 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
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

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    DC-CIK+interferon Group

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

    Biological: DC-CIK immunotherapy

  • Placebo comparator
    Placebo+interferon Group

    saline as placebo plus interferon intervention

    Biological: DC-CIK immunotherapy

Interventions

  • BiologicalDC-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

06

What researchers measure

Primary outcomes

  1. Condylomata Acuminata recurrence rate

    Condylomata Acuminata recurrence rate in 6 months after treatment

    Time frame: 6 months

Secondary outcomes

  1. skin tissue HPV gene

    use PCR to testify skin tissue HPV gene

    Time frame: 6 months

  2. side effect

    evaluate and record side effect of each group

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Shenzhen Second Hospital
    Shenzhen, Guangdong, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03158480
Lead sponsor
Shenzhen Second People's Hospital
Responsible party
Sponsor
First posted
May 18, 2017
Start date
Jun 25, 2017
Primary completion
Dec 31, 2018 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
Jun 29, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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