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Trial registered on ANZCTR


Registration number
ACTRN12617000726358
Ethics application status
Approved
Date submitted
18/01/2017
Date registered
18/05/2017
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of iodine solution administered via a treatment applicator for treating human papillomavirus (HPV) infection of the cervix.
Scientific title
Efficacy of iodine solution delivered through a delivery device for eradication of persistent HPV infection following treatment for high-grade cervical intraepithelial neoplasia.
Secondary ID [1] 290838 0
None
Universal Trial Number (UTN)
U1111-1191-3159
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical human papillomavirus infection 301514 0
Condition category
Condition code
Infection 301228 301228 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5% iodine solution will be applied to the cervix using a delivery device in a single outpatient treatment. Half of the recipients will have active treatment (iodine) and the other half placebo (saline Sodium Chloride injection 0.9% BP (90mg in 10mL) administered via the medical delivery device. The first 20 participants will receive the treatment for 10 minutes, the next 20 participants enrolled will receive the treatment for 15 minutes, and the final 20 participants will receive the treatment for 20 minutes. The treatment duration is only increased if a therapeutic response has not been demonstrated at an earlier time interval.. The treatment is to be administered by a gynaecologist in a hospital outpatient clinic. The treating gynaecologist determines the volume of iodine administered based on the size of the cervix, between 10ml and 30ml, The amount of iodine absorbed by each individual patient will depend on the size of the patients cervix and the patients individual diffusion rate for iodine. Assuming a 4-cm2 area saturated to a depth of 0.1mm the amount of iodine would be 0.002g. The delivery device consists of a tube with a balloon to be inserted into the endocervix. The balloon is then inflated to prevent solution entering the uterus and the solution is then delivered to the endocervix. A sponge saturated with additional iodine within a silicon cup is then applied to the outer cervix. Patients will be reminded of follow up appointments.
Intervention code [1] 296763 0
Treatment: Devices
Intervention code [2] 296764 0
Treatment: Drugs
Comparator / control treatment
Placebo using saline into the treatment device
Control group
Placebo

Outcomes
Primary outcome [1] 300640 0
Proportion of participants with an 80% reduction in human papillomavirus viral load on the uterine cervix. Measurements of viral load will be taken using a cervical lavage and a swab from the cervix.
Timepoint [1] 300640 0
6 weeks post treatment
Secondary outcome [1] 330479 0
None
Timepoint [1] 330479 0
None

Eligibility
Key inclusion criteria
Women previously treated for CIN 2 - 3 with persistent HrHPV post treatment.
Women Digene Hybrid Capture 2 positive (or other HPV test)
Women 25 year or over
Minimum age
25 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Under the age of 25
Male
Pregnancy, or planning to become pregnant
Current thyroid disease
Past history of thyroid disease
Family history of thyroid disease
History of allergy to iodine
History of allergy to rubber
History of anaphylaxis
Untreated gonorrhoea, or chlamydia
Current CIN 2 – 3 on cytology or biopsy
HIV infection or other immune deficiency
Impaired renal function
Autoimmune disorders
Systemic or topical steroid therapy
IUCD in situ

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study is a placebo controlled proof of concept study and based on work by Ho Y, Bierman R, Beardsley L, Chang C, Burk R. Natural history of cervicovaginal papillomavirus infection in young women. N Engl J Med. 1998; 336:423-8. Up to 60 women will be recruited and allow for a 20% drop out rate. The 10 patients in each group will be used to determine a treatment effect + standard deviation. This data will then be used to determine the number of patients that need to be treated to show an effect at a power (1) of at least 80% and < 0.05, provided the treatment has been found to be acceptable within the preceding treatment time interval. It is estimated there will be 20 patients in each treatment time group (10 active, 10 placebo). Data analysis will be with simple proportions using chi square analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
30/10/2019
Actual
Date of last data collection
Anticipated
30/04/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7202 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 14965 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 295267 0
Government body
Name [1] 295267 0
Health Department of Western Australia
Country [1] 295267 0
Australia
Primary sponsor type
Individual
Name
Jenny McClloskey
Address
Sexual Health Clinic
Royal Perth Hospital
BoxX2213 GPO Perth WA6847
Country
Australia
Secondary sponsor category [1] 294093 0
None
Name [1] 294093 0
Address [1] 294093 0
Country [1] 294093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296602 0
King Edward Memorial Hospital
Ethics committee address [1] 296602 0
374 Bagot Road
Subiaco 6008 WA, Australia
Ethics committee country [1] 296602 0
Australia
Date submitted for ethics approval [1] 296602 0
26/01/2016
Approval date [1] 296602 0
01/03/2016
Ethics approval number [1] 296602 0

Summary
Brief summary
World-wide cervical cancer is the fourth leading cause of cancer in women. Infection of the uterine cervix with human papillomavirus (HPV) is very common, with a small proportion of those infected progressing to cervical cancer. To date, no treatment of viral infection has been available and only the cell changes brought about by the virus relatively late in the infection are treated by one of the standard surgical methods which remove parts of the cervix affected by the virus.
This proof of concept research is to trial application of iodine via a novel delivery device to the upper vaginal vault, ectocervix (outside of the cervix) and endocervical canal (passage that leads from the cervix to the uterus). Women who have persisting HPV despite standard surgical treatment to the cervix are to be recruited and treated as an outpatient procedure, the trial assessing the duration of treatment required for successful eradication of the virus. Should the treatment be found to be effective, women at long term risk of acquiring cervical cancer or adenocarcinoma as a consequence of persistent HPV infection will be offered treatment to eradicate the infection, the HPV vaccine if unvaccinated, then returned to normal follow up as mandated by the accepted guidelines. Health savings will be significant to the WA government by offering a treatment that eradicates an infection linked to potential cancer development (not currently possible) and the necessary follow up the infection entails.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 71446 0
Dr Jenny McCloskey
Address 71446 0
Royal Perth Hospital
Box X2213, GPO Perth, WA 6847
Country 71446 0
Australia
Phone 71446 0
+61892243560
Fax 71446 0
+61892243557
Email 71446 0
[email protected]
Contact person for public queries
Name 71447 0
Dr Jenny McCloskey
Address 71447 0
Royal Perth Hospital
Box X2213, GPO Perth, WA 6847
Country 71447 0
Australia
Phone 71447 0
+61892243560
Fax 71447 0
+61892243557
Email 71447 0
[email protected]
Contact person for scientific queries
Name 71448 0
Dr Jenny McCloskey
Address 71448 0
Royal Perth Hospital
Box X2213, GPO Perth, WA 6847
Country 71448 0
Australia
Phone 71448 0
+61892243560
Fax 71448 0
+61892243557
Email 71448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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