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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a longitudinal observational study of women presenting to Groote Schuur Hospital with genital warts. The study will evaluate the socio-demographic characteristics of the women using a structured questionnaire. It will also document the site and extend of the genital warts and genotyping will be performed on the warts. HIV status will be determined with patient consent, treatment modalities will be documented as will the outcome of treatment over a 6 month's period. Risk factors for recurrence or failure of treatment will be analysed as will the costs of treating women with genital warts.
Genital Human Papillomavirus (HPV) infection is the most common sexually transmitted viral disease in the world.1,2 HPV infection on genital epithelia is associated with a range of disease spectra, from visible lesions such as genital warts, cervical, vaginal, vulval, anal and penile intraepithelial cancers and their precursors, or they may co- exist in the latent form in apparently normal epithelium.3,4 It is established that genital warts are associated with low-risk HPV genotypes, with the causative agents being HPV-6 and HPV-11 in almost 100% of cases.5 However, recent studies have shown that 20 to 50% of lesions also contain co-infection with high-risk HPV types.6,7
Although genital warts are not life-threatening, they cause significant psychosocial morbidities resulting in low self-esteem, negative self-perception, embarrassment and anxiety.8,9 Genital warts also represent not only a health problem for the individual, but also an economic burden for society as they carry a high and immediate financial burden and health care cost due to their generally recalcitrant response to conventional therapies.9 With this in mind, immunization with HPV 6/11/16/18 recombinant vaccine holds promise for reducing overall burden on clinical HPV-related diseases.
Genital warts are a common cause for referral to the Colposcopy Clinic of Groote Schuur Hospital, Cape Town which is a tertiary hospital serving the wider Cape Town area and the Western Cape Province. With an increasing number of cases seen requiring multiple clinical visits for treatment and a high number of recurrent and persistent cases, we undertook this study to examine the nature of the disease from a clinical point of view, response to various therapies, the impact of HIV and the types of HPV causing or associated with genital warts in women referred to our clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genital Warts | All female patients with Genital Warts presenting to Groote Schuur Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical / Surgical Treatment | Procedure | All participants received treatment based on the morphology and distributions of lesions. For the treatment with Trichloroacetic Acid (TCA), patients were advised to attend the clinic weekly until no visible lesions seen. For electrosurgery or laser, patients were given a date for admission a day prior to surgery. Post-operatively, she remained in the ward for at least five days. |
| Measure | Description | Time Frame |
|---|---|---|
| HPV DNA and HIV Status | HPV DNA Positivity and HIV Status | 18 Months |
| HPV DNA and Pap Smear Results | Relationship between HPV DNA Positivity and Pap Smear Results | 18 Months |
| Number of HPV Genotypes Isolated by HIV Status | Number of HPV Genotypes isolated according to HIV Status | Up to 18 months |
| Commonest HPV Genotypes Isolated by HIV Status | 10 commonest types of HPV isolated according to HIV status | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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All female patients with Genital Warts presenting to Groote Schuur Hospital, Cape Town
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| Name | Affiliation | Role |
|---|---|---|
| Shahila Tayib, MBChB | University of Cape Town | Principal Investigator |
| Lynette Denny | University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groote Schuur Hospital | Cape Town | Western Cape | 7925 | South Africa |
No Applicable.
All female patients with genital warts referred to the Colposcopy Clinic of Groote Schuur Hospital, Cape Town, South Africa between 1st April 2010 and 30 September 2010. Those who were pregnant or too frail or ill for a gynaecological examination were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Number of Participants | Participants with Genital Warts |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | New Cases | Newly diagnosed cases of genital warts |
| BG001 | Recurrent Cases | Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HPV DNA and HIV Status | HPV DNA Positivity and HIV Status | Only 126 out of 156 samples collected from each patients were analysed as 30 of the samples were contaminated, of which 22 were from HIV Positive patients and 8 were from HIV Negative patients. | Posted | Number | participants | 18 Months |
|
1 year and 10 months
Adverse event here referred to developement of warts recurrent after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV Positive | Participants with Genital Warts who were HIV Positive |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Warts Recurrence | Skin and subcutaneous tissue disorders | Others | Non-systematic Assessment | Patients recruited were seen at 3 and 6 months post-treatmeant to assess warts recurrence. |
Thirty (19.2%) specimens had to be rejected due to contamination that occurred during the analysis process. During the HPV DNA analysis, there were protocols for different aspect of controls during the analysis which needed to be negative.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Shahila Tayib | Groote Schurr Hospital / University of Cape Town | 0060195773376 | syarq@yahoo.com |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| BG002 | Persistent Cases | The warts presence after completion of treatment |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Marital Status | Number | Participants |
|
| Age at First Sexual Intercourse | Number | Participants |
|
| Education Level | Number | Participants |
|
| Smoking | Number | Participants |
|
| HIV Status | Number | Participants |
|
| Treatment Modalities | Number | Participants |
|
Number of participants who refused HIV Testing |
|
|
| Primary | HPV DNA and Pap Smear Results | Relationship between HPV DNA Positivity and Pap Smear Results | Only 118 out of 119 patients with HPV DNA Positive had a Pap Smear done. One patient was a Virgin and hence no Pap Smear was done. | Posted | Number | Participants | 18 Months |
|
|
|
| Primary | Number of HPV Genotypes Isolated by HIV Status | Number of HPV Genotypes isolated according to HIV Status | 119 out of 126 uncontaminated samples were HPV DNA Positive. Out of these 119 HPV DNA Positive Samples, 12 were B-Globin Positive but no specific HPV Genotype could be identifiable. | Posted | Number | participants | Up to 18 months |
|
|
|
| Primary | Commonest HPV Genotypes Isolated by HIV Status | 10 commonest types of HPV isolated according to HIV status | Posted | Number | Participants | 18 months |
|
|
|
| 0 |
| 123 |
| 28 |
| 123 |
| EG001 | HIV Negative | Participants with Genital Warts who were HIV Negative | 0 | 29 | 5 | 29 |
| EG002 | HIV Unknown | Participants with Genital Warts whom HIV Status was Unknown | 0 | 4 | 0 | 4 |
|
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| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| High Grade Squamous Intraepithelial Lesion |
|
| Atypical Squamous Cell of Undetermined Significanc |
|
| Title | Measurements |
|---|---|
|
| 3 HPV Genotype |
|
| 4 HPV Genotype |
|
| 5 HPV Genotype |
|
| 6 HPV Genotype |
|
| 7 HPV Genotype |
|
| 8 HPV Genotype |
|
| 9 HPV Genotype |
|
| 11 HPV Genotype |
|
| 15 HPV Genotype |
|
| No Genotype Isolated but B-Globin Positive |
|
| HPV 89 |
|
| HPV 61 |
|
| HPV 55 |
|
| HPV 62 |
|
| HPV 81 |
|
| HPV 16 |
|
| HPV 18 |
|
| HPV 45 |
|