Infections, PapillomavirusNCT01207999
Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer
An observational study of Infections, Papillomavirus and Cervical Cancer, run by GlaxoSmithKline at 5 sites in 3 countries.
Trial summary
The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Infections, Papillomavirus, Cervical Cancer
- What is being tested?
- Collection of cervical cancer tissue samples and Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 591 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged ≥ 21 years at the time the cervical specimen is taken, diagnosed with cervical lesion macroscopically suggestive of invasive cervical cancer, scheduled for cervical biopsy as per routine procedure.
Who may be able to join
- A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer.
- Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date.
- Written or oral-witnessed informed consent obtained from the subject prior to any study procedure.
- No prior chemo- or radiotherapy for cervical cancer.
Who cannot join
- Not applicable
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
South Africa1 site
GSK Investigational Site
Observatory, Western Province, 7935
About this study
Official title: Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer
The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.
- Conditions
- Infections, Papillomavirus, Cervical Cancer
- Being tested
- Collection of cervical cancer tissue samples, Data collection
- Keywords
- Human papillomavirus
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of cervical cancer tissue samplesProcedure or surgery
Cervical samples will be tested for histopathology diagnosis and human papillomavirus DNA testing.
Data collectionOther
Questionnaire completion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects diagnosed with invasive cervical cancer Receives: Procedure: Collection of cervical cancer tissue samples; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any of the human papillomavirus types (HPV-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with invasive cervical cancer
Measured: Average time frame: 6-12 months
Occurrence of any of the human papillomavirus types (human papillomavirus-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with squamous cell carcinoma
Measured: Average time frame: 6-12 months
Secondary outcomes (1)
Proportion of squamous cell carcinoma cases versus adenocarcinoma and other histologic tumour types of invasive cancer among the women diagnosed with invasive cervical cancer
Measured: Average time frame:6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startOct 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Cape Town, African Organization for Research and Training in Cancer (AORTIC)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207999
- Sponsor's protocol ID
- 109117
- Status last verified
- Nov 2012
- First submitted
- 22 Sep 2010
- Last updated
- 22 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer
- ClinicalTrials.gov ID
- NCT01207999
- Acronym / sponsor ID
- 109117
- Conditions
- Infections, Papillomavirus, Cervical Cancer
- Keywords
- Human papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- University of Cape Town, African Organization for Research and Training in Cancer (AORTIC)
- Study start
- Oct 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Collection of cervical cancer tissue samples, Other: Data collectionSubjects diagnosed with invasive cervical cancer |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged ≥ 21 years at the time the cervical specimen is taken, diagnosed with cervical lesion macroscopically suggestive of invasive cervical cancer, scheduled for cervical biopsy as per routine procedure.
Key inclusion criteria (4 listed)
- A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer.
- Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date.
- Written or oral-witnessed informed consent obtained from the subject prior to any study procedure.
- No prior chemo- or radiotherapy for cervical cancer.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of cervical cancer tissue samplesCervical samples will be tested for histopathology diagnosis and human papillomavirus DNA testing. | Procedure or surgery | Group A |
| Data collectionQuestionnaire completion | Other | Group A |
Primary outcome
Occurrence of any of the human papillomavirus types (HPV-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with invasive cervical cancer
Time frame: Average time frame: 6-12 months
Occurrence of any of the human papillomavirus types (human papillomavirus-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with squamous cell carcinoma
Time frame: Average time frame: 6-12 months
1 secondary outcome
Proportion of squamous cell carcinoma cases versus adenocarcinoma and other histologic tumour types of invasive cancer among the women diagnosed with invasive cervical cancer
Time frame: Average time frame:6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
Related trials for Infections, Papillomavirus
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Papillomavirus and Cervical Cancer, run by GlaxoSmithKline at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ghana, Nigeria, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any of the human papillomavirus types (HPV-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with invasive cervical cancer (time frame: Average time frame: 6-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.