Neoplasms, Uterine CervixNCT01221987
Cross-sectional Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Cervical Cancer
An observational study of Neoplasms, Uterine Cervix and Cervical Cancer, run by GlaxoSmithKline.
Trial summary
The current study will elucidate the human papillomavirus type distribution in a population of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical cancer in Sri Lanka. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Neoplasms, Uterine Cervix, Cervical Cancer
- What is being tested?
- Cervical sampling and Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Sep 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: Females > 21 years of age, diagnosed with invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe
Who may be able to join
- A female > 21 years of age at the time of diagnosis of invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe.
- Histologically confirmed diagnosis of cervix intraepithelial neoplasia - moderate or severe, invasive cervical cancer, glandular lesions and other epithelial tumours.
- Written informed consent obtained from the subject prior to study start.
- Subjects who the investigator believes can and will comply with the requirements of the protocol, should be enrolled in the study.
Who cannot join
- Previous vaccination against human papillomavirus.
- History of chemotherapy or radiotherapy for cervical cancer.
- Subjects with recurrent episodes of invasive cervical cancer or cervical intraepithelial neoplasia- moderate or severe.
About this study
Official title: A Cross-sectional, Hospital-based, Epidemiological Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) and/or Cervical Intraepithelial Neoplasia (CIN) II and/or CIN III in Sri Lanka
The current study will elucidate the human papillomavirus type distribution in a population of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical cancer in Sri Lanka.
- Conditions
- Neoplasms, Uterine Cervix, Cervical Cancer
- Being tested
- Cervical sampling, Data collection
- Keywords
- Human papillomavirus, neoplasia
- Medical subject headings
- Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical samplingProcedure or surgery
Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types
Data collectionOther
Questionnaire completion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Females > 21 years of age, diagnosed with invasive cervical cancer Receives: Procedure: Cervical sampling; Other: Data collection | |
| Cohort B | Females > 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia Receives: Procedure: Cervical sampling; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of human papillomavirus-16, human papillomavirus-18 in invasive cervical cancer and cervix intraepithelial neoplasia- moderate or cervix intraepithelial neoplasia- severe by short PCR fragment polymerase chain reaction and line probe assay
Measured: Up to 12 months from the date of study initiation
Secondary outcomes (3)
Detection of other high risk types in invasive cervical cancer and cervical intraepithelial neoplasia moderate or severe by short PCR fragment polymerase chain reaction and line probe assay
Measured: Up to 12 months from the date of study initiation
Occurrence of human papillomavirus-16, human papillomavirus-18 or other high risk types in relation to covariates
Measured: Up to 12 months from the date of study initiation
Detection of co-infection of human papillomavirus-16 and human papillomavirus-18 in relation to other high risk types
Measured: Up to 12 months from the date of study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, Uterine CervixStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221987
- Sponsor's protocol ID
- 110430
- Status last verified
- May 2011
- First submitted
- 14 Oct 2010
- Last updated
- 30 Apr 2012
- Results posted
- No
Publications
Karunaratne K, Ihalagama H, Rohitha S, Molijn A, Gopala K, Schmidt JE, Chen J, Datta S, Mehta S. Human papillomavirus prevalence and type-distribution in women with cervical lesions: a cross-sectional study in Sri Lanka. BMC Cancer. 2014 Feb 21;14:116. doi: 10.1186/1471-2407-14-116.
PubMed 24558979
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Hospital-based, Epidemiological Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) and/or Cervical Intraepithelial Neoplasia (CIN) II and/or CIN III in Sri Lanka
- ClinicalTrials.gov ID
- NCT01221987
- Acronym / sponsor ID
- 110430
- Conditions
- Neoplasms, Uterine Cervix, Cervical Cancer
- Keywords
- Human papillomavirus, neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Oct 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 current study will elucidate the human papillomavirus type distribution in a population of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical cancer in Sri Lanka.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: Cervical sampling, Other: Data collectionFemales > 21 years of age, diagnosed with invasive cervical cancer |
| Cohort B | – | Procedure: Cervical sampling, Other: Data collectionFemales > 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females > 21 years of age, diagnosed with invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe
Key inclusion criteria (4 listed)
- A female > 21 years of age at the time of diagnosis of invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe.
- Histologically confirmed diagnosis of cervix intraepithelial neoplasia - moderate or severe, invasive cervical cancer, glandular lesions and other epithelial tumours.
- Written informed consent obtained from the subject prior to study start.
- Subjects who the investigator believes can and will comply with the requirements of the protocol, should be enrolled in the study.
Key exclusion criteria (3 listed)
- Previous vaccination against human papillomavirus.
- History of chemotherapy or radiotherapy for cervical cancer.
- Subjects with recurrent episodes of invasive cervical cancer or cervical intraepithelial neoplasia- moderate or severe.
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 |
|---|---|---|
| Cervical samplingCervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types | Procedure or surgery | Cohort A, Cohort B |
| Data collectionQuestionnaire completion | Other | Cohort A, Cohort B |
Primary outcome
Detection of human papillomavirus-16, human papillomavirus-18 in invasive cervical cancer and cervix intraepithelial neoplasia- moderate or cervix intraepithelial neoplasia- severe by short PCR fragment polymerase chain reaction and line probe assay
Time frame: Up to 12 months from the date of study initiation
3 secondary outcomes
Detection of other high risk types in invasive cervical cancer and cervical intraepithelial neoplasia moderate or severe by short PCR fragment polymerase chain reaction and line probe assay
Time frame: Up to 12 months from the date of study initiation
Occurrence of human papillomavirus-16, human papillomavirus-18 or other high risk types in relation to covariates
Time frame: Up to 12 months from the date of study initiation
Detection of co-infection of human papillomavirus-16 and human papillomavirus-18 in relation to other high risk types
Time frame: Up to 12 months from the date of study initiation
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 30 Apr 2012.
- Derived from this study: PubMed 24558979Karunaratne K, Ihalagama H, Rohitha S, Molijn A, Gopala K, Schmidt JE, Chen J, Datta S, Mehta S. Human papillomavirus prevalence and type-distribution in women with cervical lesions: a cross-sectional study in Sri Lanka. BMC Cancer. 2014 Feb 21;14:116. doi: 10.1186/1471-2407-14-116.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Uterine Cervix and Cervical Cancer, run by GlaxoSmithKline.
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 3 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Detection of human papillomavirus-16, human papillomavirus-18 in invasive cervical cancer and cervix intraepithelial neoplasia- moderate or cervix intraepithelial neoplasia- severe by short PCR fragment polymerase chain reaction and line probe assay (time frame: Up to 12 months from the date of study initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01221987, which also lists 1 linked publication.
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 30 Apr 2012.