Human Papillomavirus (HPV) Type Distribution in Adult Women Diagnosed With Invasive Cervical Cancer in New Zealand

An observational study of Cervical Cancer, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to assess the distribution of the most frequent types of human papillomavirus in women diagnosed with invasive cervical cancer in New Zealand. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Cancer
What is being tested?: Testing of archived cervical cancer tissue samples and Data collection
How many people: 244 participants
Where: No sites listed yet
Study dates: Apr 2009to Apr 2011
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Women aged >= 18 years at the time that the cervical specimen was taken, and diagnosed with invasive cervical cancer stage IB or greater

Who may be able to join

A female aged 18 years and above at the time of cervical specimen collection, and currently residing in New Zealand.
Histological diagnoses of invasive cervical cancer stage IB or greater, within at least the last 3 years.
Written informed consent obtained from the subject/ next of kin/ Legally acceptable representative.
Availability of cervical specimen on which the diagnosis was made prior to any chemotherapy or radiotherapy.
The cervical specimen should be of appropriate size and with regular tissue specimens.
The cervical specimen should be adequately preserved.
All links to the subject's identity should be removed from the paraffin block.

Who cannot join

Not Applicable.

About this study

Official title: Hospital-based Epidemiological Study on the Distribution of Human Papillomavirus (HPV) Types in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) in New Zealand

The aim of this study is to assess the distribution of the most frequent types of human papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.

Conditions: Cervical Cancer
Being tested: Testing of archived cervical cancer tissue samples, Data collection
Keywords: Invasive cervical cancer, Human papillomavirus
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testing of archived cervical cancer tissue samplesOther
Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.
Data collectionOther
Log sheet

Study groups in NCT01328028
Study group	Role	What they receive
Group A		Subjects diagnosed with invasive cervical cancer Receives: Other: Testing of archived 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 HPV-16 and HPV-18 in women with invasive cervical cancer
Measured: At least the last 3 years from the time of study start

Secondary outcomes (3)

Occurrence of other high-risk HPV types in women with invasive cervical cancer
Measured: At least the last 3 years from the time of study start
Occurrence of HPV-16/ HPV-18 co-infection with other high-risk HPV types in women with invasive cervical cancer
Measured: At least the last 3 years from the time of study start
Occurrence of low-risk HPV types in women diagnosed with invasive cervical cancer
Measured: At least the last 3 years from the time of study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Apr 2011

First posted4 Apr 2011 (estimated)
Study startApr 2009
Primary completionApr 2011
Study completionApr 2011

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 Cervical CancerStudies 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: Retrospective
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01328028
Sponsor's protocol ID: 111050
Status last verified: Jun 2011
First submitted: 31 Mar 2011
Last updated: 27 Aug 2012
Results posted: No

Publications

Sykes P, Gopala K, Tan AL, Kenwright D, Petrich S, Molijn A, Chen J. Type distribution of human papillomavirus among adult women diagnosed with invasive cervical cancer (stage 1b or higher) in New Zealand. BMC Infect Dis. 2014 Jul 8;14:374. doi: 10.1186/1471-2334-14-374.
PubMed 25000939

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
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RecruitingPhase 2/3
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RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hospital-based Epidemiological Study on the Distribution of Human Papillomavirus (HPV) Types in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) in New Zealand
ClinicalTrials.gov ID: NCT01328028
Acronym / sponsor ID: 111050
Conditions: Cervical Cancer
Keywords: Invasive cervical cancer, Human papillomavirus
Study type: Observational
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 4 Apr 2011 (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 this study is to assess the distribution of the most frequent types of human papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Group A	–	Other: Testing of archived cervical cancer tissue samples, Other: Data collectionSubjects diagnosed with invasive cervical cancer

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Women aged >= 18 years at the time that the cervical specimen was taken, and diagnosed with invasive cervical cancer stage IB or greater

Key inclusion criteria (7 listed)

A female aged 18 years and above at the time of cervical specimen collection, and currently residing in New Zealand.
Histological diagnoses of invasive cervical cancer stage IB or greater, within at least the last 3 years.
Written informed consent obtained from the subject/ next of kin/ Legally acceptable representative.
Availability of cervical specimen on which the diagnosis was made prior to any chemotherapy or radiotherapy.
The cervical specimen should be of appropriate size and with regular tissue specimens.

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
Testing of archived cervical cancer tissue samplesCervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.	Other	Group A
Data collectionLog sheet	Other	Group A

Primary outcome

Occurrence of HPV-16 and HPV-18 in women with invasive cervical cancer
Time frame: At least the last 3 years from the time of study start

3 secondary outcomes

Occurrence of other high-risk HPV types in women with invasive cervical cancer
Time frame: At least the last 3 years from the time of study start
Occurrence of HPV-16/ HPV-18 co-infection with other high-risk HPV types in women with invasive cervical cancer
Time frame: At least the last 3 years from the time of study start
Occurrence of low-risk HPV types in women diagnosed with invasive cervical cancer
Time frame: At least the last 3 years from the time of study start

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 27 Aug 2012.
Derived from this study: PubMed 25000939Sykes P, Gopala K, Tan AL, Kenwright D, Petrich S, Molijn A, Chen J. Type distribution of human papillomavirus among adult women diagnosed with invasive cervical cancer (stage 1b or higher) in New Zealand. BMC Infect Dis. 2014 Jul 8;14:374. doi: 10.1186/1471-2334-14-374.

Related trials for Cervical Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

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 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 7 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 27 Aug 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?

Occurrence of HPV-16 and HPV-18 in women with invasive cervical cancer (time frame: At least the last 3 years from the time of study start). 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 NCT01328028, 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 27 Aug 2012.