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

NCT01328028 | Completed

• 1 other identifier: 111050
• Study Type: observational
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cervical Cancer

Keywords

Invasive cervical cancer; Human papillomavirus

Outcome Measures

Primary Outcomes (1)

• Occurrence of HPV-16 and HPV-18 in women with invasive cervical cancer

  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

  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

  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

  At least the last 3 years from the time of study start

Study Arms (1)

Group A

Subjects diagnosed with invasive cervical cancer

Other: Testing of archived cervical cancer tissue samples; Other: Data collection

Interventions

Testing of archived cervical cancer tissue samples OTHER

Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.

Group A

Data collection OTHER

Log sheet

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• Not Applicable.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 25000939 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Cervical specimen

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 4, 2011
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 27, 2012

Record last verified: 2011-06