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TerminatedNCT00629577SAGEUpdated Feb 1, 2017

Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples

A Phase 1 interventional study of microarray analysis and flow cytometry in Cervical Cancer and Precancerous Condition, sponsored by British Columbia Cancer Agency. Terminated at 1 site in Canada. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-02-01.

Sponsored by British Columbia Cancer Agency · Phase 1, Interventional, and Diagnostic

Why this study was terminated
no funding
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
19 Years and older
Sex
Female
01

Study summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial is studying gene expression profiling of cervical cancer progression in biopsies and tissue samples from patients with cervical lesions.

Read the detailed description

OBJECTIVES:

  • Classify cervical cancer progression at a molecular level using gene expression profiling generated from expression microarrays.
  • Profile gene expression changes of dysplasia and early carcinoma of uterine cervical tissue at a molecular level using expression microarrays.
  • Define a set of genes that classify the various grades of cervical cancer/dysplasia at a molecular level.
  • Compare the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment.

OUTLINE: Patients undergo colposcopy and a cervical smear is taken for flow cytometry analysis. Patients also undergo 2 biopsies from one clinically abnormal or normal site. Tissue samples are analyzed by gene expression profiling using human expression microarrays containing approximately 40,000 unique sequences. Data analysis consists of defining a set of genes, containing new targets for biomarkers, that classify the biopsies into 3 grades.

02

Conditions studied

  • Cervical Cancer
  • Precancerous Condition

Keywords

  • cervical cancer
  • cervical intraepithelial neoplasia grade 1
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

DISEASE CHARACTERISTICS:

  • Clinically suspicious malignant or premalignant cervical lesion

Criteria

Inclusion criteria

Inclusion criteria:

  • Included subjects will be ≥18 years old.
  • Included subjects will not be pregnant.
  • Included subjects will have a negative urine pregnancy test.
  • Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
  • Included subjects will indicate understanding of the study.
  • Included subjects will provide informed consent to participate.

Exclusion criteria

Exclusion criteria:

  • Individuals \<18 years old will be excluded.
  • Pregnant individuals will be excluded.
  • Individuals that have had an operation to remove their cervix will be excluded.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • Geneticmicroarray analysis
  • Otherflow cytometry
  • Procedurebiopsy
  • Procedurecolposcopy
06

What researchers measure

Primary outcomes

  1. Classification of cervical cancer progression at a molecular level using gene expression profiling

  2. Gene expression changes by microarray

  3. Set of genes that classify the various grades of cervical cancer/dysplasia

  4. Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment

07

Study locations

1 site
  • BC Cancer Research Centre
    Vancouver, British Columbia V5Z 1L3, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00629577
Lead sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 6, 2008
Start date
Sep 2006
Primary completion
Jun 2010
Completion
Dec 2011
Last update
Feb 1, 2017

Study contacts

Thomas G Ehlen, M.D.
principal investigator · BC Cancer Agency, Vancouver General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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