Cervical CancerNCT00601601
Identifying Biomarkers for Early Detection of Cancer in Patients With Cervical Dysplasia or Carcinoma in Situ of the Cervix
An observational study of Cervical Cancer and Precancerous Condition, run by British Columbia Cancer Agency.
Trial summary
RATIONALE: Studying the genes expressed in samples of tissue from patients with abnormal cells may help doctors identify biomarkers related to cancer. PURPOSE: This clinical trial is identifying biomarkers for early detection of cancer in women with cervical dysplasia or carcinoma in situ of the cervix. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Cervical Cancer, Precancerous Condition
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to May 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients attending Vancouver General Hospital and referred to colposcopy for loop electrocautery excision procedure (LEEP).
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed premalignant lesion, dysplasia, or carcinoma in situ of the cervix
- Clinically documented disease
- Attending Vancouver General Hospital and referred to colposcopy for loop electrocautery excision procedure (LEEP)
PATIENT CHARACTERISTICS:
- Not pregnant
- No lack of informed consent due to language difficulty, physical and mental condition
PRIOR CONCURRENT THERAPY:
- No prior operation for removal of the cervix
- Concurrent therapy allowed
About this study
Official title: Genomics Approach to Id Novel Targets & Markers for Early Detection And Intervention In Cancer (Cervical)
RATIONALE: Studying the genes expressed in samples of tissue from patients with abnormal cells may help doctors identify biomarkers related to cancer.
PURPOSE: This clinical trial is identifying biomarkers for early detection of cancer in women with cervical dysplasia or carcinoma in situ of the cervix.
Read the detailed description
OBJECTIVES:
Primary
- To identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer.
- To identify a ranked list of candidate genes that drive the transformation of premalignant lesions to tumors for further study and validation as molecular targets for novel early detection and treatment design.
Secondary
- To complete genome scans at high density and analysis of gene and protein expression to identify recurrent genetic and protein changes in cancer.
- To confirm changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes.
OUTLINE: Patients undergo biopsy of cervical tissue followed by loop electrocautery excision procedure (LEEP) (removing all of the tissue surrounding and under the area biopsied). RNA, DNA, and protein is extracted from the cells to provide material for the construction of libraries for Serial Analysis of Gene Expression (SAGE analysis); for hybridization against Bacterial Artificial Chromosome Comparative Genome Hybridization arrays (BAC CGH arrays); and for analysis using protein chip arrays and proteomics. Resulting data from coded samples provide gene expression and protein profiles. The coded molecular datasets are linked, analyzed, and compared using a variety of statistical software to identify putative genes, gene alterations, and proteins of interest. Some samples may be banked for future studies.
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- stage 0 cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
- Medical subject headings
- Uterine Cervical Neoplasms, Precancerous Conditions, Uterine Cervical Dysplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer
Measured: Done at the completion of the study.
Identify a ranked list of candidate genes that drive the transformation of premalignant lesions to tumors for further study and validation as molecular targets for novel early detection and treatment design
Measured: Done at the completion of the study.
Completion of genome scans at high density and analysis of gene and protein expressions to identify recurrent genetic and protein changes in cancer
Measured: Done at the completion of the study.
Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes
Measured: Done at the completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startDec 2004
- Primary completionApr 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sylvia Lam, Study chair, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601601
- Sponsor's protocol ID
- CDR0000581302
- Other IDs
- R01CA103830, BCCR-H04-60112, BCCR-RO4-0112
- Status last verified
- Mar 2012
- First submitted
- 25 Jan 2008
- Last updated
- 9 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics Approach to Id Novel Targets & Markers for Early Detection And Intervention In Cancer (Cervical)
- ClinicalTrials.gov ID
- NCT00601601
- Acronym / sponsor ID
- CDR0000581302
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- stage 0 cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Jan 2008 (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.
RATIONALE: Studying the genes expressed in samples of tissue from patients with abnormal cells may help doctors identify biomarkers related to cancer.
PURPOSE: This clinical trial is identifying biomarkers for early detection of cancer in women with cervical dysplasia or carcinoma in situ of the cervix.
Detailed description
OBJECTIVES:
Primary
- To identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer.
- To identify a ranked list of candidate genes that drive the transformation of premalignant lesions to tumors for further study and validation as molecular targets for novel early detection and treatment design.
Secondary
- To complete genome scans at high density and analysis of gene and protein expression to identify recurrent genetic and protein changes in cancer.
- To confirm changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes.
OUTLINE: Patients undergo biopsy of cervical tissue followed by loop electrocautery excision procedure (LEEP) (removing all of the tissue surrounding and under the area biopsied). RNA, DNA, and protein is extracted from the cells to provide material for the construction of libraries for Serial Analysis of Gene Expression (SAGE analysis); for hybridization against Bacterial Artificial Chromosome Comparative Genome Hybridization arrays (BAC CGH arrays); and for analysis using protein chip arrays and proteomics. Resulting data from coded samples provide gene expression and protein profiles. The coded molecular datasets are linked, analyzed, and compared using a variety of statistical software to identify putative genes, gene alterations, and proteins of interest. Some samples may be banked for future studies.
Study design
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients attending Vancouver General Hospital and referred to colposcopy for loop electrocautery excision procedure (LEEP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer
Time frame: Done at the completion of the study.
Identify a ranked list of candidate genes that drive the transformation of premalignant lesions to tumors for further study and validation as molecular targets for novel early detection and treatment design
Time frame: Done at the completion of the study.
Completion of genome scans at high density and analysis of gene and protein expressions to identify recurrent genetic and protein changes in cancer
Time frame: Done at the completion of the study.
Changes clustered to specific chromosomal regions which harbor tumor suppressors or oncogenes
Time frame: Done at the completion of the study.
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 9 Mar 2012.
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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.
Sylvia Lam study chair
British Columbia Cancer Agency
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Precancerous Condition, run by British Columbia Cancer Agency.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Mar 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?
Identify and catalogue genetic alterations and protein changes associated with developmental stages of cervical cancer (time frame: Done at the completion of the study.). The study lists 4 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 9 Mar 2012.