Cervical CancerNCT00458562
Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer
An observational study of Cervical Cancer and Precancerous Condition, run by University of Washington at 2 sites in Senegal.
Trial summary
RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Precancerous Condition
- How many people
- 1,680 participants
- Where
- 2 sitesSenegal
- Study dates
- Jan 2006to Nov 2012
- 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: All study participants will be African women presenting to the clinical sites in Dakar, Senegal. Subjects will be representative of ethnic and racial groups living in Senegal.
Who may be able to join
- Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:
- Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following criteria:
- CIN grade 2-3 or higher
- Repeated CIN1 (times 6)
- Abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS] or worse)
- HIV seropositive
Show all 13Show fewer
- Negative cytology but positive for high-risk human papillomavirus (HPV)
- Negative cytology and negative HPV
- HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)
- >= 18 years of age
- Intact cervix
- Not pregnant
- Able to provide informed consent
Who cannot join
- < 18 years of age
- Pregnant at screening
- Cervix not intact
- not able to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Senegal2 sites
Centre Hospitalier Universite De Fann
Dakar, BP 5035
Hopital Aristide Le Dantec
Dakar, BP 5126
About this study
Official title: HIV-Associated DNA Hypermethylation in Cervical Cancer
RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future.
PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.
Read the detailed description
OBJECTIVES:
- Utilize molecular assays to identify a panel of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer (ICC) among patients with or without HIV infection.
- Perform a nested case-control study assessing the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes in these patients.
- Identify HIV-related factors (e.g., CD4 counts, viral load, and highly active antiretroviral therapy [HAART]) that might be associated with the presence or acquisition of specific hypermethylated genes in these patients.
OUTLINE: This is a longitudinal, multicenter study.
Patients undergo biopsy for removal of cervical tissue. Patients also undergo blood and urine sample collection. Samples are analyzed for the presence of cancer or changes that indicate that cancer might develop. Patients also undergo colposcopy at baseline and at 3 years.
After completion of study procedures, patients are followed every 4 months for up to 3 years.
PROJECTED ACCRUAL: A total of 1,150 patients will be accrued for this study.
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- cervical cancer, atypical squamous cells of undetermined significance, 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, Atypical Squamous Cells of the Cervix, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV+, <CIN2 | HIV positive women without CIN2-3 or worse | |
| HIV-, no >=CIN3 biopsy, HR HPV+ | HIV negative women without biopsy-proven CIN3 or worse, and with high risk HPV infection | |
| HIV-, <=CIN1, HPV- at screening | HIV negative women who are <= CIN1 and HPV negative at screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer
Use molecular assays to identify a panel of hypermethylated genes that are predictive of CIN-3/ICC among women with and without HIV infection. We will rank genes by their ability to discriminate normal cervical tissue from CIN-3/ICC after stratifying by HIV infection.
Measured: 3 years
Assessment of the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes
Perform a nested case control study assessing the risk of developing CIN-3 in relationship to HPV persistence, HIV, and the presence or acquisition of the candidate hypermethylated genes.
Measured: 3 years
Identification of HIV-related factors associated with the presence or acquisition of specific hypermethylated genes
Identify HIV-related factors (CD4 counts, viral load, HAART) which might be associated with the presence or acquisition of specific hypermethylated genes.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startJan 2006
- Primary completionNov 2012
- Study completionNov 2012
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 University of WashingtonThe 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-control
- Time perspective
- Prospective
- Enrolment
- 1,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nancy B. Kiviat, MD, Principal investigator, Harborview Injury Prevention and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458562
- Sponsor's protocol ID
- 6113
- Other IDs
- R01CA111187, P30CA015704, UWCC-6113, UWCC-04-4928-B01, FHCRC-6113, CDR0000482330
- Status last verified
- Nov 2013
- First submitted
- 9 Apr 2007
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-Associated DNA Hypermethylation in Cervical Cancer
- ClinicalTrials.gov ID
- NCT00458562
- Acronym / sponsor ID
- 6113
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- cervical cancer, atypical squamous cells of undetermined significance, 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
- 1,680 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Apr 2007 (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: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future.
PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.
Detailed description
OBJECTIVES:
- Utilize molecular assays to identify a panel of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer (ICC) among patients with or without HIV infection.
- Perform a nested case-control study assessing the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes in these patients.
- Identify HIV-related factors (e.g., CD4 counts, viral load, and highly active antiretroviral therapy [HAART]) that might be associated with the presence or acquisition of specific hypermethylated genes in these patients.
OUTLINE: This is a longitudinal, multicenter study.
Patients undergo biopsy for removal of cervical tissue. Patients also undergo blood and urine sample collection. Samples are analyzed for the presence of cancer or changes that indicate that cancer might develop. Patients also undergo colposcopy at baseline and at 3 years.
After completion of study procedures, patients are followed every 4 months for up to 3 years.
PROJECTED ACCRUAL: A total of 1,150 patients will be accrued for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV+, <CIN2 | – | –HIV positive women without CIN2-3 or worse |
| HIV-, no >=CIN3 biopsy, HR HPV+ | – | –HIV negative women without biopsy-proven CIN3 or worse, and with high risk HPV infection |
| HIV-, <=CIN1, HPV- at screening | – | –HIV negative women who are <= CIN1 and HPV negative at screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants will be African women presenting to the clinical sites in Dakar, Senegal. Subjects will be representative of ethnic and racial groups living in Senegal.
Key inclusion criteria (13 listed)
- Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:
- >= 18 years of age
- Intact cervix
- Not pregnant
- Able to provide informed consent
Key exclusion criteria (4 listed)
- < 18 years of age
- Pregnant at screening
- Cervix not intact
- not able to provide informed consent
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
Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer
Time frame: 3 years
Use molecular assays to identify a panel of hypermethylated genes that are predictive of CIN-3/ICC among women with and without HIV infection. We will rank genes by their ability to discriminate normal cervical tissue from CIN-3/ICC after stratifying by HIV infection.
Assessment of the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes
Time frame: 3 years
Perform a nested case control study assessing the risk of developing CIN-3 in relationship to HPV persistence, HIV, and the presence or acquisition of the candidate hypermethylated genes.
Identification of HIV-related factors associated with the presence or acquisition of specific hypermethylated genes
Time frame: 3 years
Identify HIV-related factors (CD4 counts, viral load, HAART) which might be associated with the presence or acquisition of specific hypermethylated genes.
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 19 Nov 2013.
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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.
Nancy B. Kiviat, MD principal investigator
Harborview Injury Prevention and Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Precancerous Condition, run by University of Washington at 2 sites in Senegal.
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 13 inclusion and 4 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer (time frame: 3 years). The study lists 3 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 19 Nov 2013.