Cervical NeoplasiaNCT00342173
Costa Rican Natural History Study of HPV and Cervical Neoplasia
An observational study of Cervical Neoplasia, run by National Cancer Institute (NCI) at 1 site in Costa Rica.
Trial summary
A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Cervical Neoplasia
- How many people
- 11,545 participants
- Where
- 1 siteCosta Rica
- Study dates
- 20 May 1999to 12 Mar 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. Three distinct groups of women of approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The first group consists of women who at enrollment had evidence of low-grade cervical lesions (LSIL) or equivocal lesions and a sample of the remaining cohort members. The second group consists of women who were cytologically normal at enrollment but randomly selected for active follow-up. The final group consists of the remaining women in our cohort (all cytologyically normal at enrollment).
Who may be able to join
- Must be between the ages of 45 to 70 years.
- Women who do not have a final diagnosis of HSIL.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. At the initial recruitment visit, all women were administered a brief risk factor questionnaire, had 15ml of blood collected and, if sexually active, were given a pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were additional cervical cells which were then used for additional monolayer smears (ThinPrep) and for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were also taken as a third screening test. Based on these screening tests, women were referred to colposcopy, at which time a more detailed risk factor questionnaire was administered, additional cervical cells and blood (15ml) were collected, and histological specimens were obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion (HSIL) or cervical cancer were treated by Social Security Administration clinicians using standard local protocols.
Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who have been followed as part of our longitudinal study. Three distinct groups of women of approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The first group consists of women who at enrollment had evidence of low-grade cervical lesions (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group is being followed actively at 6-12 month intervals through their seventh anniversary in the cohort. The second group consists of women who were cytologically normal at enrollment but randomly selected for active follow-up. This second group will be seen once after enrollment, at their fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth anniversary visit will be added to the first group described above and followed at 6-month intervals. The final group consists of the remaining women in our cohort (all cytologically normal at enrollment). These women are being followed passively via linkage to the cytology and tumor registries in Cost Rica.
Read more
Clinical visits conducted during follow-up consist of a brief personal interview that collects information on exposures since enrollment, the collection of 15ml blood, and a pelvic examination. Pap smear is prepared during the pelvic examination, and additional cervical specimens are collected and used to prepare a monolayer smear (ThinPrep) and for human papillomavirus and other testing. Similar to the enrollment visit, cervigrams are also collected from each participant at the time of their follow-up visits.
During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear, ThinPrep, cervicography, or by visual inspection) are referred to colposcopy, censored from the study, and treated by Social Security Administration clinicians using standard local protocols.
Read the detailed description
A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. At the initial recruitment visit, all women were administered a brief risk factor questionnaire, had 15ml of blood collected and, if sexually active, were given a pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were additional cervical cells which were then used for additional monolayer smears (ThinPrep) and for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were also taken as a third screening test. Based on these screening tests, women were referred to colposcopy, at which time a more detailed risk factor questionnaire was administered, additional cervical cells and blood (15ml) were collected, and histological specimens were obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion (HSIL) or cervical cancers were treated by Social Security Administration clinicians using standard local protocols.
Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who were followed as part of our longitudinal study. Three distinct groups of women of approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The first group consists of women who at enrollment had evidence of low-grade cervical lesions (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group was followed actively at 6-12 month intervals through their seventh anniversary in the cohort. The second group consists of women who were cytologically normal at enrollment but randomly selected for active follow-up. This second group was seen once after enrollment, close to fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth anniversary visit were added to the first group described above and followed at 6-month intervals. The final group consists of the remaining women in our cohort (all cytologically normal at enrollment). These women were followed passively via linkage to the cytology and tumor registries in Costa Rica.
Clinical visits conducted during follow-up consisted of a brief personal interview that collects information on exposures since enrollment, the collection of 15ml blood, and a pelvic examination. A Pap smear was prepared during the pelvic examination, and additional cervical specimens were collected and used to prepare a monolayer smear (ThinPrep) and for human papillomavirus and other testing. Similar to the enrollment visit, cervigrams were also collected from each participant at the time of their follow-up visits.
During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear, ThinPrep, cervicography, or by visual inspection) were referred to colposcopy, censored from the study, and treated by Social Security Administration clinicians using standard local protocols.
- Conditions
- Cervical Neoplasia
- Keywords
- Cervix, Natural History, Neoplasia, HPV, Costa Rica
- Medical subject headings
- Neoplasms
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 |
|---|---|---|
| Women in Costa Rica | Examining the natural history of HPV and cervical neoplasia in Costa Rican women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural History of human papillomaviruses (HPV) and cervical neoplasia
Cervical precancer and cancer
Measured: 7-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start20 May 1999
- Primary completion12 Mar 2012
- Study completion12 Mar 2012
Why it stopped: classified by the IRB as non human subjects research
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 NeoplasiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,545 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark H Schiffman, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342173
- Sponsor's protocol ID
- 999999030
- Other IDs
- OH99-C-N030
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2006
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Campos NG, Burger EA, Sy S, Sharma M, Schiffman M, Rodriguez AC, Hildesheim A, Herrero R, Kim JJ. An updated natural history model of cervical cancer: derivation of model parameters. Am J Epidemiol. 2014 Sep 1;180(5):545-55. doi: 10.1093/aje/kwu159. Epub 2014 Jul 31.
PubMed 25081182
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costa Rican Natural History Study of HPV and Cervical Neoplasia
- ClinicalTrials.gov ID
- NCT00342173
- Acronym / sponsor ID
- 999999030
- Conditions
- Cervical Neoplasia
- Keywords
- Cervix, Natural History, Neoplasia, HPV, Costa Rica
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: classified by the IRB as non human subjects research
- Enrolment
- 11,545 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 20 May 1999 (actual)
- Primary completion
- 12 Mar 2012 (actual)
- Study completion
- 12 Mar 2012 (actual)
- First posted
- 21 Jun 2006 (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.
A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. At the initial recruitment visit, all women were administered a brief risk factor questionnaire, had 15ml of blood collected and, if sexually active, were given a pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were additional cervical cells which were then used for additional monolayer smears (ThinPrep) and for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were also taken as a third screening test. Based on these screening tests, women were referred to colposcopy, at which time a more detailed risk factor questionnaire was administered, additional cervical cells and blood (15ml) were collected, and histological specimens were obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion (HSIL) or cervical cancer were treated by Social Security Administration clinicians using standard local protocols.
Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who have been followed as part of our longitudinal study. Three distinct groups of women of approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The first group consists of women who at enrollment had evidence of low-grade cervical lesions (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group is being followed actively at 6-12 month intervals through their seventh anniversary in the cohort. The second group consists of women who were cytologically normal at enrollment but randomly selected for active follow-up. This second group will be seen once after enrollment, at their fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth anniversary visit will be added to the first group described above and followed at 6-month intervals. The final group consists of the remaining women in our cohort (all cytologically normal at enrollment). These women are being followed passively via linkage to the cytology and tumor registries in Cost Rica.
Clinical visits conducted during follow-up consist of a brief personal interview that collects information on exposures since enrollment, the collection of 15ml blood, and a pelvic examination. Pap smear is prepared during the pelvic examination, and additional cervical specimens are collected and used to prepare a monolayer smear (ThinPrep) and for human papillomavirus and other testing. Similar to the enrollment visit, cervigrams are also collected from each participant at the time of their follow-up visits.
During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear, ThinPrep, cervicography, or by visual inspection) are referred to colposcopy, censored from the study, and treated by Social Security Administration clinicians using standard local protocols.
Detailed description
A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. At the initial recruitment visit, all women were administered a brief risk factor questionnaire, had 15ml of blood collected and, if sexually active, were given a pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were additional cervical cells which were then used for additional monolayer smears (ThinPrep) and for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were also taken as a third screening test. Based on these screening tests, women were referred to colposcopy, at which time a more detailed risk factor questionnaire was administered, additional cervical cells and blood (15ml) were collected, and histological specimens were obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion (HSIL) or cervical cancers were treated by Social Security Administration clinicians using standard local protocols.
Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who were followed as part of our longitudinal study. Three distinct groups of women of approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The first group consists of women who at enrollment had evidence of low-grade cervical lesions (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group was followed actively at 6-12 month intervals through their seventh anniversary in the cohort. The second group consists of women who were cytologically normal at enrollment but randomly selected for active follow-up. This second group was seen once after enrollment, close to fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth anniversary visit were added to the first group described above and followed at 6-month intervals. The final group consists of the remaining women in our cohort (all cytologically normal at enrollment). These women were followed passively via linkage to the cytology and tumor registries in Costa Rica.
Clinical visits conducted during follow-up consisted of a brief personal interview that collects information on exposures since enrollment, the collection of 15ml blood, and a pelvic examination. A Pap smear was prepared during the pelvic examination, and additional cervical specimens were collected and used to prepare a monolayer smear (ThinPrep) and for human papillomavirus and other testing. Similar to the enrollment visit, cervigrams were also collected from each participant at the time of their follow-up visits.
During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear, ThinPrep, cervicography, or by visual inspection) were referred to colposcopy, censored from the study, and treated by Social Security Administration clinicians using standard local protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women in Costa Rica | – | –Examining the natural history of HPV and cervical neoplasia in Costa Rican women. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. Three distinct groups of women of approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The first group consists of women who at enrollment had evidence of low-grade cervical lesions (LSIL) or equivocal lesions and a sample of the remaining cohort members. The second group consists of women who were cytologically normal at enrollment but randomly selected for active follow-up. The final group consists of the remaining women in our cohort (all cytologyically normal at enrollment).
Key inclusion criteria (2 listed)
- Must be between the ages of 45 to 70 years.
- Women who do not have a final diagnosis of HSIL.
Key exclusion criteria (0 listed)
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
Natural History of human papillomaviruses (HPV) and cervical neoplasia
Time frame: 7-year follow-up
Cervical precancer and cancer
Results and safety
The study was stopped early (reason given: classified by the IRB as non human subjects research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 25081182Campos NG, Burger EA, Sy S, Sharma M, Schiffman M, Rodriguez AC, Hildesheim A, Herrero R, Kim JJ. An updated natural history model of cervical cancer: derivation of model parameters. Am J Epidemiol. 2014 Sep 1;180(5):545-55. doi: 10.1093/aje/kwu159. Epub 2014 Jul 31.
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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.
Mark H Schiffman, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Neoplasia, run by National Cancer Institute (NCI) at 1 site in Costa Rica.
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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Costa Rica. 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 was stopped early (reason given: classified by the IRB as non human subjects research). Results are not available in the source record.
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?
Natural History of human papillomaviruses (HPV) and cervical neoplasia (time frame: 7-year follow-up). 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 NCT00342173, 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 16 Mar 2020.