Anal CarcinomaNCT00867464
Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
An observational study of Anal Carcinoma and Cervical Carcinoma, run by National Cancer Institute (NCI) at 1 site in Costa Rica.
Trial summary
This research trial studies extended follow up of young women in Costa Rica who received vaccine for human papillomavirus types 16 and 18 and unvaccinated controls. Collecting information from young women in Costa Rica who have received vaccine for human papillomavirus types 16 and 18 and a new group of unvaccinated… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anal Carcinoma, Cervical Carcinoma, Human Papillomavirus Infection
- What is being tested?
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis and Long-term Follow-up
- How many people
- 8,670 participants
- Where
- 1 siteCosta Rica
- Study dates
- 30 Mar 2009to 23 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Young women in Costa Rica who received vaccination against human papillomavirus types 16 and 18 and unvaccinated controls.
Who may be able to join
- Women who participated in the Costa Rica Vaccine Trial (CVT) and lived in the Guanacaste province and a few areas of Puntarenas closest to Guanacaste will be eligible for the long-term follow up LTFU study
- Women who received the HPV-16/18 vaccine at the start of CVT will be invited for up to 6 years of additional follow-up, and women who were originally in the control arm of CVT and were offered the HPV-16/18 vaccine at crossover will be invited for an additional 2 years of follow-up
- A subset of the control arm women who are in the crossover immunogenicity subcohort will be followed the full 6 years
- Some women who received HPV vaccination and were not invited into the LTFU protocol (stopped attending their screening visits during CVT, discontinued their study participation during CVT or lived outside the study area) will be invited to participate in the LTFU protocol, particularly those who received an incomplete vaccination schedule
- UNVACCINATED CONTROL GROUP:
- Born in or between July 1978 and November 1987
Show all 10Show fewer
- Residents of Guanacaste Province and a few areas of Puntarenas closest to Guanacaste at some point during 2005
- Able to speak/understand Spanish
- Apparently mentally competent
- Written informed consent obtained prior to enrollment
Who cannot join
- History of cervical cancer
- History of hysterectomy
- Any important medical condition or other criteria that the investigator considers that precludes enrollment
- Vaccination with Gardasil or Cervarix will be an exclusionary criterion, but few women are expected to have received these vaccines at the time of enrollment; use of these vaccines after enrollment is not a criterion for study interruption but we plan to collect information on vaccination history so that the few women who report having been vaccinated with one of the HPV vaccines after enrollment can be evaluated separately at analysis
Trial locations and contacts
1 site in 1 country.
Costa Rica1 site
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia, Guanacaste Province, 50101
About this study
Official title: Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
This research trial studies extended follow up of young women in Costa Rica who received vaccine for human papillomavirus types 16 and 18 and unvaccinated controls. Collecting information from young women in Costa Rica who have received vaccine for human papillomavirus types 16 and 18 and a new group of unvaccinated controls enrolled for the follow-up period, may help doctors learn more about the risks and benefits of prophylactic human papillomavirus vaccine.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the 10-year global impact of human papillomavirus (HPV)-16/18 vaccination of young adult women.
II. To evaluate determinants of the immune response to HPV and the vaccine, and markers of long-term protection.
III. To evaluate the natural history of HPV and cervical disease in vaccinated and unvaccinated populations.
OUTLINE:
Participants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10.
- Conditions
- Anal Carcinoma, Cervical Carcinoma, Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma, Oral Cavity Carcinoma
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Long-term Follow-up, Questionnaire Administration
- Medical subject headings
- Anus Neoplasms, Uterine Cervical Neoplasms, Papillomavirus Infections, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Correlative studies
Laboratory Biomarker AnalysisOther
Correlative studies
Long-term Follow-upOther
Also called long term follow-up (clinical study), long-term follow-up (research), LTFU
Undergo extended follow-up
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (long term follow-up) | Participants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Long-term Follow-up; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of cervical intraepithelial neoplasia 3 (CIN3)
Both absolute rate differences and percent reduction in rates will be evaluated.
Measured: At 10 years
Level of immune response markers as prediction of long-term success of HPV vaccine
For efficiency, a nested case-control approach is envisioned to evaluate this question. We propose to compare women who become infected against a subset of those who do not (non-failures) with respect to immune response markers of interest.
Measured: Up to 10 years
Increase in the rate of cervical lesions associated with other carcinogenic HPV types that the vaccine does not protect against from prevention of HPV-16/18 associated cervical lesions through vaccination
The 10-year cumulative rate of incident CIN2+ associated with HPV types other than HPV-16/18 and closely related HPV types in the alpha-7/9 species for which evidence of vaccine cross-protection is demonstrated will be compared between vaccinated and unvaccinated women.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study start30 Mar 2009
- Primary completion23 Dec 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anal CarcinomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8,670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Aimee Kreimer, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867464
- Sponsor's protocol ID
- NCI-2016-00231
- Other IDs
- NCI-2016-00231, 999909106, 09-C-N106
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2009
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shing JZ, Hu S, Herrero R, Hildesheim A, Porras C, Sampson JN, Schussler J, Schiller JT, Lowy DR, Sierra MS, Carvajal L, Kreimer AR; Costa Rica HPV Vaccine Trial Group. Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial. Lancet Oncol. 2022 Jul;23(7):940-949. doi: 10.1016/S1470-2045(22)00291-1. Epub 2022 Jun 13.
PubMed 35709811Porras C, Tsang SH, Herrero R, Guillen D, Darragh TM, Stoler MH, Hildesheim A, Wagner S, Boland J, Lowy DR, Schiller JT, Schiffman M, Schussler J, Gail MH, Quint W, Ocampo R, Morales J, Rodriguez AC, Hu S, Sampson JN, Kreimer AR; Costa Rica Vaccine Trial Group. Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial. Lancet Oncol. 2020 Dec;21(12):1643-1652. doi: 10.1016/S1470-2045(20)30524-6.
PubMed 33271093
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls
- ClinicalTrials.gov ID
- NCT00867464
- Acronym / sponsor ID
- NCI-2016-00231
- Conditions
- Anal Carcinoma, Cervical Carcinoma, Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma, Oral Cavity Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,670 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 30 Mar 2009 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 23 Mar 2009 (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.
This research trial studies extended follow up of young women in Costa Rica who received vaccine for human papillomavirus types 16 and 18 and unvaccinated controls. Collecting information from young women in Costa Rica who have received vaccine for human papillomavirus types 16 and 18 and a new group of unvaccinated controls enrolled for the follow-up period, may help doctors learn more about the risks and benefits of prophylactic human papillomavirus vaccine.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the 10-year global impact of human papillomavirus (HPV)-16/18 vaccination of young adult women.
II. To evaluate determinants of the immune response to HPV and the vaccine, and markers of long-term protection.
III. To evaluate the natural history of HPV and cervical disease in vaccinated and unvaccinated populations.
OUTLINE:
Participants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (long term follow-up) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis, Other: Long-term Follow-up, Other: Questionnaire AdministrationParticipants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Young women in Costa Rica who received vaccination against human papillomavirus types 16 and 18 and unvaccinated controls.
Key inclusion criteria (10 listed)
- Women who participated in the Costa Rica Vaccine Trial (CVT) and lived in the Guanacaste province and a few areas of Puntarenas closest to Guanacaste will be eligible for the long-term follow up LTFU study
- Women who received the HPV-16/18 vaccine at the start of CVT will be invited for up to 6 years of additional follow-up, and women who were originally in the control arm of CVT and were offered the HPV-16/18 vaccine at crossover will be invited for an additional 2 years of follow-up
- A subset of the control arm women who are in the crossover immunogenicity subcohort will be followed the full 6 years
- Some women who received HPV vaccination and were not invited into the LTFU protocol (stopped attending their screening visits during CVT, discontinued their study participation during CVT or lived outside the study area) will be invited to participate in the LTFU protocol, particularly those who received an incomplete vaccination schedule
- UNVACCINATED CONTROL GROUP:
Key exclusion criteria (4 listed)
- History of cervical cancer
- History of hysterectomy
- Any important medical condition or other criteria that the investigator considers that precludes enrollment
- Vaccination with Gardasil or Cervarix will be an exclusionary criterion, but few women are expected to have received these vaccines at the time of enrollment; use of these vaccines after enrollment is not a criterion for study interruption but we plan to collect information on vaccination history so that the few women who report having been vaccinated with one of the HPV vaccines after enrollment can be evaluated separately at analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingCorrelative studies | Other | Observational (long term follow-up) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Observational (long term follow-up) |
| Long-term Follow-upAlso: long term follow-up (clinical study), long-term follow-up (research), LTFUUndergo extended follow-up | Other | Observational (long term follow-up) |
| Questionnaire AdministrationAncillary studies | Other | Observational (long term follow-up) |
Primary outcome
Cumulative rate of cervical intraepithelial neoplasia 3 (CIN3)
Time frame: At 10 years
Both absolute rate differences and percent reduction in rates will be evaluated.
Level of immune response markers as prediction of long-term success of HPV vaccine
Time frame: Up to 10 years
For efficiency, a nested case-control approach is envisioned to evaluate this question. We propose to compare women who become infected against a subset of those who do not (non-failures) with respect to immune response markers of interest.
Increase in the rate of cervical lesions associated with other carcinogenic HPV types that the vaccine does not protect against from prevention of HPV-16/18 associated cervical lesions through vaccination
Time frame: Up to 10 years
The 10-year cumulative rate of incident CIN2+ associated with HPV types other than HPV-16/18 and closely related HPV types in the alpha-7/9 species for which evidence of vaccine cross-protection is demonstrated will be compared between vaccinated and unvaccinated women.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Derived from this study: PubMed 35709811Shing JZ, Hu S, Herrero R, Hildesheim A, Porras C, Sampson JN, Schussler J, Schiller JT, Lowy DR, Sierra MS, Carvajal L, Kreimer AR; Costa Rica HPV Vaccine Trial Group. Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial. Lancet Oncol. 2022 Jul;23(7):940-949. doi: 10.1016/S1470-2045(22)00291-1. Epub 2022 Jun 13.
- Derived from this study: PubMed 33271093Porras C, Tsang SH, Herrero R, Guillen D, Darragh TM, Stoler MH, Hildesheim A, Wagner S, Boland J, Lowy DR, Schiller JT, Schiffman M, Schussler J, Gail MH, Quint W, Ocampo R, Morales J, Rodriguez AC, Hu S, Sampson JN, Kreimer AR; Costa Rica Vaccine Trial Group. Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial. Lancet Oncol. 2020 Dec;21(12):1643-1652. doi: 10.1016/S1470-2045(20)30524-6.
Related trials for Anal Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Anal Cancer
Active, not recruitingPhase 2
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous Cell Carcinoma of the Anus Stage III
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
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.
Aimee Kreimer 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 Anal Carcinoma and Cervical Carcinoma, 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 10 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cumulative rate of cervical intraepithelial neoplasia 3 (CIN3) (time frame: At 10 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?
On the ClinicalTrials.gov record for NCT00867464, which also lists 2 linked publications.
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 28 Aug 2026.