CIN3ESTAMPANCT01881659
Cervical Cancer Screening With Human Papillomavirus Testing
An observational study of CIN3 and CIN2, run by International Agency for Research on Cancer at 12 sites in 9 countries.
Trial summary
HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension… Read more about this study
- Who is it for?
- Ages 30 to 64 years, women only
- Conditions the study is for
- CIN3, CIN2, Cervical Cancer
- What is being tested?
- HPV screening
- How many people
- 50,000 participants
- Where
- 12 sitesin 9 countries
- Study dates
- May 2013to 31 Dec 2023
- 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 30 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: This is a multicentric study to be carried out in countries across the Latin American region. At each site, a census of all women 28-64 years of age residents of the selected area will be done previously to the start of the study. All women will then be invited using different approaches to the local health centers where screening is to happen.
Who may be able to join
- Aged 30-64 years
- Mentally competent to be able to understand the consent form
- Able to communicate with study staff
- Physically able to have a pelvic exam
Who cannot join
- Reporting no previous sexual activity
- History of cervical cancer
- Previous treatment for cervical pre-cancer in the last six months
- Hysterectomy
- Plans to move out of the study area in the next 12 months
- Screened for cervical cancer in the last 12 months (depending on local regulations)
Trial locations and contacts
12 sites in 9 countries.
12 sites in 9 countries
Argentina2 sites
Hopsital de Clinicas
Buenos Aires
Insituto Malbran - Hospital Posadas
Buenos Aires
Colombia2 sites
National Cancer Institute of Colombia
Bogotá
Universidad de Antioquia
Medellín
Paraguay2 sites
Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asuncion
Asunción
Laboratorio Central de Salud Publica
Asunción
About this study
Official title: Multicentric Study of Cervical Cancer Screening and Triage With Human Papillomavirus (HPV) Testing
HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension of screening intervals. However, a single HPV test has low positive predictive value and can lead to unnecessary workup and over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000 women with HPV testing and compare several triage approaches that can follow HPV testing in order to make an HPV-based screening programme efficient, affordable and sustainable.
Read the detailed description
The study will be conducted in several Latin American countries. Currently, the study has started in one site in Colombia and soon another site in Mexico will start. In each participating center, women aged 30-64 years who are attending clinics for cervical screening will be invited to participate in the study. Women who agree to participate and sign the corresponding Institutional Review Board (IRB) approved consent forms will undergo a pelvic examination, and cervical cells for primary screening and triage will be collected. Recruitment specimens will be used for primary screening with an established HPV DNA test (Food and Drug Administration FDA approved). All women who are HPV-positive by the recruitment test will be referred for a standardized colposcopy examination for diagnosis. At the colposcopy visit, but before colposcopy is performed, a risk factor interview will be administered and participants will undergo visual inspection of the cervix with acetic acid (VIA) and collection of additional cervical cells and a blood specimen. The results of VIA will not be disclosed to the colposcopist. During colposcopy, the colposcopists will obtain (2-4) biopsies from any abnormally-appearing areas to ascertain neoplastic outcomes (CIN3+) and to direct treatment as required. All women who attend colposcopy will have a second round of HPV testing approximately 18 months after recruitment and those who are HPV-positive will be referred to colposcopy for final diagnosis. Data management and study supervision will be the responsibility of the International Agency for Research on Cancer (IARC) and the local Principal Investigators, most of whom are experienced HPV researchers.
The combined number of histologically-confirmed diagnoses of CIN3+, including CIN2 lesions positive for p16, (estimated n=500) will be the outcome of primary interest for evaluation of the performance of the various triage modalities. Our initial analyses will focus on comparisons of triage strategies that employ a single method: VIA, conventional/liquid-based cytology, HPV DNA genotyping, HPV RNA detection, detection of E6 proteins of high risk HPV types, or markers of HPV-induced cell-cycle alterations (e.g., p16, ki67, etc). To the extent possible, molecular testing for HPV triage will be carried out on the recruitment specimens to simulate a 'reflex testing' approach wherein screening and triage are done on the same specimen without additional visits. Subsequent analyses will consider various alternative strategies that employ more than one triage methodology; e.g., HPV DNA genotyping followed by cytology. The effectiveness and costs of each alternative strategy will be assessed under various scenarios of feasibility, cost, and effectiveness.
- Conditions
- CIN3, CIN2, Cervical Cancer
- Being tested
- HPV screening
- Keywords
- cervical cancer, cancer prevention, cervical screening, HPV testing, triage techniques
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV screeningOther
Women who signed informed consent will be screened with HPV testing.
| Study group | Role | What they receive |
|---|---|---|
| Women attending cervical screening | Women aged 30-64 years who signed informed consent and comply with inclusion and exclusion criteria. Receives: Other: HPV screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with histologically confirmed cervical intraepithelial neoplasia grade 3 or cancer (CIN3+), including CIN2 positive for p16, on reviewed histology
There will be two HPV screening rounds. Women who test negative for HPV at initial screening will finish their participation. HPV positive women will be: 1) referred to colposcopy, 2) invited for a second HPV screening round if not yet treated, and 3) referred to final colposcopy if HPV positive at second screening. Clinical management will be based on local histology.
Histology specimens will be externally reviewed by one highly experience international pathologist. If the local and external results are the same, this will become the final histology. If there is disagreement, the specimen will be sent to a third pathologist (be blinded to previous readings). The final diagnosis will then be that agreed by two pathologists (local and either external or both external). Remaining discrepancies will be solved by adjudication at a multi-headed microscope. Worst histology on review will be used to define outcome measures.
Measured: Detected after initial HPV screening or at second screening round 18 months since entry
Secondary outcomes (1)
Number of participants with histologically confirmed CIN2, CIN3 or cancer (CIN2+) on reviewed histology
There will be two HPV screening rounds. Women who test negative for HPV at initial screening will finish their participation. HPV positive women will be: 1) referred to colposcopy, 2) invited for a second HPV screening round if not yet treated, and 3) referred to final colposcopy if HPV positive at second screening. Clinical management will be based on local histology.
Histology specimens will be externally reviewed by one highly experience international pathologist. If the local and external results are the same, this will become the final histology. If there is disagreement, the specimen will be sent to a third pathologist (be blinded to previous readings). The final diagnosis will then be that agreed by two pathologists (local and either external or both external). Remaining discrepancies will be solved by adjudication at a multi-headed microscope. Worst histology on review will be used to define outcome measures.
Measured: Detected after initial HPV screening or at second screening round 18 months since entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startMay 2013
- Primary completion30 Aug 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CIN3Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolando Herrero, MD, PhD, Principal investigator, International Agency for Research on Cancer (IARC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881659
- Sponsor's protocol ID
- IEC 12-27
- Acronym
- ESTAMPA
- Status last verified
- Mar 2023
- First submitted
- 17 Jun 2013
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baena A, Picconi MA, Mendoza L, Ferrera A, Mesher D, Lineros J, Brizuela M, Mongelos P, Cabrera Y, Fellner MD, Zambrana O, Garcia L, Hernandez P, Bobadilla ML, Ramon M, Venegas G, Villagra V, Cruz A, Rodriguez G, Teran C, Calderon A, Wiesner C, Herrero R, Almonte M; ESTAMPA study group. Short-term repeat HPV testing for triaging HPV-positive women in cervical cancer screening. Br J Cancer. 2025 Dec;133(12):1844-1853. doi: 10.1038/s41416-025-03193-0. Epub 2025 Oct 3.
PubMed 41044173Kacperczyk-Bartnik J, El Hajj H, Toth I, Bizzarri N, Toth R, Razumova Z, Zwimpfer TA, Taumberger N, Bilir E, Strojna A, Angeles MA, Gasimli K, Nikolova T, Bartnik P, Cokan A, Sari SY, Kahramanoglu I, Caruso G, Joura EA, Kyrgiou M, Kesic V, Fagotti A, Arbyn M, Gultekin M. Declaration on cervical cancer elimination: literature review and perspectives from early-career clinicians. Int J Gynecol Cancer. 2025 Jul;35(7):101902. doi: 10.1016/j.ijgc.2025.101902. Epub 2025 Apr 26.
PubMed 40435891Baena A, Mesher D, Salgado Y, Martinez S, Villalba GR, Amarilla ML, Salgado B, Flores B, Bellido-Fuentes Y, Alvarez-Larraondo M, Valls J, Lora O, Virreira-Prout G, Figueroa J, Turcios E, Soilan AM, Ortega M, Celis M, Gonzalez M, Venegas G, Teran C, Ferrera A, Mendoza L, Kasamatsu E, Murillo R, Wiesner C, Broutet N, Luciani S, Herrero R, Almonte M; ESTAMPA study group. Performance of visual inspection of the cervix with acetic acid (VIA) for triage of HPV screen-positive women: results from the ESTAMPA study. Int J Cancer. 2023 Apr 15;152(8):1581-1592. doi: 10.1002/ijc.34384. Epub 2022 Dec 7.
PubMed 36451311Almonte M, Murillo R, Sanchez GI, Gonzalez P, Ferrera A, Picconi MA, Wiesner C, Cruz-Valdez A, Lazcano-Ponce E, Jeronimo J, Ferreccio C, Kasamatsu E, Mendoza L, Rodriguez G, Calderon A, Venegas G, Villagra V, Tatti S, Fleider L, Teran C, Baena A, Hernandez ML, Rol ML, Lucas E, Barbier S, Ramirez AT, Arrossi S, Rodriguez MI, Gonzalez E, Celis M, Martinez S, Salgado Y, Ortega M, Beracochea AV, Perez N, Rodriguez de la Pena M, Ramon M, Hernandez-Nevarez P, Arboleda-Naranjo M, Cabrera Y, Salgado B, Garcia L, Retana MA, Colucci MC, Arias-Stella J, Bellido-Fuentes Y, Bobadilla ML, Olmedo G, Brito-Garcia I, Mendez-Herrera A, Cardinal L, Flores B, Penaranda J, Martinez-Better J, Soilan A, Figueroa J, Caserta B, Sosa C, Moreno A, Mural J, Doimi F, Gimenez D, Rodriguez H, Lora O, Luciani S, Broutet N, Darragh T, Herrero R. Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol. BMJ Open. 2020 May 24;10(5):e035796. doi: 10.1136/bmjopen-2019-035796.
PubMed 32448795Robles C, Wiesner C, Martinez S, Salgado Y, Hernandez M, Lucas E, Lineros J, Romero P, Herrero R, Almonte M, Murillo R. Impact of operational factors on HPV positivity rates in an HPV-based screening study in Colombia. Int J Gynaecol Obstet. 2018 Oct;143(1):44-51. doi: 10.1002/ijgo.12574. Epub 2018 Jul 16.
PubMed 29944728
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study of Cervical Cancer Screening and Triage With Human Papillomavirus (HPV) Testing
- ClinicalTrials.gov ID
- NCT01881659
- Acronym / sponsor ID
- ESTAMPA / IEC 12-27
- Conditions
- CIN3, CIN2, Cervical Cancer
- Keywords
- cervical cancer, cancer prevention, cervical screening, HPV testing, triage techniques
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Jun 2013 (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.
HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension of screening intervals. However, a single HPV test has low positive predictive value and can lead to unnecessary workup and over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000 women with HPV testing and compare several triage approaches that can follow HPV testing in order to make an HPV-based screening programme efficient, affordable and sustainable.
Detailed description
The study will be conducted in several Latin American countries. Currently, the study has started in one site in Colombia and soon another site in Mexico will start. In each participating center, women aged 30-64 years who are attending clinics for cervical screening will be invited to participate in the study. Women who agree to participate and sign the corresponding Institutional Review Board (IRB) approved consent forms will undergo a pelvic examination, and cervical cells for primary screening and triage will be collected. Recruitment specimens will be used for primary screening with an established HPV DNA test (Food and Drug Administration FDA approved). All women who are HPV-positive by the recruitment test will be referred for a standardized colposcopy examination for diagnosis. At the colposcopy visit, but before colposcopy is performed, a risk factor interview will be administered and participants will undergo visual inspection of the cervix with acetic acid (VIA) and collection of additional cervical cells and a blood specimen. The results of VIA will not be disclosed to the colposcopist. During colposcopy, the colposcopists will obtain (2-4) biopsies from any abnormally-appearing areas to ascertain neoplastic outcomes (CIN3+) and to direct treatment as required. All women who attend colposcopy will have a second round of HPV testing approximately 18 months after recruitment and those who are HPV-positive will be referred to colposcopy for final diagnosis. Data management and study supervision will be the responsibility of the International Agency for Research on Cancer (IARC) and the local Principal Investigators, most of whom are experienced HPV researchers.
The combined number of histologically-confirmed diagnoses of CIN3+, including CIN2 lesions positive for p16, (estimated n=500) will be the outcome of primary interest for evaluation of the performance of the various triage modalities. Our initial analyses will focus on comparisons of triage strategies that employ a single method: VIA, conventional/liquid-based cytology, HPV DNA genotyping, HPV RNA detection, detection of E6 proteins of high risk HPV types, or markers of HPV-induced cell-cycle alterations (e.g., p16, ki67, etc). To the extent possible, molecular testing for HPV triage will be carried out on the recruitment specimens to simulate a 'reflex testing' approach wherein screening and triage are done on the same specimen without additional visits. Subsequent analyses will consider various alternative strategies that employ more than one triage methodology; e.g., HPV DNA genotyping followed by cytology. The effectiveness and costs of each alternative strategy will be assessed under various scenarios of feasibility, cost, and effectiveness.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women attending cervical screening | – | Other: HPV screeningWomen aged 30-64 years who signed informed consent and comply with inclusion and exclusion criteria. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This is a multicentric study to be carried out in countries across the Latin American region. At each site, a census of all women 28-64 years of age residents of the selected area will be done previously to the start of the study. All women will then be invited using different approaches to the local health centers where screening is to happen.
Key inclusion criteria (4 listed)
- Aged 30-64 years
- Mentally competent to be able to understand the consent form
- Able to communicate with study staff
- Physically able to have a pelvic exam
Key exclusion criteria (6 listed)
- Reporting no previous sexual activity
- History of cervical cancer
- Previous treatment for cervical pre-cancer in the last six months
- Hysterectomy
- Plans to move out of the study area in the next 12 months
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 |
|---|---|---|
| HPV screeningWomen who signed informed consent will be screened with HPV testing. | Other | Women attending cervical screening |
Primary outcome
Number of participants with histologically confirmed cervical intraepithelial neoplasia grade 3 or cancer (CIN3+), including CIN2 positive for p16, on reviewed histology
Time frame: Detected after initial HPV screening or at second screening round 18 months since entry
There will be two HPV screening rounds. Women who test negative for HPV at initial screening will finish their participation. HPV positive women will be: 1) referred to colposcopy, 2) invited for a second HPV screening round if not yet treated, and 3) referred to final colposcopy if HPV positive at second screening. Clinical management will be based on local histology. Histology specimens will be externally reviewed by one highly experience international pathologist. If the local and external results are the same, this will become the final histology. If there is disagreement, the specimen will be sent to a third pathologist (be blinded to previous readings). The final diagnosis will then be that agreed by two pathologists (local and either external or both external). Remaining discrepancies will be solved by adjudication at a multi-headed microscope. Worst histology on review will be used to define outcome measures.
1 secondary outcome
Number of participants with histologically confirmed CIN2, CIN3 or cancer (CIN2+) on reviewed histology
Time frame: Detected after initial HPV screening or at second screening round 18 months since entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 41044173Baena A, Picconi MA, Mendoza L, Ferrera A, Mesher D, Lineros J, Brizuela M, Mongelos P, Cabrera Y, Fellner MD, Zambrana O, Garcia L, Hernandez P, Bobadilla ML, Ramon M, Venegas G, Villagra V, Cruz A, Rodriguez G, Teran C, Calderon A, Wiesner C, Herrero R, Almonte M; ESTAMPA study group. Short-term repeat HPV testing for triaging HPV-positive women in cervical cancer screening. Br J Cancer. 2025 Dec;133(12):1844-1853. doi: 10.1038/s41416-025-03193-0. Epub 2025 Oct 3.
- Derived from this study: PubMed 40435891Kacperczyk-Bartnik J, El Hajj H, Toth I, Bizzarri N, Toth R, Razumova Z, Zwimpfer TA, Taumberger N, Bilir E, Strojna A, Angeles MA, Gasimli K, Nikolova T, Bartnik P, Cokan A, Sari SY, Kahramanoglu I, Caruso G, Joura EA, Kyrgiou M, Kesic V, Fagotti A, Arbyn M, Gultekin M. Declaration on cervical cancer elimination: literature review and perspectives from early-career clinicians. Int J Gynecol Cancer. 2025 Jul;35(7):101902. doi: 10.1016/j.ijgc.2025.101902. Epub 2025 Apr 26.
- Derived from this study: PubMed 36451311Baena A, Mesher D, Salgado Y, Martinez S, Villalba GR, Amarilla ML, Salgado B, Flores B, Bellido-Fuentes Y, Alvarez-Larraondo M, Valls J, Lora O, Virreira-Prout G, Figueroa J, Turcios E, Soilan AM, Ortega M, Celis M, Gonzalez M, Venegas G, Teran C, Ferrera A, Mendoza L, Kasamatsu E, Murillo R, Wiesner C, Broutet N, Luciani S, Herrero R, Almonte M; ESTAMPA study group. Performance of visual inspection of the cervix with acetic acid (VIA) for triage of HPV screen-positive women: results from the ESTAMPA study. Int J Cancer. 2023 Apr 15;152(8):1581-1592. doi: 10.1002/ijc.34384. Epub 2022 Dec 7.
- Derived from this study: PubMed 32448795Almonte M, Murillo R, Sanchez GI, Gonzalez P, Ferrera A, Picconi MA, Wiesner C, Cruz-Valdez A, Lazcano-Ponce E, Jeronimo J, Ferreccio C, Kasamatsu E, Mendoza L, Rodriguez G, Calderon A, Venegas G, Villagra V, Tatti S, Fleider L, Teran C, Baena A, Hernandez ML, Rol ML, Lucas E, Barbier S, Ramirez AT, Arrossi S, Rodriguez MI, Gonzalez E, Celis M, Martinez S, Salgado Y, Ortega M, Beracochea AV, Perez N, Rodriguez de la Pena M, Ramon M, Hernandez-Nevarez P, Arboleda-Naranjo M, Cabrera Y, Salgado B, Garcia L, Retana MA, Colucci MC, Arias-Stella J, Bellido-Fuentes Y, Bobadilla ML, Olmedo G, Brito-Garcia I, Mendez-Herrera A, Cardinal L, Flores B, Penaranda J, Martinez-Better J, Soilan A, Figueroa J, Caserta B, Sosa C, Moreno A, Mural J, Doimi F, Gimenez D, Rodriguez H, Lora O, Luciani S, Broutet N, Darragh T, Herrero R. Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol. BMJ Open. 2020 May 24;10(5):e035796. doi: 10.1136/bmjopen-2019-035796.
- Derived from this study: PubMed 29944728Robles C, Wiesner C, Martinez S, Salgado Y, Hernandez M, Lucas E, Lineros J, Romero P, Herrero R, Almonte M, Murillo R. Impact of operational factors on HPV positivity rates in an HPV-based screening study in Colombia. Int J Gynaecol Obstet. 2018 Oct;143(1):44-51. doi: 10.1002/ijgo.12574. Epub 2018 Jul 16.
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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.
Rolando Herrero, MD, PhD principal investigator
International Agency for Research on Cancer (IARC)
12 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CIN3 and CIN2, run by International Agency for Research on Cancer at 12 sites in 9 countries.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Argentina, Colombia, Paraguay, Bolivia, Costa Rica and 4 more countries. 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?
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?
Number of participants with histologically confirmed cervical intraepithelial neoplasia grade 3 or cancer (CIN3+), including CIN2 positive for p16, on reviewed histology (time frame: Detected after initial HPV screening or at second screening round 18 months since entry). 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 NCT01881659, which also lists 5 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 14 Mar 2023.