Human PapillomavirusSPANCNCT02007421
Study of the Prevention of Anal Cancer
A study testing Participants asked questions about recent experiences of anal intercourse in the last six months. and High Resolution Anoscopy in people with Human Papillomavirus and Cancer, run by Kirby Institute at 2 sites in Australia.
Trial summary
SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more than 90% of anal cancer. Gay men are over 20 times more likely than others to develop anal cancer. Read more about this study
- Who is it for?
- Ages 35 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus, Cancer
- What is being tested?
- Participants asked questions about recent experiences of anal intercourse in the last six months. and High Resolution Anoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 617 participants
- Where
- 2 sitesAustralia
- Study dates
- 10 Sep 2010to 4 Dec 2018
- Phase
- Interventional
- 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 35 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Male homosexual aged 35 years or above; HIV positive participants: documented to be HIV positive; HIV negative participants: tested HIV negative at recruitment; provision of informed, written consent.
-
Exclusion Criteria: participants unable to attend scheduled follow-up interviews or unwilling to undergo high resolution anoscopies (HRA); unable to understand English; having bleeding disorders or currently taking anti-coagulant medications; having previously received HRA; having ever been diagnosed with anal cancer.
-
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Applied Medical Research (AMR CRP), St. Vincent's Hospital
Sydney, New South Wales, 2010
RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown
Sydney, New South Wales, 2050
About this study
Official title: The Natural History of Anal Human Papillomavirus Infection and Anal Cellular Abnormalities in Homosexual Men
SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more than 90% of anal cancer.
Gay men are over 20 times more likely than others to develop anal cancer.
SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will provide important information to guide the possible future introduction of anal cancer screening programs for gay men.
Read the detailed description
Study title: The natural history of anal human papillomavirus (HPV) infection and anal cellular abnormalities in homosexual men.
Protocol version: 7, dated 1 September 2013. Approved by Ethics Committee on 24th October, 2013
Objectives: Among homosexual men aged 35 years or above to determine:
- Prevalence, incidence and risk factors for specific types of HPV infection.
- Prevalence, incidence and risk factors for histologically confirmed anal low grade and high grade squamous intraepithelial lesions (LSIL and HSIL).
- Type-specific rates of clearance and persistence of anal HPV infection.
- Rates of disease progression, regression and predictors in the spectrum of anal dysplasia.
- Psychosocial/quality of life impact of anal cytology screening in homosexual men.
Study results will be used to inform possible development of guidelines for carrying out an anal cancer screening program in this population.
The study design is a prospective longitudinal design. Upon enrolment, participants will be followed up for three years to allow the study of both prevalence and incidence of HPV infection and related conditions.
Planned sample size: 600 homosexual men will be screened and enrolled from community based settings in Sydney, Australia.
The inclusion criteria are:
- male homosexual aged 35 years or above;
- HIV positive participants: documented to be HIV positive;
- HIV negative participants: tested HIV negative at recruitment; provision of informed, written consent.
The exclusion criteria are:
- participants unable to attend scheduled follow-up interviews or unwilling to undergo high resolution anoscopies (HRA);
- unable to understand English;
- having bleeding disorders or currently taking anti-anticoagulant medications; *having previously received HRA;
- having ever been diagnosed with anal cancer.
Study procedures:
- At baseline, all men will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology.
- An HRA will also be performed on all men.
- Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visits in the first year and then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, blood collection (except at six month); an anal swab and HRA will be administered at all follow up interviews.
The SPANC study is a prospective cohort study of the national history of anal human papillomavirus (HPV) infection and anal cellular abnormalities in homosexual men aged 35 years and above in Sydney. It is expected that the study results will be influential in the possible development of an anal cancer screening program in high-risk populations. Data on the natural history of anal HPV infection in homosexual men recruited from community-based settings are rare. We aim to recruit a total of 600 men, 360 HIV-negative and 240 HIV-positive. This will make the SPANC study one of the biggest ongoing anal HPV natural history study in the world to provide critical data on the incidence and clearance of anal HPV infection, progression and regression of pre-cancerous HPV associated anal lesions, the potential psychological impact on men who participate anal cancer screening programs, and the cost-effectiveness of rolling out these programs.
Statistical considerations: Sample size calculation: Assuming the incidence of HSIL is 5 and 15 per cent 100 person-years in HIV negative and HIV positive men, respectively, the 95% confidence intervals will be 4.2-6.0 in the HIV negative arm and 12.6-17.8 per 100 person-years in the HIV positive arm. Analysis plan: HPV prevalence and incidence, including overall, low risk, high risk and individual types, will be calculated according to participant's HIV status. Prevalence and incidence of LSIL and HISL will be calculated in the same fashion. Clearance and persistence of HPV infection, and progression and regression of HSIL will also be determined. Risk factors for prevalent HPV infection and LSIL and HSIL will be analysed using logistical regression. Risk factors for incident conditions will be analysed using Cox regression.
Duration of the study: The study will take place from 13/September/2010 to 21/Dec/2018. Participants will be recruited from 2010 to 2015 and followed up for three years.
- Conditions
- Human Papillomavirus, Cancer
- Being tested
- Participants asked questions about recent experiences of anal intercourse in the last six months., High Resolution Anoscopy
- Keywords
- Human Papillomavirus,, Anal High Grade Squamous intraepithelial lesions,, Homosexual Men, High resolution anoscopy,, Cancer Screening, HIV
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants asked questions about recent experiences of anal intercourse in the last six months.Procedure or surgery
Also called Participants have venepuncture, anal swab and examination under microscope .
Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.
At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews.
High Resolution AnoscopyProcedure or surgery
Also called HRA
The HRA is performed on HIV positive and HIV negative participants by study doctor after an examination of the perianal region and perineum. The plastic anoscope is inserted into the anal canal and visualised under high resolution magnification. Biopsy samples will be taken by the clinician for histological assessment if there are any detected abnormalities.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive homosexual men | Other | Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.
At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews. Receives: Procedure: Participants asked questions about recent experiences of anal intercourse in the last six months.; Procedure: High Resolution Anoscopy |
| HIV negative homosexual men | Other | Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.
At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews. Receives: Procedure: Participants asked questions about recent experiences of anal intercourse in the last six months.; Procedure: High Resolution Anoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A natural history study to inform the potential usefulness of a cytology/HPV/HRA based screening program
Aims to determine the prevalence, incidence and risk factors for type-specific HPV (37 types)
Measured: 3 year cohort study
Secondary outcomes (1)
Prevalence, incidence and risk factors for LSIL and HSIL
To determine if HPV is associated with LSIL and HSIL
Measured: 3 year cohort study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study start10 Sep 2010
- Primary completion4 May 2018
- Study completion4 Dec 2018
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 Human PapillomavirusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Carmella Law, MBBS; FAChSHM;, Principal investigator, Appplied Medical Research, the Clinical Research Program at St. Vincent's HospitalDavid Templeton, MBChB; PhD;, Principal investigator, RPA Sexual Health, Royal Prince Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007421
- Sponsor's protocol ID
- SPANC
- Other IDs
- NHMRC
- Acronym
- SPANC
- Status last verified
- Nov 2019
- First submitted
- 26 Nov 2013
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Machalek DA, Grulich AE, Hillman RJ, Jin F, Templeton DJ, Tabrizi SN, Garland SM, Prestage G, McCaffery K, Howard K, Tong W, Fairley CK, Roberts J, Farnsworth A, Poynten IM; SPANC Study Team. The Study of the Prevention of Anal Cancer (SPANC): design and methods of a three-year prospective cohort study. BMC Public Health. 2013 Oct 9;13:946. doi: 10.1186/1471-2458-13-946.
PubMed 24107134Tong WW, Shepherd K, Garland S, Meagher A, Templeton DJ, Fairley CK, Jin F, Poynten IM, Zaunders J, Hillman RJ, Grulich AE, Kelleher AD, Carr A; Study of the Prevention of Anal Cancer (SPANC) team. Human papillomavirus 16-specific T-cell responses and spontaneous regression of anal high-grade squamous intraepithelial lesions. J Infect Dis. 2015 Feb 1;211(3):405-15. doi: 10.1093/infdis/jiu461. Epub 2014 Aug 19.
PubMed 25139018
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Anal Human Papillomavirus Infection and Anal Cellular Abnormalities in Homosexual Men
- ClinicalTrials.gov ID
- NCT02007421
- Acronym / sponsor ID
- SPANC / SPANC
- Conditions
- Human Papillomavirus, Cancer
- Keywords
- Human Papillomavirus,, Anal High Grade Squamous intraepithelial lesions,, Homosexual Men, High resolution anoscopy,, Cancer Screening, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 10 Sep 2010 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 10 Dec 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.
SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more than 90% of anal cancer.
Gay men are over 20 times more likely than others to develop anal cancer.
SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will provide important information to guide the possible future introduction of anal cancer screening programs for gay men.
Detailed description
Study title: The natural history of anal human papillomavirus (HPV) infection and anal cellular abnormalities in homosexual men.
Protocol version: 7, dated 1 September 2013. Approved by Ethics Committee on 24th October, 2013
Objectives: Among homosexual men aged 35 years or above to determine:
- Prevalence, incidence and risk factors for specific types of HPV infection.
- Prevalence, incidence and risk factors for histologically confirmed anal low grade and high grade squamous intraepithelial lesions (LSIL and HSIL).
- Type-specific rates of clearance and persistence of anal HPV infection.
- Rates of disease progression, regression and predictors in the spectrum of anal dysplasia.
- Psychosocial/quality of life impact of anal cytology screening in homosexual men.
Study results will be used to inform possible development of guidelines for carrying out an anal cancer screening program in this population.
The study design is a prospective longitudinal design. Upon enrolment, participants will be followed up for three years to allow the study of both prevalence and incidence of HPV infection and related conditions.
Planned sample size: 600 homosexual men will be screened and enrolled from community based settings in Sydney, Australia.
The inclusion criteria are:
- male homosexual aged 35 years or above;
- HIV positive participants: documented to be HIV positive;
- HIV negative participants: tested HIV negative at recruitment; provision of informed, written consent.
The exclusion criteria are:
- participants unable to attend scheduled follow-up interviews or unwilling to undergo high resolution anoscopies (HRA);
- unable to understand English;
- having bleeding disorders or currently taking anti-anticoagulant medications; *having previously received HRA;
- having ever been diagnosed with anal cancer.
Study procedures:
- At baseline, all men will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology.
- An HRA will also be performed on all men.
- Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visits in the first year and then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, blood collection (except at six month); an anal swab and HRA will be administered at all follow up interviews.
The SPANC study is a prospective cohort study of the national history of anal human papillomavirus (HPV) infection and anal cellular abnormalities in homosexual men aged 35 years and above in Sydney. It is expected that the study results will be influential in the possible development of an anal cancer screening program in high-risk populations. Data on the natural history of anal HPV infection in homosexual men recruited from community-based settings are rare. We aim to recruit a total of 600 men, 360 HIV-negative and 240 HIV-positive. This will make the SPANC study one of the biggest ongoing anal HPV natural history study in the world to provide critical data on the incidence and clearance of anal HPV infection, progression and regression of pre-cancerous HPV associated anal lesions, the potential psychological impact on men who participate anal cancer screening programs, and the cost-effectiveness of rolling out these programs.
Statistical considerations: Sample size calculation: Assuming the incidence of HSIL is 5 and 15 per cent 100 person-years in HIV negative and HIV positive men, respectively, the 95% confidence intervals will be 4.2-6.0 in the HIV negative arm and 12.6-17.8 per 100 person-years in the HIV positive arm. Analysis plan: HPV prevalence and incidence, including overall, low risk, high risk and individual types, will be calculated according to participant's HIV status. Prevalence and incidence of LSIL and HISL will be calculated in the same fashion. Clearance and persistence of HPV infection, and progression and regression of HSIL will also be determined. Risk factors for prevalent HPV infection and LSIL and HSIL will be analysed using logistical regression. Risk factors for incident conditions will be analysed using Cox regression.
Duration of the study: The study will take place from 13/September/2010 to 21/Dec/2018. Participants will be recruited from 2010 to 2015 and followed up for three years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive homosexual men | Other | Procedure: Participants asked questions about recent experiences of anal intercourse in the last six months., Procedure: High Resolution AnoscopyTherefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months. At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews. |
| HIV negative homosexual men | Other | Procedure: Participants asked questions about recent experiences of anal intercourse in the last six months., Procedure: High Resolution AnoscopyTherefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months. At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Participants asked questions about recent experiences of anal intercourse in the last six months.Also: Participants have venepuncture, anal swab and examination under microscope .Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months. At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews. | Procedure or surgery | HIV negative homosexual men, HIV positive homosexual men |
| High Resolution AnoscopyAlso: HRAThe HRA is performed on HIV positive and HIV negative participants by study doctor after an examination of the perianal region and perineum. The plastic anoscope is inserted into the anal canal and visualised under high resolution magnification. Biopsy samples will be taken by the clinician for histological assessment if there are any detected abnormalities. | Procedure or surgery | HIV negative homosexual men, HIV positive homosexual men |
Primary outcome
A natural history study to inform the potential usefulness of a cytology/HPV/HRA based screening program
Time frame: 3 year cohort study
Aims to determine the prevalence, incidence and risk factors for type-specific HPV (37 types)
1 secondary outcome
Prevalence, incidence and risk factors for LSIL and HSIL
Time frame: 3 year cohort 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 2 Dec 2019.
- Background: PubMed 24107134Machalek DA, Grulich AE, Hillman RJ, Jin F, Templeton DJ, Tabrizi SN, Garland SM, Prestage G, McCaffery K, Howard K, Tong W, Fairley CK, Roberts J, Farnsworth A, Poynten IM; SPANC Study Team. The Study of the Prevention of Anal Cancer (SPANC): design and methods of a three-year prospective cohort study. BMC Public Health. 2013 Oct 9;13:946. doi: 10.1186/1471-2458-13-946.
- Derived from this study: PubMed 25139018Tong WW, Shepherd K, Garland S, Meagher A, Templeton DJ, Fairley CK, Jin F, Poynten IM, Zaunders J, Hillman RJ, Grulich AE, Kelleher AD, Carr A; Study of the Prevention of Anal Cancer (SPANC) team. Human papillomavirus 16-specific T-cell responses and spontaneous regression of anal high-grade squamous intraepithelial lesions. J Infect Dis. 2015 Feb 1;211(3):405-15. doi: 10.1093/infdis/jiu461. Epub 2014 Aug 19.
- http://www.nchersurveys.unsw.edu.au/spancLink provided by the sponsor.
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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.
Carmella Law, MBBS; FAChSHM; principal investigator
Appplied Medical Research, the Clinical Research Program at St. Vincent's Hospital
David Templeton, MBChB; PhD; principal investigator
RPA Sexual Health, Royal Prince Alfred Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants asked questions about recent experiences of anal intercourse in the last six months. and High Resolution Anoscopy in people with Human Papillomavirus and Cancer, run by Kirby Institute at 2 sites in Australia.
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 2 Dec 2019. 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 Australia. 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?
A natural history study to inform the potential usefulness of a cytology/HPV/HRA based screening program (time frame: 3 year cohort study). 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 NCT02007421, 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 2 Dec 2019.