Cervical Intraepithelial NeoplasiaTOPIC-3NCT02917746
Imiquimod Treatment of High-grade CIN
A study testing Imiquimod and Large Loop Excision of the Transformation Zone in people with Cervical Intraepithelial Neoplasia, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
This multi-center, open-label, non-randomized controlled intervention study aims to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by Large Loop Excision of the Transformation Zone (LLETZ). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Imiquimod and Large Loop Excision of the Transformation Zone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesNetherlands
- Study dates
- Nov 2016to Dec 2020
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
- age of 18 years or older
Who cannot join
- previous histologically confirmed high-grade CIN (CIN 2-3)
- concomitant vulvar and/or vaginal intraepithelial neoplasia
- previous cervical malignancy
- current malignant disease
- immunodeficiency (including HIV/AIDS and immunodepressive medication)
- pregnancy or lactation
- legal incapability
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Meander Medical Center
Amersfoort
Maastricht University Medical Center
Maastricht, 6202AZ
Erasmus Medical Center
Rotterdam
About this study
Official title: TOPical Imiquimod Treatment of High-grade Cervical Intraepithelial Neoplasia, a Multicenter, Open-label, Non-randomized, Controlled Study (TOPIC-3 Study)
This multi-center, open-label, non-randomized controlled intervention study aims to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent side-effects associated with surgical treatment, such as premature birth in subsequent pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN will be adequately treated with imiquimod.
120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference:
- Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks.
- Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.
Read the detailed description
Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of cervical cancer. The standard treatment of histologically confirmed CIN2-3 is surgical excision by large loop excision of the transformation zone (LLETZ). This procedure has potential complications, such as hemorrhage, infection and preterm birth in subsequent pregnancies. For this reason, non-invasive therapies are needed. Imiquimod cream has been studied as a non-invasive treatment alternative in high-grade CIN, but evidence on treatment efficacy is limited and evidence on disease recurrence and quality of life during and after treatment is lacking. One RCT has been performed and shows that treatment of high-grade CIN with vaginal imiquimod cream leads to disease regression in 73%. Side-effects were generally mild, but common. A recent survey among gynecologists and a patient preference study indicate that imiquimod treatment of high-grade CIN is mainly preferred by a selected population of women with a future pregnancy wish. These women accept a lower treatment efficacy and higher rates of side-effects from imiquimod treatment in order to prevent future preterm birth caused by LLETZ treatment. Ideally, those women with a high probability of successful treatment would be selected.
The objective of this study is to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions in a selected population of patients who prefer imiquimod treatment instead of LLETZ. The study also aims to identify predictive biomarkers clinical response to imiquimod treatment, in order to select patients in which good treatment response is expected.
The study design is a multicenter, open-label, non-randomized controlled intervention study. 120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference:
- Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks.
- Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.
A control colposcopy will be performed after 10 weeks for the imiquimod group. In case of progressive disease, the treatment will be ended and LLETZ will be performed as treatment. For patients in which the treatment is continued, treatment efficacy will be evaluated after 20 weeks, by colposcopy with diagnostic biopsies. Statistical analysis will be performed based on an intention-to-treat analysis.
The primary study endpoints are:
- Treatment efficacy of imiquimod and LLETZ treatment, defined as regression to CIN1 or less after 20 weeks for imiquimod and no need for additional therapy within 6 months for LLETZ treatment.
- Identification of predictive biomarkers for the efficacy of imiquimod treatment in the individual patient, based on biomarkers reflecting host, virus and cellular factors.
Secondary study endpoints are:
- Side effects of imiquimod therapy and LLETZ therapy.
- Disease recurrence at 6, 12 and 24 months follow-up.
- Quality of life (QoL) before, during and after treatment.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Imiquimod, Large Loop Excision of the Transformation Zone
- Keywords
- Cervical intraepithelial neoplasia, Imiquimod, Treatment, Predictive biomarkers
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Patients in this group are treated with vaginal imiquimod cream during 16 weeks. A control colposcopy with diagnostic biopsies will be performed after 10 weeks to rule out disease progression. A final colposcopy with diagnostic biopsies will be performed after 20 weeks to evaluate disease efficacy.
Large Loop Excision of the Transformation ZoneProcedure or surgery
Patients in this group are treated with LLETZ.
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod treatment arm | Experimental | Treatment by vaginal imiquimod cream during 16 weeks. Receives: Drug: Imiquimod |
| Standard treatment arm | Active comparator | Treatment by large loop excision of the transformation zone. Receives: Procedure: Large Loop Excision of the Transformation Zone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy of imiquimod 5% cream for the treatment of CIN2-3 lesions, compared to LLETZ treatment, in selected populations.
Treatment efficacy for the imiquimod group is defined as regression to CIN 1 or less at 20 weeks follow-up. Treatment efficacy for the standard treatment group is defined as no need for additional treatment within 6 months after LLETZ treatment.
Measured: 6 months
Identification of predictive biomarkers for treatment efficacy of imiquimod in the individual patient.
Histological biomarkers will be identified in the cervical biopsies performed at baseline.
Measured: Baseline (T=0)
Secondary outcomes (5)
Side effects of imiquimod therapy and LLETZ therapy.
Scored by the Common Terminology Criteria for Adverse Events guidelines.
Measured: 20 weeks
Disease recurrence
Defined as abnormal cervical cytology for all treatment groups.
Measured: 6, 12 and 24 months
General health-related Quality of life (QoL) before, during and after treatment
Medical Outcomes Study 36-Item Short-Form General Health Survey (RAND 36)
Measured: Baseline, 20 weeks and 1 year
Cancer specific Quality of Life, during and after treatment
European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire: QLQ-C30
Measured: Baseline, 20 weeks and 1 year
Cervical cancer specific Quality of life (QoL), during and after treatment
European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire: QLQ-CX24
Measured: Baseline, 20 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2018
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Center Maastricht B.V.
- Responsible party
- Sponsor
- Investigators
- A.J. Kruse, MD, PhD, Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917746
- Sponsor's protocol ID
- NL 57849.068.16
- Acronym
- TOPIC-3
- Status last verified
- May 2018
- First submitted
- 16 Sep 2016
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Crane JM. Pregnancy outcome after loop electrosurgical excision procedure: a systematic review. Obstet Gynecol. 2003 Nov;102(5 Pt 1):1058-62. doi: 10.1016/s0029-7844(03)00741-5.
PubMed 14672487Kyrgiou M, Koliopoulos G, Martin-Hirsch P, Arbyn M, Prendiville W, Paraskevaidis E. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis. Lancet. 2006 Feb 11;367(9509):489-98. doi: 10.1016/S0140-6736(06)68181-6.
PubMed 16473126Grimm C, Polterauer S, Natter C, Rahhal J, Hefler L, Tempfer CB, Heinze G, Stary G, Reinthaller A, Speiser P. Treatment of cervical intraepithelial neoplasia with topical imiquimod: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.
PubMed 22914404Pachman DR, Barton DL, Clayton AC, McGovern RM, Jefferies JA, Novotny PJ, Sloan JA, Loprinzi CL, Gostout BS. Randomized clinical trial of imiquimod: an adjunct to treating cervical dysplasia. Am J Obstet Gynecol. 2012 Jan;206(1):42.e1-7. doi: 10.1016/j.ajog.2011.06.105. Epub 2011 Jul 13.
PubMed 21907959Lin CT, Qiu JT, Wang CJ, Chang SD, Tang YH, Wu PJ, Jung SM, Huang CC, Chou HH, Jao MS, Lai CH. Topical imiquimod treatment for human papillomavirus infection in patients with and without cervical/vaginal intraepithelial neoplasia. Taiwan J Obstet Gynecol. 2012 Dec;51(4):533-8. doi: 10.1016/j.tjog.2012.09.006.
PubMed 23276555Koeneman MM, van de Sande AJ, van Beekhuizen HJ, Gerestein KG, van de Laar R, Kruitwagen RF, Kruse AJ. Physicians' Awareness, Attitudes, and Experiences Regarding Imiquimod Treatment of Vaginal and Cervical Intraepithelial Neoplasia. J Low Genit Tract Dis. 2016 Jan;20(1):75-9. doi: 10.1097/LGT.0000000000000158.
PubMed 26579838Koeneman MM, Kruse AJ, Kooreman LF, Zur Hausen A, Hopman AH, Sep SJ, Van Gorp T, Slangen BF, van Beekhuizen HJ, van de Sande AJ, Gerestein CG, Nijman HW, Kruitwagen RF. Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial. BMC Cancer. 2017 Feb 7;17(1):110. doi: 10.1186/s12885-017-3108-9.
PubMed 28173776
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOPical Imiquimod Treatment of High-grade Cervical Intraepithelial Neoplasia, a Multicenter, Open-label, Non-randomized, Controlled Study (TOPIC-3 Study)
- ClinicalTrials.gov ID
- NCT02917746
- Acronym / sponsor ID
- TOPIC-3 / NL 57849.068.16
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Cervical intraepithelial neoplasia, Imiquimod, Treatment, Predictive biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Clinical Trial Center Maastricht B.V.
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Sep 2016 (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 multi-center, open-label, non-randomized controlled intervention study aims to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent side-effects associated with surgical treatment, such as premature birth in subsequent pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN will be adequately treated with imiquimod.
120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference:
- Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks.
- Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.
Detailed description
Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of cervical cancer. The standard treatment of histologically confirmed CIN2-3 is surgical excision by large loop excision of the transformation zone (LLETZ). This procedure has potential complications, such as hemorrhage, infection and preterm birth in subsequent pregnancies. For this reason, non-invasive therapies are needed. Imiquimod cream has been studied as a non-invasive treatment alternative in high-grade CIN, but evidence on treatment efficacy is limited and evidence on disease recurrence and quality of life during and after treatment is lacking. One RCT has been performed and shows that treatment of high-grade CIN with vaginal imiquimod cream leads to disease regression in 73%. Side-effects were generally mild, but common. A recent survey among gynecologists and a patient preference study indicate that imiquimod treatment of high-grade CIN is mainly preferred by a selected population of women with a future pregnancy wish. These women accept a lower treatment efficacy and higher rates of side-effects from imiquimod treatment in order to prevent future preterm birth caused by LLETZ treatment. Ideally, those women with a high probability of successful treatment would be selected.
The objective of this study is to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions in a selected population of patients who prefer imiquimod treatment instead of LLETZ. The study also aims to identify predictive biomarkers clinical response to imiquimod treatment, in order to select patients in which good treatment response is expected.
The study design is a multicenter, open-label, non-randomized controlled intervention study. 120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference:
- Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks.
- Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.
A control colposcopy will be performed after 10 weeks for the imiquimod group. In case of progressive disease, the treatment will be ended and LLETZ will be performed as treatment. For patients in which the treatment is continued, treatment efficacy will be evaluated after 20 weeks, by colposcopy with diagnostic biopsies. Statistical analysis will be performed based on an intention-to-treat analysis.
The primary study endpoints are:
- Treatment efficacy of imiquimod and LLETZ treatment, defined as regression to CIN1 or less after 20 weeks for imiquimod and no need for additional therapy within 6 months for LLETZ treatment.
- Identification of predictive biomarkers for the efficacy of imiquimod treatment in the individual patient, based on biomarkers reflecting host, virus and cellular factors.
Secondary study endpoints are:
- Side effects of imiquimod therapy and LLETZ therapy.
- Disease recurrence at 6, 12 and 24 months follow-up.
- Quality of life (QoL) before, during and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imiquimod treatment arm | Experimental | Drug: ImiquimodTreatment by vaginal imiquimod cream during 16 weeks. |
| Standard treatment arm | Active comparator | Procedure: Large Loop Excision of the Transformation ZoneTreatment by large loop excision of the transformation zone. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
- age of 18 years or older
Key exclusion criteria (7 listed)
- previous histologically confirmed high-grade CIN (CIN 2-3)
- concomitant vulvar and/or vaginal intraepithelial neoplasia
- previous cervical malignancy
- current malignant disease
- immunodeficiency (including HIV/AIDS and immunodepressive medication)
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 |
|---|---|---|
| ImiquimodPatients in this group are treated with vaginal imiquimod cream during 16 weeks. A control colposcopy with diagnostic biopsies will be performed after 10 weeks to rule out disease progression. A final colposcopy with diagnostic biopsies will be performed after 20 weeks to evaluate disease efficacy. | Drug | Imiquimod treatment arm |
| Large Loop Excision of the Transformation ZonePatients in this group are treated with LLETZ. | Procedure or surgery | Standard treatment arm |
Primary outcome
Treatment efficacy of imiquimod 5% cream for the treatment of CIN2-3 lesions, compared to LLETZ treatment, in selected populations.
Time frame: 6 months
Treatment efficacy for the imiquimod group is defined as regression to CIN 1 or less at 20 weeks follow-up. Treatment efficacy for the standard treatment group is defined as no need for additional treatment within 6 months after LLETZ treatment.
Identification of predictive biomarkers for treatment efficacy of imiquimod in the individual patient.
Time frame: Baseline (T=0)
Histological biomarkers will be identified in the cervical biopsies performed at baseline.
5 secondary outcomes
Side effects of imiquimod therapy and LLETZ therapy.
Time frame: 20 weeks
Disease recurrence
Time frame: 6, 12 and 24 months
General health-related Quality of life (QoL) before, during and after treatment
Time frame: Baseline, 20 weeks and 1 year
Cancer specific Quality of Life, during and after treatment
Time frame: Baseline, 20 weeks and 1 year
Cervical cancer specific Quality of life (QoL), during and after treatment
Time frame: Baseline, 20 weeks and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 14672487Crane JM. Pregnancy outcome after loop electrosurgical excision procedure: a systematic review. Obstet Gynecol. 2003 Nov;102(5 Pt 1):1058-62. doi: 10.1016/s0029-7844(03)00741-5.
- Background: PubMed 16473126Kyrgiou M, Koliopoulos G, Martin-Hirsch P, Arbyn M, Prendiville W, Paraskevaidis E. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis. Lancet. 2006 Feb 11;367(9509):489-98. doi: 10.1016/S0140-6736(06)68181-6.
- Background: PubMed 22914404Grimm C, Polterauer S, Natter C, Rahhal J, Hefler L, Tempfer CB, Heinze G, Stary G, Reinthaller A, Speiser P. Treatment of cervical intraepithelial neoplasia with topical imiquimod: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.
- Background: PubMed 21907959Pachman DR, Barton DL, Clayton AC, McGovern RM, Jefferies JA, Novotny PJ, Sloan JA, Loprinzi CL, Gostout BS. Randomized clinical trial of imiquimod: an adjunct to treating cervical dysplasia. Am J Obstet Gynecol. 2012 Jan;206(1):42.e1-7. doi: 10.1016/j.ajog.2011.06.105. Epub 2011 Jul 13.
- Background: PubMed 23276555Lin CT, Qiu JT, Wang CJ, Chang SD, Tang YH, Wu PJ, Jung SM, Huang CC, Chou HH, Jao MS, Lai CH. Topical imiquimod treatment for human papillomavirus infection in patients with and without cervical/vaginal intraepithelial neoplasia. Taiwan J Obstet Gynecol. 2012 Dec;51(4):533-8. doi: 10.1016/j.tjog.2012.09.006.
- Background: PubMed 26579838Koeneman MM, van de Sande AJ, van Beekhuizen HJ, Gerestein KG, van de Laar R, Kruitwagen RF, Kruse AJ. Physicians' Awareness, Attitudes, and Experiences Regarding Imiquimod Treatment of Vaginal and Cervical Intraepithelial Neoplasia. J Low Genit Tract Dis. 2016 Jan;20(1):75-9. doi: 10.1097/LGT.0000000000000158.
- Derived from this study: PubMed 28173776Koeneman MM, Kruse AJ, Kooreman LF, Zur Hausen A, Hopman AH, Sep SJ, Van Gorp T, Slangen BF, van Beekhuizen HJ, van de Sande AJ, Gerestein CG, Nijman HW, Kruitwagen RF. Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial. BMC Cancer. 2017 Feb 7;17(1):110. doi: 10.1186/s12885-017-3108-9.
- Individual participant dataSharing planned: No
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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.
A.J. Kruse, MD, PhD study director
Maastricht University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imiquimod and Large Loop Excision of the Transformation Zone in people with Cervical Intraepithelial Neoplasia, run by Maastricht University Medical Center at 3 sites in Netherlands.
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 7 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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Treatment efficacy of imiquimod 5% cream for the treatment of CIN2-3 lesions, compared to LLETZ treatment, in selected populations. (time frame: 6 months). The study lists 2 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 NCT02917746, which also lists 7 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 16 Aug 2018.