Breast Cancer FemaleNCT03250260
Simulating Outcomes From Breast Conserving Surgery Using 3D Surface Imaging
A study testing 3-dimensional photograph with simulation and Viewing of a 2-dimensional photographic library in people with Breast Cancer Female, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Most women with breast cancer are able to have an operation to remove the cancer while preserving the breast (breast conserving therapy, BCT). Whilst cancer control is the most important goal, appearance of the breast after surgery has been shown to affect the quality of a woman's life after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- 3-dimensional photograph with simulation and Viewing of a 2-dimensional photographic library
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to 31 Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients Over 18 years Planned for unilateral breast conserving surgery at RMH Planned to receive adjuvant whole breast radiotherapy at RMH Willing to attend for study follow up visits.
Who cannot join
- Previous or concurrent surgery to the contralateral breast (previous breast conserving surgery, breast reduction or mastectomy)
- Previous surgery to the ipsilateral breast
- Unable to stand for long enough to have clinical photos (approximately 5 minutes)
- Unable to answer the BREAST-Q questionnaire (e.g. learning difficulties)
- Visually impaired (so that they could not view a 2D/3D images)
- Pre-operatively planning to have a symmetrisation procedure after radiotherapy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital
Sutton, Surrey, sm25pt
Julie Curtis, 02086616193, julie.curtis@rmh.nhs.uk
About this study
Official title: The Use of 3D Surface Imaging to Simulate Outcome After Breast Conserving Therapy
Most women with breast cancer are able to have an operation to remove the cancer while preserving the breast (breast conserving therapy, BCT). Whilst cancer control is the most important goal, appearance of the breast after surgery has been shown to affect the quality of a woman's life after treatment. This is even more relevant now that most women are surviving breast cancer.
Before surgery, women are prepared for how they will look afterwards by having a discussion with the Surgeon or Breast Care Nurse. Sometimes women are shown two dimensional (2D) (standard) photographs of other women who had a similar operation. Patients have stated that viewing photographs of other patients does not prepare them adequately for their own experience of surgery.
Read more
Three dimensional (3D) digital photography is currently being used to predict the appearance of the breasts after enlargement surgery using specialist software. The investigators intend to use a similar system to simulate a patient's appearance after BCT for cancer. The investigators believe that this will lead women to feel better prepared for their surgery, reduce stress, and lead to greater satisfaction with their breast after treatment.
This study invites women undergoing BCT to be assigned at random to one of three groups receiving standard care (discussion), a 2D photograph, or the 3D simulation before their operation. The investigators will find out whether women feel better prepared for surgery and are more satisfied with their outcome if they are shown a simulated image of how their own breasts are likely to look.
By taking 3D photographs of all study patients before and after surgery, a more accurate way to predict appearance after surgery will be developed for future patients.
Read the detailed description
Women who are planning to have breast conserving therapy (BCT) (surgery and radiotherapy, BCT) will be identified via two pathways: 1) via the Multi-Disciplinary Team Meeting (MDM) or 2) the consulting clinician. At their surgical outpatient appointment, the patients will be given written information to take away and read at their convenience. After at least 24 hours a member of the study team will telephone the patient to answer any further questions and to see whether they would like to be considered for the trial. Women who wish to participate will have a face-to-face meeting arranged with one of the co-investigators.
At the face-to-face meeting the investigators will go through the study in detail and ask the participant to sign a consent form to allow themselves to be included in the trial. The investigators will make it clear that participants can withdraw at any point during the study. The investigators will answer any further questions, take a baseline 3-D surface image (this is done by a member of the study team in a closed room with a lockable door with the offer of a chaperone), and issue a BCT BREAST-Q.
BCT BREAST-Q is a questionnaire which has been designed for women with breast cancer who are undergoing BCT to look at their quality of life and satisfaction with different aspects of their treatment and outcome. It is split into two sections, one to be filled in before, and one after treatment.
At the face-to-face meeting, the participants will be randomly allocated into 3 groups by a computer so the study team are not involved in the decision. This makes sure the allocation is fair. All women will receive the standard care for BCT which involves a conversation with surgeon and specialist breast care nurse.
Group 1 will receive standard care only. Group 2 will be shown photographs of women who have had BCT by a member of the study team .
Group 3 will be shown a real time simulation of how their own breast is likely to look after BCT.
The preparation for group 2 and 3 will take place in a quiet closed room with the patient and co-investigator and a friend or relative if the patient wishes.
Next, the participants will be asked to complete a Visual Analogue Scale (VAS) which is a ten point scale ranging from worst-to-best (0-10) where the participant is asked to place a cross along the scale to rate their response to a specific question. The question "How confident are you that you know how your breasts are likely to look after treatment?" will be used at this point. This will conclude the face-to-face meeting. The investigators estimate the visit will take 30-40 minutes in total.
In summary thus far, after the face-to-face meeting all study participants will have given written consent, had a baseline 3D-SI, been randomised, received their appropriate preparation depending on the group allocation, have filled in a VAS for "How confident are you that you know how your breasts are likely to look after treatment?", and will have been issued with a BREAST-Q BCT questionnaire to fill out while they are waiting for randomisation or their simulation or to fill in at home and bring with them on the day of surgery.
The follow up plans will include 3D-SI, a further VAS for the question "How well do you think the information you were given about how your breasts are likely to look after surgery (discussion, 2D photographs, or 3D simulation) reflects how they actually look today?", and BCT BREAST-Q.
The 3D-SI will be taken at two weeks after their surgery (to coincide with the routine outpatient surgical appointment), before radiotherapy (to coincide with the first session of radiotherapy), 3 months after radiotherapy (to coincide with the routine radiotherapy out-patient check-up), 6 months after radiotherapy (this will need to be an additional appointment - parking charges will be refunded), at 12 months following treatment (to coincide with their normal follow-up mammogram appointment), and then annually for 5 years (to coincide with their routine mammogram appointments).
The BCT BREAST-Q will be administered at 3 and 12 months post radiotherapy (at the same time as the 3D-SI appointments above), and then annually for 5 years (at the routine mammography appointments).
The VAS for "How well do you think the information you were given before surgery about how your breasts are likely to look after surgery (discussion, 2D photographs, or 3D simulation) reflects how they actually look today?" will be administered at 3 and 12 months post treatment. The results from the VAS before treatment will be analysed to show whether there was a difference between treatment groups in participants' preparedness for surgery.
The results from the BCT BREAST-Q will show whether there was a difference between groups for how satisfied participants were with the information given to them about BCT, satisfaction with their breast, and overall quality of life during and after BCT.
The 3D-SIs taken after at 3 and 12 months post BCT will be used for comparison with the simulation model in order to improve and make it as realistic as possible. The investigators will use the 3D-SI at all time points to look at how the breasts change over time up until five years following BCT.
The post operative VAS will be used to see if the participants thought their preparation for treatment matched reality following BCT. The investigators used three groups in this study as simulation for BCT has never been done before so the investigators do not know what the best method of preparation will be. However, most hospitals do not have access to a 3D camera and it may be that much of the benefit in terms of patient preparation and confidence can be achieved by reviewing photographs which would be more generalisable within the NHS. Hence the investigators also need to compare standard care with being shown 2D photographs, and 2D with 3D.
The investigators will be working from one hospital (one of the biggest breast cancer centres in the UK) where 8 BCT operations per week are performed. When looking at how long it would take to recruit enough women for the study to make the results meaningful the investigators presumed that only half of the women approached would want to participate (less then our previous experience with similar trials which was more than three quarters). With this in mind the investigators calculated it would take 30 weeks to gather enough participants into the trial.
The trial will finish 5 years after the last participant has finished BCT.
- Conditions
- Breast Cancer Female
- Being tested
- 3-dimensional photograph with simulation, Viewing of a 2-dimensional photographic library
- Keywords
- 3-dimensional imaging, Breast Conserving Treatment, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-dimensional photograph with simulationOther
The viewing of a 3-dimensional simulation is classed as an intervention as it strays from the normal pre-operative preparation.
Viewing of a 2-dimensional photographic libraryOther
The viewing of a 2-dimensional photograph library is classed as an intervention as it strays from the normal pre-operative preparation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Patient receives standard pre-operative preparation which involves a discussion in to the likely aesthetic outcome with their surgeon or specialist nurse |
| 2-dimensional Portfolio | Experimental | Patient views photographs of women matched for BMI, age, and breast volume who are 1-5 years post BCT pre-operatively. Receives: Other: Viewing of a 2-dimensional photographic library |
| 3-dimensional simulation | Experimental | Patient pre-operatively views a simulation of their own breast of their likely outcome after BCT. Receives: Other: 3-dimensional photograph with simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between groups in the mean pre-operative Visual Analogue Scale.
The mean VAS score (range: 0 -10mm) will be compared between groups. It is intended to assess preparedness for surgery of the women in each of the three arms. Patient scores in answer to the question "How confident are you that you know how your breasts are likely to look after treatment?" will be measured for each patient following randomisation and completion of their pre-operative preparation depending on study group.
Measured: preoperatively
Secondary outcomes (3)
The differences in post-operative 'Satisfaction with Information' scores between the 3 groups
The difference in mean BCT BREAST-Q 'satisfaction with information' domain scores will be compared between groups at 3 and 12 months post BCT. The mean of the 4 most relevant scales within the 'satisfaction with information' domain (6i-6l) will be compared between groups separately.
Measured: preoperatively , 3 months and 12 months
The difference in 'satisfaction with breasts' score pre and post-operatively between the 3 groups.
The mean difference between pre and post operative score for satisfaction with breasts will be compared between groups at 3 and 12 months.
Measured: preoperatively , 3 months and 12 months
The difference in 'Quality of Life' score pre and post-operatively between the 3 groups.
The mean difference between pre and post operative score for 'quality of life' will be compared between groups at 3 and 12 months.
Measured: preoperatively , 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 May 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250260
- Sponsor's protocol ID
- CCR 4660
- Status last verified
- Jul 2017
- First submitted
- 15 Jun 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Godden AR, Micha A, Wolf LM, Pitches C, Barry PA, Khan AA, Krupa KDC, Kirby AM, Rusby JE. Three-dimensional simulation of aesthetic outcome from breast-conserving surgery compared with viewing photographs or standard care: randomized clinical trial. Br J Surg. 2021 Oct 23;108(10):1181-1188. doi: 10.1093/bjs/znab217.
PubMed 34370833
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 3D Surface Imaging to Simulate Outcome After Breast Conserving Therapy
- ClinicalTrials.gov ID
- NCT03250260
- Acronym / sponsor ID
- CCR 4660
- Conditions
- Breast Cancer Female
- Keywords
- 3-dimensional imaging, Breast Conserving Treatment, Simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Aug 2017 (actual)
- 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.
Most women with breast cancer are able to have an operation to remove the cancer while preserving the breast (breast conserving therapy, BCT). Whilst cancer control is the most important goal, appearance of the breast after surgery has been shown to affect the quality of a woman's life after treatment. This is even more relevant now that most women are surviving breast cancer.
Before surgery, women are prepared for how they will look afterwards by having a discussion with the Surgeon or Breast Care Nurse. Sometimes women are shown two dimensional (2D) (standard) photographs of other women who had a similar operation. Patients have stated that viewing photographs of other patients does not prepare them adequately for their own experience of surgery.
Three dimensional (3D) digital photography is currently being used to predict the appearance of the breasts after enlargement surgery using specialist software. The investigators intend to use a similar system to simulate a patient's appearance after BCT for cancer. The investigators believe that this will lead women to feel better prepared for their surgery, reduce stress, and lead to greater satisfaction with their breast after treatment.
This study invites women undergoing BCT to be assigned at random to one of three groups receiving standard care (discussion), a 2D photograph, or the 3D simulation before their operation. The investigators will find out whether women feel better prepared for surgery and are more satisfied with their outcome if they are shown a simulated image of how their own breasts are likely to look.
By taking 3D photographs of all study patients before and after surgery, a more accurate way to predict appearance after surgery will be developed for future patients.
Detailed description
Women who are planning to have breast conserving therapy (BCT) (surgery and radiotherapy, BCT) will be identified via two pathways: 1) via the Multi-Disciplinary Team Meeting (MDM) or 2) the consulting clinician. At their surgical outpatient appointment, the patients will be given written information to take away and read at their convenience. After at least 24 hours a member of the study team will telephone the patient to answer any further questions and to see whether they would like to be considered for the trial. Women who wish to participate will have a face-to-face meeting arranged with one of the co-investigators.
At the face-to-face meeting the investigators will go through the study in detail and ask the participant to sign a consent form to allow themselves to be included in the trial. The investigators will make it clear that participants can withdraw at any point during the study. The investigators will answer any further questions, take a baseline 3-D surface image (this is done by a member of the study team in a closed room with a lockable door with the offer of a chaperone), and issue a BCT BREAST-Q.
BCT BREAST-Q is a questionnaire which has been designed for women with breast cancer who are undergoing BCT to look at their quality of life and satisfaction with different aspects of their treatment and outcome. It is split into two sections, one to be filled in before, and one after treatment.
At the face-to-face meeting, the participants will be randomly allocated into 3 groups by a computer so the study team are not involved in the decision. This makes sure the allocation is fair. All women will receive the standard care for BCT which involves a conversation with surgeon and specialist breast care nurse.
Group 1 will receive standard care only. Group 2 will be shown photographs of women who have had BCT by a member of the study team .
Group 3 will be shown a real time simulation of how their own breast is likely to look after BCT.
The preparation for group 2 and 3 will take place in a quiet closed room with the patient and co-investigator and a friend or relative if the patient wishes.
Next, the participants will be asked to complete a Visual Analogue Scale (VAS) which is a ten point scale ranging from worst-to-best (0-10) where the participant is asked to place a cross along the scale to rate their response to a specific question. The question "How confident are you that you know how your breasts are likely to look after treatment?" will be used at this point. This will conclude the face-to-face meeting. The investigators estimate the visit will take 30-40 minutes in total.
In summary thus far, after the face-to-face meeting all study participants will have given written consent, had a baseline 3D-SI, been randomised, received their appropriate preparation depending on the group allocation, have filled in a VAS for "How confident are you that you know how your breasts are likely to look after treatment?", and will have been issued with a BREAST-Q BCT questionnaire to fill out while they are waiting for randomisation or their simulation or to fill in at home and bring with them on the day of surgery.
The follow up plans will include 3D-SI, a further VAS for the question "How well do you think the information you were given about how your breasts are likely to look after surgery (discussion, 2D photographs, or 3D simulation) reflects how they actually look today?", and BCT BREAST-Q.
The 3D-SI will be taken at two weeks after their surgery (to coincide with the routine outpatient surgical appointment), before radiotherapy (to coincide with the first session of radiotherapy), 3 months after radiotherapy (to coincide with the routine radiotherapy out-patient check-up), 6 months after radiotherapy (this will need to be an additional appointment - parking charges will be refunded), at 12 months following treatment (to coincide with their normal follow-up mammogram appointment), and then annually for 5 years (to coincide with their routine mammogram appointments).
The BCT BREAST-Q will be administered at 3 and 12 months post radiotherapy (at the same time as the 3D-SI appointments above), and then annually for 5 years (at the routine mammography appointments).
The VAS for "How well do you think the information you were given before surgery about how your breasts are likely to look after surgery (discussion, 2D photographs, or 3D simulation) reflects how they actually look today?" will be administered at 3 and 12 months post treatment. The results from the VAS before treatment will be analysed to show whether there was a difference between treatment groups in participants' preparedness for surgery.
The results from the BCT BREAST-Q will show whether there was a difference between groups for how satisfied participants were with the information given to them about BCT, satisfaction with their breast, and overall quality of life during and after BCT.
The 3D-SIs taken after at 3 and 12 months post BCT will be used for comparison with the simulation model in order to improve and make it as realistic as possible. The investigators will use the 3D-SI at all time points to look at how the breasts change over time up until five years following BCT.
The post operative VAS will be used to see if the participants thought their preparation for treatment matched reality following BCT. The investigators used three groups in this study as simulation for BCT has never been done before so the investigators do not know what the best method of preparation will be. However, most hospitals do not have access to a 3D camera and it may be that much of the benefit in terms of patient preparation and confidence can be achieved by reviewing photographs which would be more generalisable within the NHS. Hence the investigators also need to compare standard care with being shown 2D photographs, and 2D with 3D.
The investigators will be working from one hospital (one of the biggest breast cancer centres in the UK) where 8 BCT operations per week are performed. When looking at how long it would take to recruit enough women for the study to make the results meaningful the investigators presumed that only half of the women approached would want to participate (less then our previous experience with similar trials which was more than three quarters). With this in mind the investigators calculated it would take 30 weeks to gather enough participants into the trial.
The trial will finish 5 years after the last participant has finished BCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Patient receives standard pre-operative preparation which involves a discussion in to the likely aesthetic outcome with their surgeon or specialist nurse |
| 2-dimensional Portfolio | Experimental | Other: Viewing of a 2-dimensional photographic libraryPatient views photographs of women matched for BMI, age, and breast volume who are 1-5 years post BCT pre-operatively. |
| 3-dimensional simulation | Experimental | Other: 3-dimensional photograph with simulationPatient pre-operatively views a simulation of their own breast of their likely outcome after BCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients Over 18 years Planned for unilateral breast conserving surgery at RMH Planned to receive adjuvant whole breast radiotherapy at RMH Willing to attend for study follow up visits.
Key exclusion criteria (6 listed)
- Previous or concurrent surgery to the contralateral breast (previous breast conserving surgery, breast reduction or mastectomy)
- Previous surgery to the ipsilateral breast
- Unable to stand for long enough to have clinical photos (approximately 5 minutes)
- Unable to answer the BREAST-Q questionnaire (e.g. learning difficulties)
- Visually impaired (so that they could not view a 2D/3D images)
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 |
|---|---|---|
| 3-dimensional photograph with simulationThe viewing of a 3-dimensional simulation is classed as an intervention as it strays from the normal pre-operative preparation. | Other | 3-dimensional simulation |
| Viewing of a 2-dimensional photographic libraryThe viewing of a 2-dimensional photograph library is classed as an intervention as it strays from the normal pre-operative preparation. | Other | 2-dimensional Portfolio |
Primary outcome
The difference between groups in the mean pre-operative Visual Analogue Scale.
Time frame: preoperatively
The mean VAS score (range: 0 -10mm) will be compared between groups. It is intended to assess preparedness for surgery of the women in each of the three arms. Patient scores in answer to the question "How confident are you that you know how your breasts are likely to look after treatment?" will be measured for each patient following randomisation and completion of their pre-operative preparation depending on study group.
3 secondary outcomes
The differences in post-operative 'Satisfaction with Information' scores between the 3 groups
Time frame: preoperatively , 3 months and 12 months
The difference in 'satisfaction with breasts' score pre and post-operatively between the 3 groups.
Time frame: preoperatively , 3 months and 12 months
The difference in 'Quality of Life' score pre and post-operatively between the 3 groups.
Time frame: preoperatively , 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Derived from this study: PubMed 34370833Godden AR, Micha A, Wolf LM, Pitches C, Barry PA, Khan AA, Krupa KDC, Kirby AM, Rusby JE. Three-dimensional simulation of aesthetic outcome from breast-conserving surgery compared with viewing photographs or standard care: randomized clinical trial. Br J Surg. 2021 Oct 23;108(10):1181-1188. doi: 10.1093/bjs/znab217.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-dimensional photograph with simulation and Viewing of a 2-dimensional photographic library in people with Breast Cancer Female, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 1 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 15 Aug 2017. 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 United Kingdom. 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?
Contact Jennifer E Rusby, BMBS, MD (02086613118, jennifer.rusby@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between groups in the mean pre-operative Visual Analogue Scale. (time frame: preoperatively). 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 NCT03250260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.