Breast CancerMAP-BCNCT05923164
Reliability And Validity Study Of "The Evaluation Tool For Myofascial Adhesions In Patients After Breast Cancer" In Turkish Language
An observational study of Breast Cancer and Upper Extremity Dysfunction, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to translate the MAP-BC Evaluation Tool into Turkish by adapting it to Turkish society and to conduct a validity and reliability study in women who have received breast cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Upper Extremity Dysfunction, Tissue Adhesion
- What is being tested?
- MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation Tool and Patient And Observer Scar Assessment Scale ( Observer Subscale)
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2023to 30 Jul 2024
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients, aged between 18-75 years, who have undergone breast cancer surgery, visiting our oncological rehabilitation outpatient clinic between August 2023 and March 2024
Who may be able to join
- Breast cancer patients aged between 18-75 years who had undergone breast surgery
- providing a written consent to participate in the study
Who cannot join
- Patients who do not agree to participate the study
- Patients with active skin disease/infection which limits physical examination (palpation)
- Patients with a secondary breast cancer and/or metastasis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Kadıköy
Özden Tömek, MD, Turkey: +905343284941, ozden.tomek@gmail.com
Gökçenur Yalçın, MD, gokcenur_cihaner@hotmail.com
About this study
Official title: Reliability And Validity Study Of MAP-BC Evaluation Tool In Turkish Language To Detect Myofascial Adhesions Among Women Under Breast Cancer Treatment
The aim of this observational study is to translate the MAP-BC Evaluation Tool into Turkish by adapting it to Turkish society and to conduct a validity and reliability study in women who have received breast cancer treatment.
The main questions it aims to answer are:
- Are the same researcher's MAP-BC Evaluation Tool results similar at intervals to detect myofascial adhesions in breast cancer patients in Turkish population?
- Are the different researchers' MAP-BC Evaluation Tool results similar to detect myofascial adhesions in breast cancer patients in Turkish population?
- After comparing the results of Turkish version of both The Patient and Observer Scar Assessment Scale Observer Subscale and MAP-BC Evaluation Tool, is there a sufficient correlation between them?
Read the detailed description
Breast cancer is the most frequently diagnosed malignancy in all over the world. Breast and axillary surgery, radiotherapy, hormone therapy and chemotherapy treatments may cause upper extremity dysfunction and pain which negatively affect quality of life and daily living activities of breast cancer patients.
Lymphedema, severe pain, decreased range of motion of shoulder joint, axillary web syndrome, myofascial trigger points and myofascial adhesions are the leading causes affecting upper extremity function in patients with breast cancer.
Myofascial dysfunction presents as a problem characterized by trigger points, adhesions, and limitation of myofascial tissue and tissue gliding.
Muscle manipulation during surgery, scar tissue, soft tissue adhesions, adaptive posture development following surgery and radiotherapy induced fibrosis can cause myofascial adhesions. However, there is not sufficient research or tools for the evaluation of scar tissue and adhesions.
Detection, quantitative measurement and scoring of myofascial adhesions in upper extremity dysfunctions after breast cancer treatment are important for both developing target-oriented treatment plan and evaluation of treatment effectiveness (myofascial therapy, physical therapy modalities).
The Patient and Observer Scar Assessment Scale is an evaluation tool utilized to detect scar tissue and was shown for reliable and valid in patients who have undergone breast cancer surgery. Its reliability and validity study for Turkish population has been done earlier.
A new diagnostic method called MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) has been developed to evaluate scar tissue after breast cancer treatments and to quantitatively measure myofascial adhesions. Its reliability and validity have been proven in various countries, however, it is yet to be tested in Turkey.
The aim of this observational study is to translate the MAP-BC evaluation tool into Turkish by adapting it to Turkish society and to conduct a validity and reliability study in women who have received breast cancer treatment.
Firstly, the original version of MAP-BC will be translated into Turkish and its semantic and conceptual equivalence will be checked. Later it will be finalized by the committee consisting of two translators and four expert physiatrists.
For intra-rater reliability, the same researcher will re-evaluate patients at 14-days intervals.
For inter-rater reliability, 2 different researchers will evaluate the first 15 patients by using the Patient and Observer Scar Assessment Scale and MAP-BC tools unaware of each other's results. If the outcome of the two researchers evaluation are found in agreement at a reliable rate, then the study will be continued by a single researcher.
The convergent validity of the Turkish version of MAP-BC will be assessed by comparing the results of Turkish version of both the Patient and Observer Scar Assessment Scale observer subscale (Patient and Observer Wound Assessment) and MAP-BC. Their correlation will be analyzed.
- Conditions
- Breast Cancer, Upper Extremity Dysfunction, Tissue Adhesion
- Being tested
- MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation Tool, Patient And Observer Scar Assessment Scale ( Observer Subscale)
- Keywords
- Myofascial adhesions, Breast Cancer, POSAS, MAP-BC Evaluation Tool, myofascial dysfunction, validity and reliability study
- Medical subject headings
- Breast Neoplasms, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation ToolDiagnostic test
It's a tool to evaluate scar tissues that occured after breast cancer treatment. It quantitatively measures myofascial adhesions. The degree of adhesion is scored for each area at 3 different depth levels (skin, superficial, deep) as a 4-point scale (0: no adhesion - 3: severe adhesion). Axillary scar, breast/mastectomy scar, m. pectoralis region, frontal chest wall, lateral chest wall, axilla and inframammary fold are evaluated separately. Sum of the scores from three levels of each area gives the total score. The minimal total score is: 0 and the maximum total score is 63.
Patient And Observer Scar Assessment Scale ( Observer Subscale)Diagnostic test
This assesment tool consists of two different scales evaluated by the observer and the patient.The observer scale rates five variables, which include vascularity, pigmentation, thickness, relief, pliability and surface area, between 1-10 points (1:normal skin). The total score ranges from 5 to 50.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients | Patients who had undergone breast cancer surgery, aged between 18-75 years-old Receives: Diagnostic Test: MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation Tool; Diagnostic Test: Patient And Observer Scar Assessment Scale ( Observer Subscale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP-BC Evaluation Tool
This tool was developed to evaluate scar tissues that occured after breast cancer treatments. It quantitatively measures myofascial adhesions. The degree of adhesion is scored for each area at 3 different depth levels (skin, superficial, deep) as a 4-point scale (0: no adhesion - 3: severe adhesion). Axillary scar, breast/mastectomy scar, m. pectoralis region, frontal chest wall, lateral chest wall, axilla and inframammary fold are evaluated separately. Sum of the scores from three levels of each area gives the total score. The maximum score is 63. In Breast cancer patients, the inter-rater reliability of the detection of myofascial adhesions by palpation has been reported good to excellent.
Measured: 11 months
POSAS
This assesment tool consists of two different scales evaluated by the observer and the patient. Its validity and reliability have been proven for the detection of scar tissue in patients who have undergone breast cancer surgery. The observer scale rates five variables, which include vascularity, pigmentation, thickness, relief, pliability and surface area, between 1-10 points (1:normal skin). The total score ranges from 5 to 50. The Turkish version of POSAS, whose validity and reliability studies were conducted, will be used in our study.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (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 Breast CancerStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeliz Bahar Özdemir, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923164
- Sponsor's protocol ID
- 23/337
- Acronym
- MAP-BC
- Status last verified
- Aug 2023
- First submitted
- 19 Jun 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc.
PubMed 17230080Lewit K, Olsanska S. Clinical importance of active scars: abnormal scars as a cause of myofascial pain. J Manipulative Physiol Ther. 2004 Jul-Aug;27(6):399-402. doi: 10.1016/j.jmpt.2004.05.004.
PubMed 15319762Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
PubMed 15804318Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735De Groef A, Van der Gucht E, Dams L, Evenepoel M, Teppers L, Toppet-Hoegars J, De Baets L. The association between upper limb function and variables at the different domains of the international classification of functioning, disability and health in women after breast cancer surgery: a systematic review. Disabil Rehabil. 2022 Apr;44(8):1176-1189. doi: 10.1080/09638288.2020.1800835. Epub 2020 Aug 8.
PubMed 32772650Seyyah M, Yurdalan SU. Cultural adaptation and validation of Patient and Observer Scar Assessment Scale for Turkish use. Burns. 2018 Aug;44(5):1352-1356. doi: 10.1016/j.burns.2018.02.026. Epub 2018 Mar 24.
PubMed 29580666De Groef A, Van Kampen M, Vervloesem N, De Geyter S, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. An evaluation tool for myofascial adhesions in patients after breast cancer (MAP-BC evaluation tool): Development and interrater reliability. PLoS One. 2017 Jun 9;12(6):e0179116. doi: 10.1371/journal.pone.0179116. eCollection 2017.
PubMed 28598978
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability And Validity Study Of MAP-BC Evaluation Tool In Turkish Language To Detect Myofascial Adhesions Among Women Under Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT05923164
- Acronym / sponsor ID
- MAP-BC / 23/337
- Conditions
- Breast Cancer, Upper Extremity Dysfunction, Tissue Adhesion
- Keywords
- Myofascial adhesions, Breast Cancer, POSAS, MAP-BC Evaluation Tool, myofascial dysfunction, validity and reliability study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 28 Jun 2023 (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.
The aim of this observational study is to translate the MAP-BC Evaluation Tool into Turkish by adapting it to Turkish society and to conduct a validity and reliability study in women who have received breast cancer treatment.
The main questions it aims to answer are:
- Are the same researcher's MAP-BC Evaluation Tool results similar at intervals to detect myofascial adhesions in breast cancer patients in Turkish population?
- Are the different researchers' MAP-BC Evaluation Tool results similar to detect myofascial adhesions in breast cancer patients in Turkish population?
- After comparing the results of Turkish version of both The Patient and Observer Scar Assessment Scale Observer Subscale and MAP-BC Evaluation Tool, is there a sufficient correlation between them?
Detailed description
Breast cancer is the most frequently diagnosed malignancy in all over the world. Breast and axillary surgery, radiotherapy, hormone therapy and chemotherapy treatments may cause upper extremity dysfunction and pain which negatively affect quality of life and daily living activities of breast cancer patients.
Lymphedema, severe pain, decreased range of motion of shoulder joint, axillary web syndrome, myofascial trigger points and myofascial adhesions are the leading causes affecting upper extremity function in patients with breast cancer.
Myofascial dysfunction presents as a problem characterized by trigger points, adhesions, and limitation of myofascial tissue and tissue gliding.
Muscle manipulation during surgery, scar tissue, soft tissue adhesions, adaptive posture development following surgery and radiotherapy induced fibrosis can cause myofascial adhesions. However, there is not sufficient research or tools for the evaluation of scar tissue and adhesions.
Detection, quantitative measurement and scoring of myofascial adhesions in upper extremity dysfunctions after breast cancer treatment are important for both developing target-oriented treatment plan and evaluation of treatment effectiveness (myofascial therapy, physical therapy modalities).
The Patient and Observer Scar Assessment Scale is an evaluation tool utilized to detect scar tissue and was shown for reliable and valid in patients who have undergone breast cancer surgery. Its reliability and validity study for Turkish population has been done earlier.
A new diagnostic method called MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) has been developed to evaluate scar tissue after breast cancer treatments and to quantitatively measure myofascial adhesions. Its reliability and validity have been proven in various countries, however, it is yet to be tested in Turkey.
The aim of this observational study is to translate the MAP-BC evaluation tool into Turkish by adapting it to Turkish society and to conduct a validity and reliability study in women who have received breast cancer treatment.
Firstly, the original version of MAP-BC will be translated into Turkish and its semantic and conceptual equivalence will be checked. Later it will be finalized by the committee consisting of two translators and four expert physiatrists.
For intra-rater reliability, the same researcher will re-evaluate patients at 14-days intervals.
For inter-rater reliability, 2 different researchers will evaluate the first 15 patients by using the Patient and Observer Scar Assessment Scale and MAP-BC tools unaware of each other's results. If the outcome of the two researchers evaluation are found in agreement at a reliable rate, then the study will be continued by a single researcher.
The convergent validity of the Turkish version of MAP-BC will be assessed by comparing the results of Turkish version of both the Patient and Observer Scar Assessment Scale observer subscale (Patient and Observer Wound Assessment) and MAP-BC. Their correlation will be analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | Diagnostic Test: MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation Tool, Diagnostic Test: Patient And Observer Scar Assessment Scale ( Observer Subscale)Patients who had undergone breast cancer surgery, aged between 18-75 years-old |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, aged between 18-75 years, who have undergone breast cancer surgery, visiting our oncological rehabilitation outpatient clinic between August 2023 and March 2024
Key inclusion criteria (2 listed)
- Breast cancer patients aged between 18-75 years who had undergone breast surgery
- providing a written consent to participate in the study
Key exclusion criteria (3 listed)
- Patients who do not agree to participate the study
- Patients with active skin disease/infection which limits physical examination (palpation)
- Patients with a secondary breast cancer and/or metastasis
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 |
|---|---|---|
| MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation ToolIt's a tool to evaluate scar tissues that occured after breast cancer treatment. It quantitatively measures myofascial adhesions. The degree of adhesion is scored for each area at 3 different depth levels (skin, superficial, deep) as a 4-point scale (0: no adhesion - 3: severe adhesion). Axillary scar, breast/mastectomy scar, m. pectoralis region, frontal chest wall, lateral chest wall, axilla and inframammary fold are evaluated separately. Sum of the scores from three levels of each area gives the total score. The minimal total score is: 0 and the maximum total score is 63. | Diagnostic test | Breast Cancer Patients |
| Patient And Observer Scar Assessment Scale ( Observer Subscale)This assesment tool consists of two different scales evaluated by the observer and the patient.The observer scale rates five variables, which include vascularity, pigmentation, thickness, relief, pliability and surface area, between 1-10 points (1:normal skin). The total score ranges from 5 to 50. | Diagnostic test | Breast Cancer Patients |
Primary outcome
MAP-BC Evaluation Tool
Time frame: 11 months
This tool was developed to evaluate scar tissues that occured after breast cancer treatments. It quantitatively measures myofascial adhesions. The degree of adhesion is scored for each area at 3 different depth levels (skin, superficial, deep) as a 4-point scale (0: no adhesion - 3: severe adhesion). Axillary scar, breast/mastectomy scar, m. pectoralis region, frontal chest wall, lateral chest wall, axilla and inframammary fold are evaluated separately. Sum of the scores from three levels of each area gives the total score. The maximum score is 63. In Breast cancer patients, the inter-rater reliability of the detection of myofascial adhesions by palpation has been reported good to excellent.
POSAS
Time frame: 11 months
This assesment tool consists of two different scales evaluated by the observer and the patient. Its validity and reliability have been proven for the detection of scar tissue in patients who have undergone breast cancer surgery. The observer scale rates five variables, which include vascularity, pigmentation, thickness, relief, pliability and surface area, between 1-10 points (1:normal skin). The total score ranges from 5 to 50. The Turkish version of POSAS, whose validity and reliability studies were conducted, will be used in our study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 17230080Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc.
- Background: PubMed 15319762Lewit K, Olsanska S. Clinical importance of active scars: abnormal scars as a cause of myofascial pain. J Manipulative Physiol Ther. 2004 Jul-Aug;27(6):399-402. doi: 10.1016/j.jmpt.2004.05.004.
- Background: PubMed 15804318Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Background: PubMed 32772650De Groef A, Van der Gucht E, Dams L, Evenepoel M, Teppers L, Toppet-Hoegars J, De Baets L. The association between upper limb function and variables at the different domains of the international classification of functioning, disability and health in women after breast cancer surgery: a systematic review. Disabil Rehabil. 2022 Apr;44(8):1176-1189. doi: 10.1080/09638288.2020.1800835. Epub 2020 Aug 8.
- Background: PubMed 29580666Seyyah M, Yurdalan SU. Cultural adaptation and validation of Patient and Observer Scar Assessment Scale for Turkish use. Burns. 2018 Aug;44(5):1352-1356. doi: 10.1016/j.burns.2018.02.026. Epub 2018 Mar 24.
- Background: PubMed 28598978De Groef A, Van Kampen M, Vervloesem N, De Geyter S, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. An evaluation tool for myofascial adhesions in patients after breast cancer (MAP-BC evaluation tool): Development and interrater reliability. PLoS One. 2017 Jun 9;12(6):e0179116. doi: 10.1371/journal.pone.0179116. eCollection 2017.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Yeliz Bahar Özdemir principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Upper Extremity Dysfunction, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 3 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 24 Aug 2023. 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 Turkey (Türkiye). 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 Özden Tömek, MD (Turkey: +905343284941, ozden.tomek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAP-BC Evaluation Tool (time frame: 11 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 NCT05923164, 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 24 Aug 2023.