Breast CancerNCT04170335
Effects of Bariatric Surgery on Breast Density Improvement and Impact on Breast Cancer Risk in Severe Obese Patients
An observational study of Breast Cancer and Morbid Obesity, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Breast cancer is the most common cancer in women in the US, and obese women have a 20% to 40% increase in the risk of developing breast cancer compared with normal-weight women. Bariatric surgery is now considered the first line option for weight loss management in morbidly obese patients with failure of medical… Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Breast Cancer, Morbid Obesity, Bariatric Surgery Candidate
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women older than age 40 and younger than age 74 undergoing primary bariatric surgery selected and consented for elective bariatric surgery will be recruited
Who may be able to join
- women older than age 40 and younger than age 74 who qualify for bariatric surgery (BMI of ≥35 with at least one co-morbid condition), or BMI> 40
Who cannot join
- Patients with previous diagnosis of breast cancer, previous diagnosis of ductal carcinoma in situ (DCIS), previous breast augmentation and previous mastectomy will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Bariatric Surgery on Breast Density Improvement and Its Impact on Breast Cancer Risk in Morbidly Obese Patients
Breast cancer is the most common cancer in women in the US, and obese women have a 20% to 40% increase in the risk of developing breast cancer compared with normal-weight women. Bariatric surgery is now considered the first line option for weight loss management in morbidly obese patients with failure of medical treatment.
There is strong evidence that in early stages of cancer the breast undergoes inflammatory and subsequently density changes that are observable in mammography. The aforementioned alterations have been suggested to be magnified by obesity, potentially due to its pro-inflammatory state. The investigators hypothesized that rapid weight loss following bariatric surgery and henceforth the reduction of inflammatory stress in the breast tissue could potentially have a positive effect in improving breast density and consequently, reducing the risk of breast cancer. In this order of ideas, with this study, the investigators aim to evaluate how breast density is modified after bariatric surgery, and how it impacts the risk of developing breast cancer using The Breast Cancer Surveillance Consortium (BCSC) risk score and calculator in our population.
Read the detailed description
This study is a prospective observational study involving patients selected for elective bariatric surgery. Thirty-five women older than age 40 and younger than age 74 undergoing primary bariatric surgery and having a BMI of ≥35 will be enrolled in this study. Patients with previous diagnosis of breast cancer, previous diagnosis of ductal carcinoma in situ (DCIS), previous breast augmentation and previous mastectomy will be excluded from the study. Patients selected and consented for elective bariatric surgery will be recruited in the Bariatric and Metabolic Institute at CCF, Weston FL and will undergo standard of care and additional measurements before and after surgery as explained below:
- A first mammogram study will be performed between two to four weeks before bariatric surgery, if the patient had a normal digital mammogram performed in the 12 months prior to bariatric surgery, it would be accepted as the first mammogram study. This mammogram is a part of the standard of care screening for this population group. Standard measurements will be assessed including the BI-RADS® breast density score (radiologic assessment of the density of breast tissue by a radiologist who interprets mammograms) and The LIBRA (Laboratory for Individualized Breast Radiodensity Assessment) software.
- A subsequent mammogram study (also part of the standard of care screening for this population group) will be performed one year after the date of the bariatric procedure, and standard measurements will be re-assessed, including re-stratification of BI-RADS and LIBRA.
- The mammogram results will be obtained through medical records. If a patient had done a mammogram at a non Cleveland Clinic facility, the investigator will ask them to sign an authorization form to allow Cleveland Clinic Florida to request for their mammography study from the previous year to the outside facility where it was done.
- Inflammatory markers including CRP, IGF1, IL6, TNF, will also be measured between two to four weeks before bariatric surgery as a part of the pre-surgical blood work up and, one year after the date of the bariatric procedure.
The inflammatory markers will be collected and processed as follows:
- CRP will be collected in a test tube containing lithium heparin (Green container). It will be delivered between two hours of collection to our institutional laboratory for processing.
- IGF1 will be collected in a test tube containing SST (Gold container). It will be delivered refrigerated between two hours of collection to our institutional laboratory for processing.
- IL6 will be collected in a test tube containing SST (Gold container). It will be delivered on ice ASAP upon collection to our institutional laboratory for processing.
- TNF will be collected in a test tube containing SST (Gold container). It will be delivered between two hours of collection to our institutional laboratory for processing.
- Biometric measurements will be assessed before surgery and at the time of the subsequent mammogram (one year after surgery). It will include weight, height, BMI and Waist circumference.
- Basic demographics and comorbidities (Diabetes Mellitus, Hypertension, pulmonary hypertension, sleep apnea, dyslipidemia, cardiovascular disease, chronic kidney disease, smoking status, alcohol use and hormonal replacement history) will also be analyzed.
- Conditions
- Breast Cancer, Morbid Obesity, Bariatric Surgery Candidate
- Being tested
- Bariatric surgery
- Keywords
- Breast cancer, Morbid obesity, Bariatric surgery, Mammography, Inflammatory markers
- Medical subject headings
- Breast Neoplasms, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Patients selected and consented for elective bariatric surgery will undergo standard of care preoperative mammogram, as well as inflammatory markers measurements and breast cancer risk score calculation. Post bariatric surgery the patients will have follow up mammogram, inflammatory markers, and breast cancer risk score calculation
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery group | Women older than age 40 and younger than age 74 undergoing primary bariatric surgery and having a BMI of ≥35 will be enrolled in this study. Pre operative and postoperative mammograms, inflammatory markers and breast cancer risk scores will be compared. Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammogram findings before and after intervention: BI-RADS
Mammogram findings according to the BI-RADS® breast density score (radiologic assessment of the density of breast tissue
Measured: 12 months
Mammogram findings before and after intervention:LIBRA
Mammogram findings according to the The LIBRA (Laboratory for Individualized Breast Radiodensity Assessment) software
Measured: 12 months
Inflammatory markers before and after intervention: C-reactive protein
Serum measurements of Inflammatory marker including C-reactive protein (CRP)
Measured: 12 months
Inflammatory markers before and after intervention: Interleukin-6
Serum measurements of Inflammatory marker including Interleukin-6 (IL-6)
Measured: 12 months
Inflammatory markers before and after intervention: Insulin Growth Factor-1 (IGF-1)
Serum measurements of Inflammatory marker including Insulin Growth Factor-1 (IGF-1)
Measured: 12 months
Inflammatory markers before and after intervention: Tumor Necrosis
Serum measurements of Inflammatory marker including Tumor Necrosis Factor (TNF)
Measured: 12 months
Breast cancer risk calculation
Breast cancer risk calculation using The Breast Cancer Surveillance Consortium (BCSC) Risk Calculator
Measured: 12 months
Biometric measurements: weight
Weight will be assessed before surgery and at one year after surgery.
Measured: 12 months
Biometric measurements: Height
Height will be assessed before surgery and at one year after surgery.
Measured: 12 months
Biometric measurements: Body mass index
Body mass index will be assessed before surgery and at one year after surgery.
Measured: 12 months
Biometric measurements: Waist circumference.
Waist circumference. will be assessed before surgery and at one year after surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start22 Feb 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: No inclusion
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.
- More trials run by The Cleveland ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Rosenthal, The Cleveland Clinic
- Investigators
- Raul Rosenthal, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170335
- Sponsor's protocol ID
- FLA 18-057
- Status last verified
- Sep 2023
- First submitted
- 18 Nov 2019
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steele CB, Thomas CC, Henley SJ, Massetti GM, Galuska DA, Agurs-Collins T, Puckett M, Richardson LC. Vital Signs: Trends in Incidence of Cancers Associated with Overweight and Obesity - United States, 2005-2014. MMWR Morb Mortal Wkly Rep. 2017 Oct 3;66(39):1052-1058. doi: 10.15585/mmwr.mm6639e1.
PubMed 28981482Vaysse C, Lomo J, Garred O, Fjeldheim F, Lofteroed T, Schlichting E, McTiernan A, Frydenberg H, Husoy A, Lundgren S, Fagerland MW, Richardsen E, Wist EA, Muller C, Thune I. Erratum: Inflammation of mammary adipose tissue occurs in overweight and obese patients exhibiting early-stage breast cancer. NPJ Breast Cancer. 2017 Sep 5;3:35. doi: 10.1038/s41523-017-0030-x. eCollection 2017.
PubMed 28884144Sun X, Glynn DJ, Hodson LJ, Huo C, Britt K, Thompson EW, Woolford L, Evdokiou A, Pollard JW, Robertson SA, Ingman WV. CCL2-driven inflammation increases mammary gland stromal density and cancer susceptibility in a transgenic mouse model. Breast Cancer Res. 2017 Jan 11;19(1):4. doi: 10.1186/s13058-016-0796-z.
PubMed 28077158McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jun;15(6):1159-69. doi: 10.1158/1055-9965.EPI-06-0034.
PubMed 16775176Williams AD, So A, Synnestvedt M, Tewksbury CM, Kontos D, Hsiehm MK, Pantalone L, Conant EF, Schnall M, Dumon K, Williams N, Tchou J. Mammographic breast density decreases after bariatric surgery. Breast Cancer Res Treat. 2017 Oct;165(3):565-572. doi: 10.1007/s10549-017-4361-y. Epub 2017 Jun 28.
PubMed 28660430Keller BM, Chen J, Daye D, Conant EF, Kontos D. Preliminary evaluation of the publicly available Laboratory for Breast Radiodensity Assessment (LIBRA) software tool: comparison of fully automated area and volumetric density measures in a case-control study with digital mammography. Breast Cancer Res. 2015 Aug 25;17:117. doi: 10.1186/s13058-015-0626-8.
PubMed 26303303Schauer DP, Feigelson HS, Koebnick C, Caan B, Weinmann S, Leonard AC, Powers JD, Yenumula PR, Arterburn DE. Bariatric Surgery and the Risk of Cancer in a Large Multisite Cohort. Ann Surg. 2019 Jan;269(1):95-101. doi: 10.1097/SLA.0000000000002525.
PubMed 28938270
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on Breast Density Improvement and Its Impact on Breast Cancer Risk in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT04170335
- Acronym / sponsor ID
- FLA 18-057
- Conditions
- Breast Cancer, Morbid Obesity, Bariatric Surgery Candidate
- Keywords
- Breast cancer, Morbid obesity, Bariatric surgery, Mammography, Inflammatory markers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Nov 2019 (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.
Breast cancer is the most common cancer in women in the US, and obese women have a 20% to 40% increase in the risk of developing breast cancer compared with normal-weight women. Bariatric surgery is now considered the first line option for weight loss management in morbidly obese patients with failure of medical treatment.
There is strong evidence that in early stages of cancer the breast undergoes inflammatory and subsequently density changes that are observable in mammography. The aforementioned alterations have been suggested to be magnified by obesity, potentially due to its pro-inflammatory state. The investigators hypothesized that rapid weight loss following bariatric surgery and henceforth the reduction of inflammatory stress in the breast tissue could potentially have a positive effect in improving breast density and consequently, reducing the risk of breast cancer. In this order of ideas, with this study, the investigators aim to evaluate how breast density is modified after bariatric surgery, and how it impacts the risk of developing breast cancer using The Breast Cancer Surveillance Consortium (BCSC) risk score and calculator in our population.
Detailed description
This study is a prospective observational study involving patients selected for elective bariatric surgery. Thirty-five women older than age 40 and younger than age 74 undergoing primary bariatric surgery and having a BMI of ≥35 will be enrolled in this study. Patients with previous diagnosis of breast cancer, previous diagnosis of ductal carcinoma in situ (DCIS), previous breast augmentation and previous mastectomy will be excluded from the study. Patients selected and consented for elective bariatric surgery will be recruited in the Bariatric and Metabolic Institute at CCF, Weston FL and will undergo standard of care and additional measurements before and after surgery as explained below:
- A first mammogram study will be performed between two to four weeks before bariatric surgery, if the patient had a normal digital mammogram performed in the 12 months prior to bariatric surgery, it would be accepted as the first mammogram study. This mammogram is a part of the standard of care screening for this population group. Standard measurements will be assessed including the BI-RADS® breast density score (radiologic assessment of the density of breast tissue by a radiologist who interprets mammograms) and The LIBRA (Laboratory for Individualized Breast Radiodensity Assessment) software.
- A subsequent mammogram study (also part of the standard of care screening for this population group) will be performed one year after the date of the bariatric procedure, and standard measurements will be re-assessed, including re-stratification of BI-RADS and LIBRA.
- The mammogram results will be obtained through medical records. If a patient had done a mammogram at a non Cleveland Clinic facility, the investigator will ask them to sign an authorization form to allow Cleveland Clinic Florida to request for their mammography study from the previous year to the outside facility where it was done.
- Inflammatory markers including CRP, IGF1, IL6, TNF, will also be measured between two to four weeks before bariatric surgery as a part of the pre-surgical blood work up and, one year after the date of the bariatric procedure.
The inflammatory markers will be collected and processed as follows:
- CRP will be collected in a test tube containing lithium heparin (Green container). It will be delivered between two hours of collection to our institutional laboratory for processing.
- IGF1 will be collected in a test tube containing SST (Gold container). It will be delivered refrigerated between two hours of collection to our institutional laboratory for processing.
- IL6 will be collected in a test tube containing SST (Gold container). It will be delivered on ice ASAP upon collection to our institutional laboratory for processing.
- TNF will be collected in a test tube containing SST (Gold container). It will be delivered between two hours of collection to our institutional laboratory for processing.
- Biometric measurements will be assessed before surgery and at the time of the subsequent mammogram (one year after surgery). It will include weight, height, BMI and Waist circumference.
- Basic demographics and comorbidities (Diabetes Mellitus, Hypertension, pulmonary hypertension, sleep apnea, dyslipidemia, cardiovascular disease, chronic kidney disease, smoking status, alcohol use and hormonal replacement history) will also be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery group | – | Procedure: Bariatric surgeryWomen older than age 40 and younger than age 74 undergoing primary bariatric surgery and having a BMI of ≥35 will be enrolled in this study. Pre operative and postoperative mammograms, inflammatory markers and breast cancer risk scores will be compared. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women older than age 40 and younger than age 74 undergoing primary bariatric surgery selected and consented for elective bariatric surgery will be recruited
Key inclusion criteria (1 listed)
- women older than age 40 and younger than age 74 who qualify for bariatric surgery (BMI of ≥35 with at least one co-morbid condition), or BMI> 40
Key exclusion criteria (1 listed)
- Patients with previous diagnosis of breast cancer, previous diagnosis of ductal carcinoma in situ (DCIS), previous breast augmentation and previous mastectomy will be excluded from the study
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 |
|---|---|---|
| Bariatric surgeryPatients selected and consented for elective bariatric surgery will undergo standard of care preoperative mammogram, as well as inflammatory markers measurements and breast cancer risk score calculation. Post bariatric surgery the patients will have follow up mammogram, inflammatory markers, and breast cancer risk score calculation | Procedure or surgery | Bariatric surgery group |
Primary outcome
Mammogram findings before and after intervention: BI-RADS
Time frame: 12 months
Mammogram findings according to the BI-RADS® breast density score (radiologic assessment of the density of breast tissue
Mammogram findings before and after intervention:LIBRA
Time frame: 12 months
Mammogram findings according to the The LIBRA (Laboratory for Individualized Breast Radiodensity Assessment) software
Inflammatory markers before and after intervention: C-reactive protein
Time frame: 12 months
Serum measurements of Inflammatory marker including C-reactive protein (CRP)
Inflammatory markers before and after intervention: Interleukin-6
Time frame: 12 months
Serum measurements of Inflammatory marker including Interleukin-6 (IL-6)
Inflammatory markers before and after intervention: Insulin Growth Factor-1 (IGF-1)
Time frame: 12 months
Serum measurements of Inflammatory marker including Insulin Growth Factor-1 (IGF-1)
Inflammatory markers before and after intervention: Tumor Necrosis
Time frame: 12 months
Serum measurements of Inflammatory marker including Tumor Necrosis Factor (TNF)
Breast cancer risk calculation
Time frame: 12 months
Breast cancer risk calculation using The Breast Cancer Surveillance Consortium (BCSC) Risk Calculator
Biometric measurements: weight
Time frame: 12 months
Weight will be assessed before surgery and at one year after surgery.
Biometric measurements: Height
Time frame: 12 months
Height will be assessed before surgery and at one year after surgery.
Biometric measurements: Body mass index
Time frame: 12 months
Body mass index will be assessed before surgery and at one year after surgery.
Biometric measurements: Waist circumference.
Time frame: 12 months
Waist circumference. will be assessed before surgery and at one year after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Background: PubMed 28981482Steele CB, Thomas CC, Henley SJ, Massetti GM, Galuska DA, Agurs-Collins T, Puckett M, Richardson LC. Vital Signs: Trends in Incidence of Cancers Associated with Overweight and Obesity - United States, 2005-2014. MMWR Morb Mortal Wkly Rep. 2017 Oct 3;66(39):1052-1058. doi: 10.15585/mmwr.mm6639e1.
- Background: PubMed 28884144Vaysse C, Lomo J, Garred O, Fjeldheim F, Lofteroed T, Schlichting E, McTiernan A, Frydenberg H, Husoy A, Lundgren S, Fagerland MW, Richardsen E, Wist EA, Muller C, Thune I. Erratum: Inflammation of mammary adipose tissue occurs in overweight and obese patients exhibiting early-stage breast cancer. NPJ Breast Cancer. 2017 Sep 5;3:35. doi: 10.1038/s41523-017-0030-x. eCollection 2017.
- Background: PubMed 28077158Sun X, Glynn DJ, Hodson LJ, Huo C, Britt K, Thompson EW, Woolford L, Evdokiou A, Pollard JW, Robertson SA, Ingman WV. CCL2-driven inflammation increases mammary gland stromal density and cancer susceptibility in a transgenic mouse model. Breast Cancer Res. 2017 Jan 11;19(1):4. doi: 10.1186/s13058-016-0796-z.
- Background: PubMed 16775176McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jun;15(6):1159-69. doi: 10.1158/1055-9965.EPI-06-0034.
- Background: PubMed 28660430Williams AD, So A, Synnestvedt M, Tewksbury CM, Kontos D, Hsiehm MK, Pantalone L, Conant EF, Schnall M, Dumon K, Williams N, Tchou J. Mammographic breast density decreases after bariatric surgery. Breast Cancer Res Treat. 2017 Oct;165(3):565-572. doi: 10.1007/s10549-017-4361-y. Epub 2017 Jun 28.
- Background: PubMed 26303303Keller BM, Chen J, Daye D, Conant EF, Kontos D. Preliminary evaluation of the publicly available Laboratory for Breast Radiodensity Assessment (LIBRA) software tool: comparison of fully automated area and volumetric density measures in a case-control study with digital mammography. Breast Cancer Res. 2015 Aug 25;17:117. doi: 10.1186/s13058-015-0626-8.
- Background: PubMed 28938270Schauer DP, Feigelson HS, Koebnick C, Caan B, Weinmann S, Leonard AC, Powers JD, Yenumula PR, Arterburn DE. Bariatric Surgery and the Risk of Cancer in a Large Multisite Cohort. Ann Surg. 2019 Jan;269(1):95-101. doi: 10.1097/SLA.0000000000002525.
- 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.
Raul Rosenthal, MD principal investigator
Cleveland Clinic Florida
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 Morbid Obesity, run by The Cleveland Clinic at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 15 Sep 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mammogram findings before and after intervention: BI-RADS (time frame: 12 months). The study lists 11 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 NCT04170335, 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 15 Sep 2023.