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AzTrials

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Phase 3NCT05646316

Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

A Phase 3 study testing Biospecimen Collection, Diagnostic Imaging Testing and Excisional Biopsy in people with Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, run by NRG Oncology at 60 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, Diagnostic Imaging Testing and Excisional Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
428 participants
Where
60 sitesin 2 countries
Study dates
7 Dec 2022to 31 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration
  • Clinical stage I endometrial cancer based on the following diagnostic workup:
  • History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
  • Patients must speak English, Spanish, or Korean

Who cannot join

  • Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)
  • History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable
  • History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes
  • Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)
  • Patients with severe, active co-morbidity defined as follows:
  • History of patient or provider identified lower extremity lymphedema
Show all 9Show fewer
  • History of patient or provider identified chronic lower extremity swelling
  • History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration
  • History of lower extremity cellulitis within 90 days of registration

Trial locations and contacts

60 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

60 sites in 2 countries

United States55 sites, 41 recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Site Public Contact, 706-721-2388, ga_cares@augusta.edu

    Robert V. Higgins

    Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Gautam G. Rao

    Recruiting

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

    Site Public Contact, 443-643-3010

    Gautam G. Rao

    Recruiting

  • Saint Vincent Healthcare

    Billings, Montana, 59101

    Active, not recruiting

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

    Active, not recruiting

  • Intermountain Health West End Clinic

    Billings, Montana, 59106

    Active, not recruiting

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

    Suspended

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

    Active, not recruiting

  • IU Health North Hospital

    Carmel, Indiana, 46032

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Jessica E. Parker

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Kari L. Ring

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Emily Hinchcliff

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu

    Jayanthi S. Lea

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Jayanthi S. Lea

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Site Public Contact, 800-527-6266, ctoadmin@karmanos.org

    Robert T. Morris

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Site Public Contact, kginnity@med.miami.edu

    Abdulrahman Sinno

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Britt K. Erickson

    Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Robert T. Morris

    Recruiting

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Robert T. Morris

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Jayanthi S. Lea

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Active, not recruiting

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

    Site Public Contact, 713-792-3245

    Joseph A. Lucci

    Recruiting

  • Methodist Willowbrook Hospital

    Houston, Texas, 77070

    Active, not recruiting

  • Houston Methodist West Hospital

    Houston, Texas, 77094

    Active, not recruiting

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Jessica E. Parker

    Recruiting

  • Fred and Pamela Buffett Cancer Center - Kearney

    Kearney, Nebraska, 68845

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Kerry J. Rodabaugh

    Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Site Public Contact, 702-851-4672

    Nicola M. Spirtos

    Recruiting

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Britt K. Erickson

    Recruiting

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Britt K. Erickson

    Recruiting

  • West Jefferson Medical Center

    Marrero, Louisiana, 70072

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Tara Castellano

    Recruiting

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Tara Castellano

    Recruiting

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Tara Castellano

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Tara Castellano

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Tara Castellano

    Recruiting

  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    North Miami, Florida, 33181

    Site Public Contact, kginnity@med.miami.edu

    Abdulrahman Sinno

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Christina Washington

    Recruiting

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Site Public Contact, 402-559-5600

    Kerry J. Rodabaugh

    Recruiting

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

    Active, not recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Kerry J. Rodabaugh

    Recruiting

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

    Suspended

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Britt K. Erickson

    Recruiting

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

    Site Public Contact, 401-274-1122

    Matthew T. Oliver

    Recruiting

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

    Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu

    Jayanthi S. Lea

    Recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Britt K. Erickson

    Recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • Houston Methodist Sugar Land Hospital

    Sugar Land, Texas, 77479

    Active, not recruiting

  • Houston Methodist The Woodlands Hospital

    The Woodlands, Texas, 77385

    Active, not recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Emily Hinchcliff

    Recruiting

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

    Suspended

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

    Suspended

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Britt K. Erickson

    Recruiting

Other trials in United States

South Korea5 sites, 4 recruiting

  • Gachon University Gil Hospital

    Incheon, 405-760

    Site Public Contact, 82-32-460-3213

    Kwang-Beom Lee

    Recruiting

  • Samsung Changwon Hospital

    Seoul, Gyeongsangnam-do, 51353

    Suspended

  • Asan Medical Center

    Seoul, 05505

    Site Public Contact, irbksh@amc.seoul.kr

    Dae-Yeon Kim

    Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273

    Site Public Contact, 82-2-2019-3600

    Jae-Hoon Kim

    Recruiting

  • Ewha Woman's University Mokdong Hospital

    Seoul, 07985

    Site Public Contact, 82 2-2650-5114

    Yun H. Kim

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the rates of lower extremity limb dysfunction (defined as a >= 4-point increase in Gynecologic Cancer Lymphedema Questionnaire [GCLQ] symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy:

Ia. Sentinel lymph node mapping and excision followed by side-specific lymphadenectomy on sides without a sentinel lymph node (SLN) identified according to a National Comprehensive Cancer Network (NCCN) guidelines approved algorithm (Arm 1); Ib. Sentinel lymph node mapping and excision according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy (Arm 2).

SECONDARY OBJECTIVE:

  1. To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

II. To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging.

EXPLORATORY OBJECTIVES:

  1. To compare adjuvant therapy decisions in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

II. To explore the impact of patient characteristics (age, body mass index [BMI], race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy) on the development of lower extremity limb dysfunction - as well as their interaction with lymph node assessment strategies.

III. To evaluate the cost-effectiveness of SLN mapping with or without completion of lymphadenectomy for endometrial cancer.

SAFETY OBJECTIVE:

  1. To compare progression free and overall survival in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes.

ARM 2: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care.

Patients in both arms also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

After completion of study intervention, patients are followed every 3 months for one year and at 18 and 24 months.

Being tested
Biospecimen Collection, Diagnostic Imaging Testing, Excisional Biopsy, Indocyanine Green Solution, Minimally Invasive Surgery
Medical subject headings
Carcinosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Diagnostic Imaging TestingProcedure or surgery

    Also called Diagnostic Imaging, Medical Imaging

    Undergo imaging

  • Excisional BiopsyProcedure or surgery

    Also called Biopsy, Excisional, Excision Biopsy, surgical biopsy

    Undergo sentinel lymph node excision

  • Indocyanine Green SolutionDrug

    Also called IC-GREEN, ICG Solution

    Given via injection

  • Minimally Invasive SurgeryProcedure or surgery

    Also called Minimally-Invasive Surgery, Surgery, Minimally Invasive

    Undergo minimally invasive hysterectomy

  • Pelvic LymphadenectomyProcedure or surgery

    Also called Excision Pelvic Lymph Nodes, Pelvic Lymph Node Dissection

    Undergo pelvic lymphadenectomy

  • Questionnaire AdministrationOther

    Ancillary studies

  • Sentinel Lymph Node MappingProcedure or surgery

    Also called Sentinel Lymph Node Imaging

    Undergo sentinel lymph node mapping

Study groups in NCT05646316
Study groupRoleWhat they receive
Arm 1 (sentinel lymph node mapping)ExperimentalPatients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Diagnostic Imaging Testing; Procedure: Excisional Biopsy; Drug: Indocyanine Green Solution; Procedure: Minimally Invasive Surgery; Procedure: Pelvic Lymphadenectomy; Other: Questionnaire Administration; Procedure: Sentinel Lymph Node Mapping
Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)ExperimentalPatients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Diagnostic Imaging Testing; Procedure: Excisional Biopsy; Drug: Indocyanine Green Solution; Procedure: Minimally Invasive Surgery; Procedure: Pelvic Lymphadenectomy; Other: Questionnaire Administration; Procedure: Sentinel Lymph Node Mapping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of patient-reported lower extremity limb dysfunction

    The primary endpoint is the incidence of patient-reported lower extremity limb dysfunction at 18 months post-hysterectomy after undergoing lymphatic assessment according to a National Comprehensive Cancer Network guideline-based sentinel lymph node (SLN) mapping algorithm with or without completion of lymphadenectomy. The primary endpoint will be assessed using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) questionnaire. Surveys will be performed at enrollment (pre-surgery) and at 3, 6, 9, 12, and 18 months post-surgery. Patient-reported lower extremity limb dysfunction will be defined as an increase in GCLQ symptom score of at least four (4) points from baseline at any time during the 18 months follow-up. The primary null hypothesis will be evaluated with an intent-to-treat chi-squared test, adjusted for stratification factors. Proportional hazards modeling will be used to generate a hazard ratio and 95% confidence limits of Arm 1 versus Arm 2.

    Measured: From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

Secondary outcomes (4)

  1. The incidence of lymphedema by quantifiable lower extremity limb changes

    Patients will undergo circumferential lower extremity limb measures at three locations along each leg. Change will be estimated as measurement at baseline subtracted from measurement at follow-up. This will be assessed in both legs separately.

    Measured: From enrollment and at 3, 6, 9, 12, and 18 months after surgery

  2. Rate of successful bilateral SLN identification

    Will be assessed in both, and only as the time of surgery.

    Measured: At time of surgery

  3. Rate of successful identification of lymph node metastasis

    Will be assessed in both, and only as the time of surgery. The rate of lymph node metastasis identification during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.

    Measured: At time of surgery

  4. Rate of perioperative complications

    Will be assessed in both arms separately, and only as the time of surgery. The rate of perioperative complications during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.

    Measured: At time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2022
  2. Study start7 Dec 2022
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
428 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05646316
Sponsor's protocol ID
NRG-CC010
Other IDs
NCI-2022-05090, NRG-CC010, NRG-CC010, NRG-CC010, UG1CA189867
Status last verified
Aug 2026
First submitted
2 Dec 2022
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biospecimen Collection, Diagnostic Imaging Testing and Excisional Biopsy in people with Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, run by NRG Oncology at 60 sites in 2 countries.

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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, South Korea. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of patient-reported lower extremity limb dysfunction (time frame: From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months). 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 NCT05646316.

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 7 Aug 2026.

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