Breast CancerLIBREASTNCT04817813
Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study
An observational study of Breast Cancer and Liver Metastases, run by Hospital Miguel Servet at 1 site in Spain.
Trial summary
Breast cancer ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in females worldwide. Approximately, 20-30% of breast cancer cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastasis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer, Liver Metastases, Surgery
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2021to 31 Jul 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients operated on in the participating European centers with breast cancer liver metastases during the study period (between January 1st 2010 and December 31st 2015) and that meet the inclusion criteria.
Who may be able to join
- Patients ≥ 18 year old.
- Scheduled surgery for breast cancer liver metastases between January 1st 2010 and December 31st 2015
- American Society of Anesthesiologists (ASA) score I-III.
- They have signed the informed consent.
Who cannot join
- Patients under 18 year old.
- ASA ≥ IV.
- Urgent surgery.
- Patients who have not signed the informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Mario Serradilla Martín
Zaragoza, 50008
Mario Serradilla Martín, MD FACS, marioserradilla@hotmail.com
About this study
Official title: LIBREAST STUDY: Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study
Breast cancer ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in females worldwide. Approximately, 20-30% of breast cancer cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastasis. The proper indication for surgical treatment of breast cancer liver metastasis is still a matter of discussion. Surgery is becoming more practical and effective than conservative treatment in improving the outcomes of patients with breast cancer liver metastasis and liver metastasis surgery is included in an onco- surgical strategy.
Read the detailed description
Breast cancer ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in female's worldwide . Approximately, 20-30% of breast cancer (BC) cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastases (BCLM) . The presence of liver metastasis has markedly worsened the prognosis of patients, and the median survival was reported to be 3.8-29 months.
Metastatic breast cancer is considered to be a disseminated disease and many oncologists remain reluctant to include surgery within the multimodal treatment strategy of these patients . Although systemic treatments can achieve approximately 60% of responses in breast cancer recurrence, long-term survival is exceptional only with medical treatment . Without liver resection, the average survival reported after the first onset of liver metastases is distributed over a range from 1 to 15 months. Surgery is becoming more functional and effective than conservative treatment in improving the poor outcomes of patients with BCLM . However, there is no generally acknowledged set of standards for identifying candidates who will benefit from surgery. The proper indication for surgical treatment is still a matter of discussion; surgical resection should be assessed when the following premises are met: low surgical risk, low metastasis number, complete macroscopic liver removal, absence of proven extrahepatic disease by positron emission tomography and computed tomography, objective response to chemotherapy before surgery, and long disease-free interval. Breast cancer liver metastasis surgery (BCLMS) is included in an onco-surgical strategy.
Most of the published series of patients with liver metastases of breast cancer who have undergone surgery come from a single center or few centers and there are hardly any long-term results, so we consider necessary to carry out a multicenter review of patients who underwent surgery in high volume centers across Europe belonging to the European-African Hepato-Pancreato-Biliary Association (E-AHPBA) to asses survival and disease-free survival and to determine which patients may benefit from surgery.
This retrospective multicenter cohort study in centers performing BCLMS aims to provide an assessment of the outcomes across E-AHPBA centers.
- Conditions
- Breast Cancer, Liver Metastases, Surgery
- Keywords
- Breast cancer, Liver metastases, Hepatic surgery
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival and disease-free survival at 1st year.
Disease-free time and survival at 1st year.
Measured: 1 year.
Survival and disease-free survival at 3th year.
Disease-free time and survival at 3th year.
Measured: 3 years.
Survival and disease-free survival at 5th year.
Disease-free time and survival at 5th year.
Measured: 5 years.
Secondary outcomes (17)
Preoperative details-Tumor TNM
Stage
Measured: 5 years.
Preoperative details- Dysplasia grade
Low-Moderate- High
Measured: 5 years.
Preoperative details- Tumor subtypes
Yes/No of Luminal A/Luminal B/ HER2+/Triple negative-basal like
Measured: 5 years.
Preoperative details- Location of breast cancer
Breast Quadrant
Measured: 5 years.
Preoperative details- Segment location
Segment 1 to 8
Measured: 5 years.
Preoperative details- Number of liver metastasis
Number
Measured: 5 years.
Intra-operative events
Satava's Classification
Measured: Surgery date.
Nº metastasis intraoperatively
Number
Measured: Surgery date.
Post-operative curse- Re-hospitalization cause
Cause of re-hospitalization
Measured: 30 days.
Post-operative curse- Complications
Clavien- Dindo Classification
Measured: 30 days.
Post-operative curse- ICU admission length of stay
Days
Measured: 30 days.
Histopathological details- Ki67
Percent
Measured: 30 days.
Histopathological details- Resection status
R0-R1-R2
Measured: 30 days.
Histopathological details- Nº of lesions
Number
Measured: 30 days.
Follow up- Adjuvant systemic treatment
Yes/No of Chemotherapy, Hormonetherapy, AntiHER2Therapy, Antiangiogenics
Measured: 5 years.
Follow up- Liver metastasis relapse
Location of relapse
Measured: 5 years.
Follow up- Date of death
Date
Measured: 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start15 Mar 2021 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Association of Surgeons (AEC)
- Responsible party
- Principal investigator, Mario Serradilla, MD, FACS, Hospital Miguel Servet
- Investigators
- Mario Serradilla Martín, MD FACS, Principal investigator, Zaragoza, Spain. Miguel Servet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817813
- Sponsor's protocol ID
- PI20/596
- Acronym
- LIBREAST
- Status last verified
- Mar 2021
- First submitted
- 5 Feb 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He X, Zhang Q, Feng Y, Li Z, Pan Q, Zhao Y, Zhu W, Zhang N, Zhou J, Wang L, Wang M, Liu Z, Zhu H, Shao Z, Wang L. Resection of liver metastases from breast cancer: a multicentre analysis. Clin Transl Oncol. 2020 Apr;22(4):512-521. doi: 10.1007/s12094-019-02155-2. Epub 2019 Jun 22.
PubMed 31230220Chen QF, Huang T, Shen L, Wu P, Huang ZL, Li W. Prognostic factors and survival according to tumor subtype in newly diagnosed breast cancer with liver metastases: A competing risk analysis. Mol Clin Oncol. 2019 Sep;11(3):259-269. doi: 10.3892/mco.2019.1890. Epub 2019 Jul 1.
PubMed 31396386Sadot E, Lee SY, Sofocleous CT, Solomon SB, Gonen M, Kingham TP, Allen PJ, DeMatteo RP, Jarnagin WR, Hudis CA, D'Angelica MI. Hepatic Resection or Ablation for Isolated Breast Cancer Liver Metastasis: A Case-control Study With Comparison to Medically Treated Patients. Ann Surg. 2016 Jul;264(1):147-154. doi: 10.1097/SLA.0000000000001371.
PubMed 26445472Margonis GA, Buettner S, Sasaki K, Kim Y, Ratti F, Russolillo N, Ferrero A, Berger N, Gamblin TC, Poultsides G, Tran T, Postlewait LM, Maithel S, Michaels AD, Bauer TW, Marques H, Barroso E, Aldrighetti L, Pawlik TM. The role of liver-directed surgery in patients with hepatic metastasis from primary breast cancer: a multi-institutional analysis. HPB (Oxford). 2016 Aug;18(8):700-5. doi: 10.1016/j.hpb.2016.05.014. Epub 2016 Jun 29.
PubMed 27485066Treska V, Cerna M, Kydlicek T, Treskova I. Prognostic factors of breast cancer liver metastasis surgery. Arch Med Sci. 2015 Jun 19;11(3):683-5. doi: 10.5114/aoms.2015.52376. No abstract available.
PubMed 26170865Diaz R, Santaballa A, Munarriz B, Calderero V. Hepatic resection in breast cancer metastases: should it be considered standard treatment? Breast. 2004 Jun;13(3):254-8. doi: 10.1016/j.breast.2003.11.001.
PubMed 15177433Ramia JM, Villar J, Villegas T, Muffak K, Garrote D, Ferron JA. [Surgical treatment of liver metastases from breast cancer]. Cir Esp. 2005 Nov;78(5):318-22. doi: 10.1016/s0009-739x(05)70942-8. Spanish.
PubMed 16420849Figueras J, Gonzalez HD. [Surgical treatment of breast cancer liver metastasis. The great assignment awaiting Spanish hepatic surgery]. Cir Esp. 2008 Nov;84(5):239-40. doi: 10.1016/s0009-739x(08)75913-x. No abstract available. Spanish.
PubMed 19080906Roffman CE, Buchanan J, Allison GT. Charlson Comorbidities Index. J Physiother. 2016 Jul;62(3):171. doi: 10.1016/j.jphys.2016.05.008. Epub 2016 Jun 11. No abstract available.
PubMed 27298055Satava RM. Identification and reduction of surgical error using simulation. Minim Invasive Ther Allied Technol. 2005;14(4):257-61. doi: 10.1080/13645700500274112.
PubMed 16754172Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542The Royal College of Pathologists. Standards and Minimum Datasets for Reporting Cancers Minimum dataset for the histopathological reporting of pancreatic, ampulla of Vater and bile duct carcinoma. London R Coll Pathol. 2002.
Rahbari NN, Garden OJ, Padbury R, Maddern G, Koch M, Hugh TJ, Fan ST, Nimura Y, Figueras J, Vauthey JN, Rees M, Adam R, Dematteo RP, Greig P, Usatoff V, Banting S, Nagino M, Capussotti L, Yokoyama Y, Brooke-Smith M, Crawford M, Christophi C, Makuuchi M, Buchler MW, Weitz J. Post-hepatectomy haemorrhage: a definition and grading by the International Study Group of Liver Surgery (ISGLS). HPB (Oxford). 2011 Aug;13(8):528-35. doi: 10.1111/j.1477-2574.2011.00319.x. Epub 2011 Jun 7.
PubMed 21762295Brooke-Smith M, Figueras J, Ullah S, Rees M, Vauthey JN, Hugh TJ, Garden OJ, Fan ST, Crawford M, Makuuchi M, Yokoyama Y, Buchler M, Weitz J, Padbury R. Prospective evaluation of the International Study Group for Liver Surgery definition of bile leak after a liver resection and the role of routine operative drainage: an international multicentre study. HPB (Oxford). 2015 Jan;17(1):46-51. doi: 10.1111/hpb.12322. Epub 2014 Jul 24.
PubMed 25059275Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.
PubMed 21236455
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIBREAST STUDY: Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study
- ClinicalTrials.gov ID
- NCT04817813
- Acronym / sponsor ID
- LIBREAST / PI20/596
- Conditions
- Breast Cancer, Liver Metastases, Surgery
- Keywords
- Breast cancer, Liver metastases, Hepatic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Collaborators
- Spanish Association of Surgeons (AEC)
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 26 Mar 2021 (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 ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in females worldwide. Approximately, 20-30% of breast cancer cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastasis. The proper indication for surgical treatment of breast cancer liver metastasis is still a matter of discussion. Surgery is becoming more practical and effective than conservative treatment in improving the outcomes of patients with breast cancer liver metastasis and liver metastasis surgery is included in an onco- surgical strategy.
Detailed description
Breast cancer ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in female's worldwide . Approximately, 20-30% of breast cancer (BC) cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastases (BCLM) . The presence of liver metastasis has markedly worsened the prognosis of patients, and the median survival was reported to be 3.8-29 months.
Metastatic breast cancer is considered to be a disseminated disease and many oncologists remain reluctant to include surgery within the multimodal treatment strategy of these patients . Although systemic treatments can achieve approximately 60% of responses in breast cancer recurrence, long-term survival is exceptional only with medical treatment . Without liver resection, the average survival reported after the first onset of liver metastases is distributed over a range from 1 to 15 months. Surgery is becoming more functional and effective than conservative treatment in improving the poor outcomes of patients with BCLM . However, there is no generally acknowledged set of standards for identifying candidates who will benefit from surgery. The proper indication for surgical treatment is still a matter of discussion; surgical resection should be assessed when the following premises are met: low surgical risk, low metastasis number, complete macroscopic liver removal, absence of proven extrahepatic disease by positron emission tomography and computed tomography, objective response to chemotherapy before surgery, and long disease-free interval. Breast cancer liver metastasis surgery (BCLMS) is included in an onco-surgical strategy.
Most of the published series of patients with liver metastases of breast cancer who have undergone surgery come from a single center or few centers and there are hardly any long-term results, so we consider necessary to carry out a multicenter review of patients who underwent surgery in high volume centers across Europe belonging to the European-African Hepato-Pancreato-Biliary Association (E-AHPBA) to asses survival and disease-free survival and to determine which patients may benefit from surgery.
This retrospective multicenter cohort study in centers performing BCLMS aims to provide an assessment of the outcomes across E-AHPBA centers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients operated on in the participating European centers with breast cancer liver metastases during the study period (between January 1st 2010 and December 31st 2015) and that meet the inclusion criteria.
Key inclusion criteria (4 listed)
- Patients ≥ 18 year old.
- Scheduled surgery for breast cancer liver metastases between January 1st 2010 and December 31st 2015
- American Society of Anesthesiologists (ASA) score I-III.
- They have signed the informed consent.
Key exclusion criteria (4 listed)
- Patients under 18 year old.
- ASA ≥ IV.
- Urgent surgery.
- Patients who have not signed the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival and disease-free survival at 1st year.
Time frame: 1 year.
Disease-free time and survival at 1st year.
Survival and disease-free survival at 3th year.
Time frame: 3 years.
Disease-free time and survival at 3th year.
Survival and disease-free survival at 5th year.
Time frame: 5 years.
Disease-free time and survival at 5th year.
17 secondary outcomes
Preoperative details-Tumor TNM
Time frame: 5 years.
Preoperative details- Dysplasia grade
Time frame: 5 years.
Preoperative details- Tumor subtypes
Time frame: 5 years.
Preoperative details- Location of breast cancer
Time frame: 5 years.
Preoperative details- Segment location
Time frame: 5 years.
Preoperative details- Number of liver metastasis
Time frame: 5 years.
Intra-operative events
Time frame: Surgery date.
Nº metastasis intraoperatively
Time frame: Surgery date.
Post-operative curse- Re-hospitalization cause
Time frame: 30 days.
Post-operative curse- Complications
Time frame: 30 days.
Post-operative curse- ICU admission length of stay
Time frame: 30 days.
Histopathological details- Ki67
Time frame: 30 days.
Histopathological details- Resection status
Time frame: 30 days.
Histopathological details- Nº of lesions
Time frame: 30 days.
Follow up- Adjuvant systemic treatment
Time frame: 5 years.
Follow up- Liver metastasis relapse
Time frame: 5 years.
Follow up- Date of death
Time frame: 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Results publication: PubMed 31230220He X, Zhang Q, Feng Y, Li Z, Pan Q, Zhao Y, Zhu W, Zhang N, Zhou J, Wang L, Wang M, Liu Z, Zhu H, Shao Z, Wang L. Resection of liver metastases from breast cancer: a multicentre analysis. Clin Transl Oncol. 2020 Apr;22(4):512-521. doi: 10.1007/s12094-019-02155-2. Epub 2019 Jun 22.
- Results publication: PubMed 31396386Chen QF, Huang T, Shen L, Wu P, Huang ZL, Li W. Prognostic factors and survival according to tumor subtype in newly diagnosed breast cancer with liver metastases: A competing risk analysis. Mol Clin Oncol. 2019 Sep;11(3):259-269. doi: 10.3892/mco.2019.1890. Epub 2019 Jul 1.
- Results publication: PubMed 26445472Sadot E, Lee SY, Sofocleous CT, Solomon SB, Gonen M, Kingham TP, Allen PJ, DeMatteo RP, Jarnagin WR, Hudis CA, D'Angelica MI. Hepatic Resection or Ablation for Isolated Breast Cancer Liver Metastasis: A Case-control Study With Comparison to Medically Treated Patients. Ann Surg. 2016 Jul;264(1):147-154. doi: 10.1097/SLA.0000000000001371.
- Results publication: PubMed 27485066Margonis GA, Buettner S, Sasaki K, Kim Y, Ratti F, Russolillo N, Ferrero A, Berger N, Gamblin TC, Poultsides G, Tran T, Postlewait LM, Maithel S, Michaels AD, Bauer TW, Marques H, Barroso E, Aldrighetti L, Pawlik TM. The role of liver-directed surgery in patients with hepatic metastasis from primary breast cancer: a multi-institutional analysis. HPB (Oxford). 2016 Aug;18(8):700-5. doi: 10.1016/j.hpb.2016.05.014. Epub 2016 Jun 29.
- Results publication: PubMed 26170865Treska V, Cerna M, Kydlicek T, Treskova I. Prognostic factors of breast cancer liver metastasis surgery. Arch Med Sci. 2015 Jun 19;11(3):683-5. doi: 10.5114/aoms.2015.52376. No abstract available.
- Results publication: PubMed 15177433Diaz R, Santaballa A, Munarriz B, Calderero V. Hepatic resection in breast cancer metastases: should it be considered standard treatment? Breast. 2004 Jun;13(3):254-8. doi: 10.1016/j.breast.2003.11.001.
- Results publication: PubMed 16420849Ramia JM, Villar J, Villegas T, Muffak K, Garrote D, Ferron JA. [Surgical treatment of liver metastases from breast cancer]. Cir Esp. 2005 Nov;78(5):318-22. doi: 10.1016/s0009-739x(05)70942-8. Spanish.
- Results publication: PubMed 19080906Figueras J, Gonzalez HD. [Surgical treatment of breast cancer liver metastasis. The great assignment awaiting Spanish hepatic surgery]. Cir Esp. 2008 Nov;84(5):239-40. doi: 10.1016/s0009-739x(08)75913-x. No abstract available. Spanish.
- Results publication: PubMed 27298055Roffman CE, Buchanan J, Allison GT. Charlson Comorbidities Index. J Physiother. 2016 Jul;62(3):171. doi: 10.1016/j.jphys.2016.05.008. Epub 2016 Jun 11. No abstract available.
- Results publication: PubMed 16754172Satava RM. Identification and reduction of surgical error using simulation. Minim Invasive Ther Allied Technol. 2005;14(4):257-61. doi: 10.1080/13645700500274112.
- Results publication: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Results publicationThe Royal College of Pathologists. Standards and Minimum Datasets for Reporting Cancers Minimum dataset for the histopathological reporting of pancreatic, ampulla of Vater and bile duct carcinoma. London R Coll Pathol. 2002.
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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.
Mario Serradilla Martín, MD FACS principal investigator
Zaragoza, Spain. Miguel Servet University Hospital
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 Liver Metastases, run by Hospital Miguel Servet at 1 site in Spain.
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 4 inclusion and 4 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 26 Mar 2021. 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 Spain. 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?
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?
Survival and disease-free survival at 1st year. (time frame: 1 year.). The study lists 3 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 NCT04817813, which also lists 16 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 26 Mar 2021.