Therapy Related Myelodysplastic Syndrome and Therapy Related Acute Myeloid LeukemiaNCT03894852
SRSF2 Gene Mutation in Patients With t-MDS/AML
An observational study of Therapy Related Myelodysplastic Syndrome and Therapy Related Acute Myeloid Leukemia, run by Zeinab Albadry Mohammed Zahran at 2 sites in Egypt.
Trial summary
To detect SRSF2 gene mutation by polymerase chain reaction (PCR) in the two types of t-MDS/AML which recognized in the WHO classification. Association between SRSF2 gene mutation and the presence of other cytogenetic abnormalities in the two types of t-MDS/AML which recognized in the WHO classification, e.g. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Therapy Related Myelodysplastic Syndrome and Therapy Related Acute Myeloid Leukemia
- What is being tested?
- PCR and cytogenetics
- How many people
- 139 participants
- Where
- 2 sitesEgypt
- Study dates
- 2 Jun 2019to 29 Apr 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Cases diagnosed therapy related MDS/AML admitted to department of Clinical Pathology, in the south Egypt cancer institute and Assiut University Hospital.
Who may be able to join
- Patients with myelodysplastic syndromes (MDS), who fulfill the WHO criteria.
- Patients with acute myeloid leukemia (AML), who fulfill the WHO criteria.
- Patients must start therapy (cytotoxic agents and/or ionizing radiotherapy) before beginning of the study, with a documented history of a benign or malignant condition for which they had received therapy prior to the diagnosis of MDS or AML.
Who cannot join
- Patients not fulfill the WHO criteria for diagnosis of MDS and AML.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: SRSF2 Gene Mutation in Patients With Therapy Related Myelodysplastic Syndromes / Acute Myeloid Leukemia
- To detect SRSF2 gene mutation by polymerase chain reaction (PCR) in the two types of t-MDS/AML which recognized in the WHO classification.
- Association between SRSF2 gene mutation and the presence of other cytogenetic abnormalities in the two types of t-MDS/AML which recognized in the WHO classification, e.g. (Loss of chromosome 7 or del(7q), del(5q), isochromosome 17q, recurrent balanced chromosomal translocations involving chromosomal segments 11q23 (KMT2A, previously called MLL) or 21q22.1 (RUNX1), and PML-RARA).
- Relationship between SRSF2 gene mutation and cumulative dose, dose intensity, time of exposure and prognostic criteria (disease free survival, overall survival and disease course).
Read the detailed description
Therapy-related myeloid neoplasms (t-MNs) are a group of hematologic diseases that arise after chemotherapy and/or radiation therapy for a previous cancer or rarely autoimmune diseases.
The revised 2016 World Heath Organization (WHO) classification defines t-MN as a subgroup of acute myeloid leukemia (AML) comprising myelodysplastic syndrome (t-MDS), acute myeloid leukemia (t-AML), and myelodysplastic/myeloproliferative neoplasms (t-MDS/MPN) .
Two forms of t-MN have been recognized. Alkylating agent/radiation-related t-MN usually appears 4 to 7 years, which is frequently associated with unbalanced chromosomal abnormalities involving chromosomes 5 and/or 7, as well mutations or loss of TP53 ( tumor protein 53).
In contrast, a combination of different topoisomerase II inhibitor-related t-MNs is associated with a high incidence of recurrent balanced translocations involving chromosomal segments 11q23 (KMT2A), 21q22 (RUNX1), and PML-RARA [1].
T-MNs are characterized by a subset of molecular mutations including SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, STAG2, and TP53.
RNA splicing is a process that produces mature mRNAs by excising introns and splicing exons from pre-messenger RNA. The spliceosome mutations induce an abnormally spliced mRNA species and compromising hematopoiesis.
One of the potential candidate genes involved in the RNA splicing pathway is serine and arginine rich splicing factor 2 (SRSF2). SRSF2, located on chromosome 17q25.1, and plays a role in preventing exon skipping, confirming the accuracy of splicing and regulating alternative pre-mRNA splicing. Many studies have already reported the potential prognostic value of SRSF2 mutations, which have an adverse prognostic impact on survival and disease progression.
Somatic mutations recently identified in patients with de novo AML and MDS, such as those of epigenetic regulators, spliceosome machinery and SETBP1, are rare, with the exception of SRSF2.
TP53 mutations have been associated to the occurrence of cytogenetic abnormalities and poor response to chemotherapy that are typical of t-MN.
On the other hand, several studies have shown that the presence of isochromosome 17q i(17q) abnormality is associated with wild-type TP53 and mutations in SETBP1 and SRSF2.
Also, somatic loss of one copy of the long arm of chromosome 7 del(7q) is associated with unfavorable prognosis and can co-occur with the SRSF2 mutation in patients with MDS and AML.
- Being tested
- PCR and cytogenetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR and cytogeneticsDiagnostic test
detection of SRSF2 gene mutation and cytogenetic studies
| Study group | Role | What they receive |
|---|---|---|
| AML | cases with denovo AML and t-AML Receives: Diagnostic Test: PCR and cytogenetics | |
| MDS | cases with denovo MDS and t-MDS Receives: Diagnostic Test: PCR and cytogenetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRSF2 gene mutation detection in t-MDS/AML.
Detect SRSF2 gene mutation by polymerase chain reaction (PCR) in the two types of t-MDS/AML which recognized in the WHO classification.
Measured: about 2 years
Secondary outcomes (1)
Cytogenetic analysis (FISH) of patient with t-MDS/AML.
Cytogenetic analysis (FISH), e.g. (Loss of chromosome 7 or del(7q), del(5q), lsochromosome 17q, recurrent balanced chromosomal translocations involving chromosomal segments 11q23 (KMT2A, previously called MLL) or 21q22.1 (RUNX1), and PML-RARA) in the two types of t-MDS/AML which recognized in the WHO classification.
.
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start2 Jun 2019
- Primary completion29 Dec 2019
- Study completion29 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Therapy Related Myelodysplastic Syndrome and Therapy Related Acute Myeloid LeukemiaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeinab Albadry Mohammed Zahran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeinab Albadry Mohammed Zahran, Assiut University
- Investigators
- Zeinab Abdel-Aal Jad Elrab, Professor, Study director, Clinical pathology Department, Faculty of Medicine, Assiut UniversitySahar Abdullah El-Gammal, Assistant Professor, Principal investigator, Clinical pathology Department, Faculty of Medicine, Assiut UniversityMadleen Adel Attia, Assistant Professor, Principal investigator, Clinical pathology Department, Faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894852
- Sponsor's protocol ID
- SRSF2 mutation in t-MDS/AML
- Status last verified
- May 2020
- First submitted
- 27 Mar 2019
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fianchi L, Criscuolo M, Fabiani E, Falconi G, Maraglino AME, Voso MT, Pagano L. Therapy-related myeloid neoplasms: clinical perspectives. Onco Targets Ther. 2018 Sep 17;11:5909-5915. doi: 10.2147/OTT.S101333. eCollection 2018.
PubMed 30271175Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.
PubMed 27069254Sella T, Stone RM. The impact of new drugs for breast and ovarian cancer on the occurrence of therapy-related myeloid neoplasms: Understanding the baseline incidence. Gynecol Oncol. 2018 Nov;151(2):187-189. doi: 10.1016/j.ygyno.2018.10.013. No abstract available.
PubMed 30384959Hoskins AA, Moore MJ. The spliceosome: a flexible, reversible macromolecular machine. Trends Biochem Sci. 2012 May;37(5):179-88. doi: 10.1016/j.tibs.2012.02.009. Epub 2012 Apr 3.
PubMed 22480731Boultwood J, Dolatshad H, Varanasi SS, Yip BH, Pellagatti A. The role of splicing factor mutations in the pathogenesis of the myelodysplastic syndromes. Adv Biol Regul. 2014 Jan;54:153-61. doi: 10.1016/j.jbior.2013.09.005. Epub 2013 Sep 15.
PubMed 24080589Maciejewski JP, Padgett RA. Defects in spliceosomal machinery: a new pathway of leukaemogenesis. Br J Haematol. 2012 Jul;158(2):165-173. doi: 10.1111/j.1365-2141.2012.09158.x. Epub 2012 May 18.
PubMed 22594801Armstrong RN, Steeples V, Singh S, Sanchi A, Boultwood J, Pellagatti A. Splicing factor mutations in the myelodysplastic syndromes: target genes and therapeutic approaches. Adv Biol Regul. 2018 Jan;67:13-29. doi: 10.1016/j.jbior.2017.09.008. Epub 2017 Sep 22.
PubMed 28986033Fabiani E, Falconi G, Fianchi L, Criscuolo M, Ottone T, Cicconi L, Hohaus S, Sica S, Postorino M, Neri A, Lionetti M, Leone G, Lo-Coco F, Voso MT. Clonal evolution in therapy-related neoplasms. Oncotarget. 2017 Feb 14;8(7):12031-12040. doi: 10.18632/oncotarget.14509.
PubMed 28076841Visconte V, Tabarroki A, Zhang L, Hasrouni E, Gerace C, Frum R, Ai J, Advani AS, Duong HK, Kalaycio M, Saunthararajah Y, Sekeres MA, His ED, Shetty S, Rogers HJ, Tiu RV. Clinicopathologic and molecular characterization of myeloid neoplasms harboring isochromosome 17(q10). Am J Hematol. 2014 Aug;89(8):862. doi: 10.1002/ajh.23755. Epub 2014 May 16. No abstract available.
PubMed 24796269Meggendorfer M, Bacher U, Alpermann T, Haferlach C, Kern W, Gambacorti-Passerini C, Haferlach T, Schnittger S. SETBP1 mutations occur in 9% of MDS/MPN and in 4% of MPN cases and are strongly associated with atypical CML, monosomy 7, isochromosome i(17)(q10), ASXL1 and CBL mutations. Leukemia. 2013 Sep;27(9):1852-60. doi: 10.1038/leu.2013.133. Epub 2013 Apr 30.
PubMed 23628959Papapetrou EP. Patient-derived induced pluripotent stem cells in cancer research and precision oncology. Nat Med. 2016 Dec 6;22(12):1392-1401. doi: 10.1038/nm.4238.
PubMed 27923030Kanagal-Shamanna R, Bueso-Ramos CE, Barkoh B, Lu G, Wang S, Garcia-Manero G, Vadhan-Raj S, Hoehn D, Medeiros LJ, Yin CC. Myeloid neoplasms with isolated isochromosome 17q represent a clinicopathologic entity associated with myelodysplastic/myeloproliferative features, a high risk of leukemic transformation, and wild-type TP53. Cancer. 2012 Jun 1;118(11):2879-88. doi: 10.1002/cncr.26537. Epub 2011 Oct 28.
PubMed 22038701
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SRSF2 Gene Mutation in Patients With Therapy Related Myelodysplastic Syndromes / Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03894852
- Acronym / sponsor ID
- SRSF2 mutation in t-MDS/AML
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Zeinab Albadry Mohammed ZahranUniversity, hospital or other
- Study start
- 2 Jun 2019 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 29 Mar 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.
- To detect SRSF2 gene mutation by polymerase chain reaction (PCR) in the two types of t-MDS/AML which recognized in the WHO classification.
- Association between SRSF2 gene mutation and the presence of other cytogenetic abnormalities in the two types of t-MDS/AML which recognized in the WHO classification, e.g. (Loss of chromosome 7 or del(7q), del(5q), isochromosome 17q, recurrent balanced chromosomal translocations involving chromosomal segments 11q23 (KMT2A, previously called MLL) or 21q22.1 (RUNX1), and PML-RARA).
- Relationship between SRSF2 gene mutation and cumulative dose, dose intensity, time of exposure and prognostic criteria (disease free survival, overall survival and disease course).
Detailed description
Therapy-related myeloid neoplasms (t-MNs) are a group of hematologic diseases that arise after chemotherapy and/or radiation therapy for a previous cancer or rarely autoimmune diseases.
The revised 2016 World Heath Organization (WHO) classification defines t-MN as a subgroup of acute myeloid leukemia (AML) comprising myelodysplastic syndrome (t-MDS), acute myeloid leukemia (t-AML), and myelodysplastic/myeloproliferative neoplasms (t-MDS/MPN) .
Two forms of t-MN have been recognized. Alkylating agent/radiation-related t-MN usually appears 4 to 7 years, which is frequently associated with unbalanced chromosomal abnormalities involving chromosomes 5 and/or 7, as well mutations or loss of TP53 ( tumor protein 53).
In contrast, a combination of different topoisomerase II inhibitor-related t-MNs is associated with a high incidence of recurrent balanced translocations involving chromosomal segments 11q23 (KMT2A), 21q22 (RUNX1), and PML-RARA [1].
T-MNs are characterized by a subset of molecular mutations including SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, STAG2, and TP53.
RNA splicing is a process that produces mature mRNAs by excising introns and splicing exons from pre-messenger RNA. The spliceosome mutations induce an abnormally spliced mRNA species and compromising hematopoiesis.
One of the potential candidate genes involved in the RNA splicing pathway is serine and arginine rich splicing factor 2 (SRSF2). SRSF2, located on chromosome 17q25.1, and plays a role in preventing exon skipping, confirming the accuracy of splicing and regulating alternative pre-mRNA splicing. Many studies have already reported the potential prognostic value of SRSF2 mutations, which have an adverse prognostic impact on survival and disease progression.
Somatic mutations recently identified in patients with de novo AML and MDS, such as those of epigenetic regulators, spliceosome machinery and SETBP1, are rare, with the exception of SRSF2.
TP53 mutations have been associated to the occurrence of cytogenetic abnormalities and poor response to chemotherapy that are typical of t-MN.
On the other hand, several studies have shown that the presence of isochromosome 17q i(17q) abnormality is associated with wild-type TP53 and mutations in SETBP1 and SRSF2.
Also, somatic loss of one copy of the long arm of chromosome 7 del(7q) is associated with unfavorable prognosis and can co-occur with the SRSF2 mutation in patients with MDS and AML.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AML | – | Diagnostic Test: PCR and cytogeneticscases with denovo AML and t-AML |
| MDS | – | Diagnostic Test: PCR and cytogeneticscases with denovo MDS and t-MDS |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cases diagnosed therapy related MDS/AML admitted to department of Clinical Pathology, in the south Egypt cancer institute and Assiut University Hospital.
Key inclusion criteria (3 listed)
- Patients with myelodysplastic syndromes (MDS), who fulfill the WHO criteria.
- Patients with acute myeloid leukemia (AML), who fulfill the WHO criteria.
- Patients must start therapy (cytotoxic agents and/or ionizing radiotherapy) before beginning of the study, with a documented history of a benign or malignant condition for which they had received therapy prior to the diagnosis of MDS or AML.
Key exclusion criteria (1 listed)
- Patients not fulfill the WHO criteria for diagnosis of MDS and AML.
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 |
|---|---|---|
| PCR and cytogeneticsdetection of SRSF2 gene mutation and cytogenetic studies | Diagnostic test | AML, MDS |
Primary outcome
SRSF2 gene mutation detection in t-MDS/AML.
Time frame: about 2 years
Detect SRSF2 gene mutation by polymerase chain reaction (PCR) in the two types of t-MDS/AML which recognized in the WHO classification.
1 secondary outcome
Cytogenetic analysis (FISH) of patient with t-MDS/AML.
Time frame: about 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 30271175Fianchi L, Criscuolo M, Fabiani E, Falconi G, Maraglino AME, Voso MT, Pagano L. Therapy-related myeloid neoplasms: clinical perspectives. Onco Targets Ther. 2018 Sep 17;11:5909-5915. doi: 10.2147/OTT.S101333. eCollection 2018.
- Background: PubMed 27069254Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.
- Background: PubMed 30384959Sella T, Stone RM. The impact of new drugs for breast and ovarian cancer on the occurrence of therapy-related myeloid neoplasms: Understanding the baseline incidence. Gynecol Oncol. 2018 Nov;151(2):187-189. doi: 10.1016/j.ygyno.2018.10.013. No abstract available.
- Background: PubMed 22480731Hoskins AA, Moore MJ. The spliceosome: a flexible, reversible macromolecular machine. Trends Biochem Sci. 2012 May;37(5):179-88. doi: 10.1016/j.tibs.2012.02.009. Epub 2012 Apr 3.
- Background: PubMed 24080589Boultwood J, Dolatshad H, Varanasi SS, Yip BH, Pellagatti A. The role of splicing factor mutations in the pathogenesis of the myelodysplastic syndromes. Adv Biol Regul. 2014 Jan;54:153-61. doi: 10.1016/j.jbior.2013.09.005. Epub 2013 Sep 15.
- Background: PubMed 22594801Maciejewski JP, Padgett RA. Defects in spliceosomal machinery: a new pathway of leukaemogenesis. Br J Haematol. 2012 Jul;158(2):165-173. doi: 10.1111/j.1365-2141.2012.09158.x. Epub 2012 May 18.
- Background: PubMed 28986033Armstrong RN, Steeples V, Singh S, Sanchi A, Boultwood J, Pellagatti A. Splicing factor mutations in the myelodysplastic syndromes: target genes and therapeutic approaches. Adv Biol Regul. 2018 Jan;67:13-29. doi: 10.1016/j.jbior.2017.09.008. Epub 2017 Sep 22.
- Background: PubMed 28076841Fabiani E, Falconi G, Fianchi L, Criscuolo M, Ottone T, Cicconi L, Hohaus S, Sica S, Postorino M, Neri A, Lionetti M, Leone G, Lo-Coco F, Voso MT. Clonal evolution in therapy-related neoplasms. Oncotarget. 2017 Feb 14;8(7):12031-12040. doi: 10.18632/oncotarget.14509.
- Background: PubMed 24796269Visconte V, Tabarroki A, Zhang L, Hasrouni E, Gerace C, Frum R, Ai J, Advani AS, Duong HK, Kalaycio M, Saunthararajah Y, Sekeres MA, His ED, Shetty S, Rogers HJ, Tiu RV. Clinicopathologic and molecular characterization of myeloid neoplasms harboring isochromosome 17(q10). Am J Hematol. 2014 Aug;89(8):862. doi: 10.1002/ajh.23755. Epub 2014 May 16. No abstract available.
- Background: PubMed 23628959Meggendorfer M, Bacher U, Alpermann T, Haferlach C, Kern W, Gambacorti-Passerini C, Haferlach T, Schnittger S. SETBP1 mutations occur in 9% of MDS/MPN and in 4% of MPN cases and are strongly associated with atypical CML, monosomy 7, isochromosome i(17)(q10), ASXL1 and CBL mutations. Leukemia. 2013 Sep;27(9):1852-60. doi: 10.1038/leu.2013.133. Epub 2013 Apr 30.
- Background: PubMed 27923030Papapetrou EP. Patient-derived induced pluripotent stem cells in cancer research and precision oncology. Nat Med. 2016 Dec 6;22(12):1392-1401. doi: 10.1038/nm.4238.
- Background: PubMed 22038701Kanagal-Shamanna R, Bueso-Ramos CE, Barkoh B, Lu G, Wang S, Garcia-Manero G, Vadhan-Raj S, Hoehn D, Medeiros LJ, Yin CC. Myeloid neoplasms with isolated isochromosome 17q represent a clinicopathologic entity associated with myelodysplastic/myeloproliferative features, a high risk of leukemic transformation, and wild-type TP53. Cancer. 2012 Jun 1;118(11):2879-88. doi: 10.1002/cncr.26537. Epub 2011 Oct 28.
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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.
Zeinab Abdel-Aal Jad Elrab, Professor study director
Clinical pathology Department, Faculty of Medicine, Assiut University
Sahar Abdullah El-Gammal, Assistant Professor principal investigator
Clinical pathology Department, Faculty of Medicine, Assiut University
Madleen Adel Attia, Assistant Professor principal investigator
Clinical pathology Department, Faculty of Medicine, Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapy Related Myelodysplastic Syndrome and Therapy Related Acute Myeloid Leukemia, run by Zeinab Albadry Mohammed Zahran at 2 sites in Egypt.
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 3 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: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SRSF2 gene mutation detection in t-MDS/AML. (time frame: about 2 years). 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 NCT03894852, which also lists 12 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 19 May 2020.