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出境医 / 临床实验 / Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL

Study Description
Brief Summary:
ETP-ALL is a recently recognized high-risk subgroup and the optimal therapeutic approaches are poorly characterized. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial is aimed to evaluate the safety and effect of a novel oral histone deacetylase inhibitor chidamide for adult ETP-ALL/LBL in CHINA.

Condition or disease Intervention/treatment Phase
Leukemia, Acute Leukemia, T Cell Leukemia, Lymphoblastic Drug: Chidamide Drug: Dexamethasone Drug: vincristine Drug: Cyclophosphamide Drug: Idarubicin Drug: Pegaspargase Drug: Adriamycin Drug: Methotrexate Drug: 6-Mercaptopurine Drug: Etoposide Drug: Cytarabine Procedure: Bone marrow aspiration Procedure: Intrathecal injection Radiation: Radiation therapy Genetic: NGS Procedure: allogeneic hematopoietic stem cell transplantation Diagnostic Test: Flow-MRD Diagnostic Test: FISH Diagnostic Test: Flow immunophenotyping Diagnostic Test: Karyotyping Phase 2 Phase 3

Detailed Description:

Early T-cell precursor (ETP) lymphoblastic leukemia (ETP-ALL) is a neoplasm composed of cells committed to the T-cell lineage but with an unique immunophenotype indicating only limited early T differentiation. In the highly orchestrated development of T cell fate specification under physiological condition, the most immature early thymic progenitors (ETPs) retain multilineage potentials. ETP-ALL blasts have a characteristic immunophenotype, with reduced/absent expression of T-lymphoid markers CD1a, CD5, CD8; and positivity for at least one HSC and/or myeloid antigen CD34, CD117, HLA-DR, CD13, CD33, CD11b, CD65. Recent study shed light on the genetic landscape of adult ETP-ALL, which revealed that more than 40% adult ETP-ALL harbored histone modification mutations. Chidamide is a novel oral HDACi with promising activity in non-Hodgkin lymphoma (NHL). Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial is aimed to evaluate the safety and effect of a novel oral histone deacetylase inhibitor chidamide for adult ETP-ALL/LBL. HDACi chidamide at a dose of 10mg/day will be added to ETP-ALL group from induction therapy to consolidation therapy (total courses of chidamide treatment: 5 courses for allo-HSCT after Consolidation Module-3; 12 courses for patients non-allo-HSCT after Consolidation Module 1-9). Primary study endpoint of PDT-ETP-ALL is event-free survival of ETP-ALL group and secondary study endpoints are complete remission and MRD after induction, adverse event and overall survival of ETP-ALL group.

Pretreatment: Dexamethasone, -3 to 0d;

Induction:VCR: 1, 8, 15, 22; IDA: 1, 8; CTX: 1g/m2, 1, 8; PEG-asp: 2000-2500IU/m2, 1, 15; Dex: 1-24, chidamide: 10mg/d, po, qd.

MRD: d14, 24, 45, and pre-allo-HSCT.

VLCAM (MRD1/d14>1%): CTX, d25; AraC 2g/m2, q12h, d25, 26; 6-MP: 25-31, PEG-asp: 26; chidamide: 10mg/d, po, qd.

Consolidation Module:

CM-1: AraC 3g/m2, q12h, 1-2, Dex: 10mg/m2, 1-2, PEG-asp: 2, 6-MP: 1-7. IT: d1, chidamide: 10mg/d, po, qd.

CM-2: MTX 5g/m2, 1, Dex: 10mg/m2, 1-2, PEG-asp: 2; 6-MP: 1-7; IT: d1; chidamide: 10mg/d, po, qd.

CM-3: CTX 0.5g/m2, 1-3, PEG-asp: 2, Doxorubicin: 40mg/m2, 4, 6-MP: 1-7, IT: d1;chidamide: 10mg/d, po, qd.

Allo-HSCT: after CM-3 when donors available. Non-HSCT: finish CM 4-9 and POMP maintenance.

CM 4-6: repeat CM 1-3. Re-Induction: after CM-6. CM 7-9: repeat CM1-3.

Maintenance: CPOMP-chidamide 10mg/d, po, qd; Pred for 12 months; VCR for 12 months; MTX for 24 months; 6-MP for 24 months.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma
Actual Study Start Date : February 14, 2016
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : August 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: ETP-ALL
Chidamide at a dose of 10mg/day will be added to PDT-ETP-ALL protocol. The intervention of PDT-ETP-ALL consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, Karyotyping ，FISH, NGS, Flow-MRD, PET-CT scan), induction regimen (chidamide, dexamethasone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide, adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen (chidamide, prednisone, vincristine, methotrexate, 6-mercaptopurine), intrathecal injection chemotherapy, radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.
 Drug: Chidamide
Chidamide will be administrated at a dose of 10mg/day in PDT-ETP-ALL protocol.
Other Name: HDACi chidamide

Drug: Dexamethasone
Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ETP-ALL protocol.
Other Name: DXM

Drug: vincristine
Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
Other Name: VCR

Drug: Cyclophosphamide
CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
Other Name: CTX

Drug: Idarubicin
IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.
Other Name: IDA

Drug: Pegaspargase
PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.
Other Name: PEG-ASP

Drug: Adriamycin
Adriamycin will be added to Consolidation-Module of PDT-ETP-ALL protocol.
Other Name: ADR

Drug: Methotrexate
Methotrexate will be added to consolidation module of PDT-ETP-ALL protocol.
Other Name: MTX

Drug: 6-Mercaptopurine
Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
Other Name: 6-MP

Drug: Etoposide
VP-16 will be added to Consolidation-Module of PDT-ETP-ALL protocol.
Other Name: VP-16

Drug: Cytarabine
AraC will be added to Consolidation-Module of PDT-ETP-ALL protocol.
Other Name: AraC

Procedure: Bone marrow aspiration
Bone marrow aspiration and additional tests will be performed in all module of PDT-ETP-ALL protocol.
Other Name: BM test

Procedure: Intrathecal injection
Intrathecal injection chemotherapy will be performed in PDT-ETP-ALL protocol.
Other Name: IT

Radiation: Radiation therapy
Radiation therapy will be performed for mediastinum and/or central nervous system leukemia in PDT-ETP-ALL protocol.
Other Name: RT

Genetic: NGS
Next-Generation-Sequencing (NGS) will be performed in PDT-ETP-ALL protocol.

Procedure: allogeneic hematopoietic stem cell transplantation
Allo-HSCT will be performed for patients with available donor in PDT-ETP-ALL protocol.
Other Name: allo-HSCT

Diagnostic Test: Flow-MRD
Flow-MRD will be added to PDT-ETP-ALL for bone marrow and cerebrospinal fluid samples.

Diagnostic Test: FISH
FISH will be performed in PDT-ETP-ALL for bone marrow samples.

Diagnostic Test: Flow immunophenotyping
Flow immunophenotyping will be performed in PDT-ETP-ALL protocol.

Diagnostic Test: Karyotyping
Karyotyping will be performed in PDT-ETP-ALL protocol.
Outcome Measures
Primary Outcome Measures :
  1. Event free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Minimum residual disease after induction [ Time Frame: 3 months ]
  2. CR after Induction Therapy [ Time Frame: 3 years ]
  3. Death in induction [ Time Frame: 3 month ]
  4. Adverse events [ Time Frame: 3 years ]
  5. Relapse [ Time Frame: 3 years ]
  6. Relapse free survival [ Time Frame: 3 years ]
  7. Overall survival [ Time Frame: 3 years ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   14 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 14-55 years old;
  • ETP-ALL newly diagnosed;
  • signed written informed consent

Exclusion Criteria:

  • Pregnant women;
  • History of pancreatitis;
  • History of diabetes;
  • History of active peptic ulcer disease in the past 6 months;
  • History of arteriovenous thrombosis in the past 6 months;
  • Severe active infection;
  • Allergic to any drugs in PDT-ETP-ALL.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Hongsheng Zhou, MD, Ph.D +862062787349 zhs1@i.smu.edu.cn

Locations
Layout table for location information
China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Hongsheng Zhou, MD, PhD    +862062787349    zhs1@i.smu.edu.cn   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Layout table for investigator information
Study Director: Hongsheng Zhou, MD, PhD Nanfang Hospital, Southern Medical University, CHINA
Tracking Information
First Submitted Date  ICMJE April 21, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE February 14, 2016
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2018) 		Event free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
  • Minimum residual disease after induction [ Time Frame: 3 months ]
  • CR after Induction Therapy [ Time Frame: 3 years ]
  • Death in induction [ Time Frame: 3 month ]
  • Adverse events [ Time Frame: 3 years ]
  • Relapse [ Time Frame: 3 years ]
  • Relapse free survival [ Time Frame: 3 years ]
  • Overall survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL
Official Title  ICMJE An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma
Brief Summary ETP-ALL is a recently recognized high-risk subgroup and the optimal therapeutic approaches are poorly characterized. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial is aimed to evaluate the safety and effect of a novel oral histone deacetylase inhibitor chidamide for adult ETP-ALL/LBL in CHINA.
Detailed Description

Early T-cell precursor (ETP) lymphoblastic leukemia (ETP-ALL) is a neoplasm composed of cells committed to the T-cell lineage but with an unique immunophenotype indicating only limited early T differentiation. In the highly orchestrated development of T cell fate specification under physiological condition, the most immature early thymic progenitors (ETPs) retain multilineage potentials. ETP-ALL blasts have a characteristic immunophenotype, with reduced/absent expression of T-lymphoid markers CD1a, CD5, CD8; and positivity for at least one HSC and/or myeloid antigen CD34, CD117, HLA-DR, CD13, CD33, CD11b, CD65. Recent study shed light on the genetic landscape of adult ETP-ALL, which revealed that more than 40% adult ETP-ALL harbored histone modification mutations. Chidamide is a novel oral HDACi with promising activity in non-Hodgkin lymphoma (NHL). Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial is aimed to evaluate the safety and effect of a novel oral histone deacetylase inhibitor chidamide for adult ETP-ALL/LBL. HDACi chidamide at a dose of 10mg/day will be added to ETP-ALL group from induction therapy to consolidation therapy (total courses of chidamide treatment: 5 courses for allo-HSCT after Consolidation Module-3; 12 courses for patients non-allo-HSCT after Consolidation Module 1-9). Primary study endpoint of PDT-ETP-ALL is event-free survival of ETP-ALL group and secondary study endpoints are complete remission and MRD after induction, adverse event and overall survival of ETP-ALL group.

Pretreatment: Dexamethasone, -3 to 0d;

Induction:VCR: 1, 8, 15, 22; IDA: 1, 8; CTX: 1g/m2, 1, 8; PEG-asp: 2000-2500IU/m2, 1, 15; Dex: 1-24, chidamide: 10mg/d, po, qd.

MRD: d14, 24, 45, and pre-allo-HSCT.

VLCAM (MRD1/d14>1%): CTX, d25; AraC 2g/m2, q12h, d25, 26; 6-MP: 25-31, PEG-asp: 26; chidamide: 10mg/d, po, qd.

Consolidation Module:

CM-1: AraC 3g/m2, q12h, 1-2, Dex: 10mg/m2, 1-2, PEG-asp: 2, 6-MP: 1-7. IT: d1, chidamide: 10mg/d, po, qd.

CM-2: MTX 5g/m2, 1, Dex: 10mg/m2, 1-2, PEG-asp: 2; 6-MP: 1-7; IT: d1; chidamide: 10mg/d, po, qd.

CM-3: CTX 0.5g/m2, 1-3, PEG-asp: 2, Doxorubicin: 40mg/m2, 4, 6-MP: 1-7, IT: d1;chidamide: 10mg/d, po, qd.

Allo-HSCT: after CM-3 when donors available. Non-HSCT: finish CM 4-9 and POMP maintenance.

CM 4-6: repeat CM 1-3. Re-Induction: after CM-6. CM 7-9: repeat CM1-3.

Maintenance: CPOMP-chidamide 10mg/d, po, qd; Pred for 12 months; VCR for 12 months; MTX for 24 months; 6-MP for 24 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia, Acute
  • Leukemia, T Cell
  • Leukemia, Lymphoblastic
Intervention  ICMJE
  • Drug: Chidamide
    Chidamide will be administrated at a dose of 10mg/day in PDT-ETP-ALL protocol.
    Other Name: HDACi chidamide
  • Drug: Dexamethasone
    Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ETP-ALL protocol.
    Other Name: DXM
  • Drug: vincristine
    Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
    Other Name: VCR
  • Drug: Cyclophosphamide
    CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
    Other Name: CTX
  • Drug: Idarubicin
    IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.
    Other Name: IDA
  • Drug: Pegaspargase
    PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.
    Other Name: PEG-ASP
  • Drug: Adriamycin
    Adriamycin will be added to Consolidation-Module of PDT-ETP-ALL protocol.
    Other Name: ADR
  • Drug: Methotrexate
    Methotrexate will be added to consolidation module of PDT-ETP-ALL protocol.
    Other Name: MTX
  • Drug: 6-Mercaptopurine
    Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
    Other Name: 6-MP
  • Drug: Etoposide
    VP-16 will be added to Consolidation-Module of PDT-ETP-ALL protocol.
    Other Name: VP-16
  • Drug: Cytarabine
    AraC will be added to Consolidation-Module of PDT-ETP-ALL protocol.
    Other Name: AraC
  • Procedure: Bone marrow aspiration
    Bone marrow aspiration and additional tests will be performed in all module of PDT-ETP-ALL protocol.
    Other Name: BM test
  • Procedure: Intrathecal injection
    Intrathecal injection chemotherapy will be performed in PDT-ETP-ALL protocol.
    Other Name: IT
  • Radiation: Radiation therapy
    Radiation therapy will be performed for mediastinum and/or central nervous system leukemia in PDT-ETP-ALL protocol.
    Other Name: RT
  • Genetic: NGS
    Next-Generation-Sequencing (NGS) will be performed in PDT-ETP-ALL protocol.
  • Procedure: allogeneic hematopoietic stem cell transplantation
    Allo-HSCT will be performed for patients with available donor in PDT-ETP-ALL protocol.
    Other Name: allo-HSCT
  • Diagnostic Test: Flow-MRD
    Flow-MRD will be added to PDT-ETP-ALL for bone marrow and cerebrospinal fluid samples.
  • Diagnostic Test: FISH
    FISH will be performed in PDT-ETP-ALL for bone marrow samples.
  • Diagnostic Test: Flow immunophenotyping
    Flow immunophenotyping will be performed in PDT-ETP-ALL protocol.
  • Diagnostic Test: Karyotyping
    Karyotyping will be performed in PDT-ETP-ALL protocol.
Study Arms  ICMJE Experimental: ETP-ALL
Chidamide at a dose of 10mg/day will be added to PDT-ETP-ALL protocol. The intervention of PDT-ETP-ALL consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, Karyotyping ，FISH, NGS, Flow-MRD, PET-CT scan), induction regimen (chidamide, dexamethasone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide, adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen (chidamide, prednisone, vincristine, methotrexate, 6-mercaptopurine), intrathecal injection chemotherapy, radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.
Interventions:
  • Drug: Chidamide
  • Drug: Dexamethasone
  • Drug: vincristine
  • Drug: Cyclophosphamide
  • Drug: Idarubicin
  • Drug: Pegaspargase
  • Drug: Adriamycin
  • Drug: Methotrexate
  • Drug: 6-Mercaptopurine
  • Drug: Etoposide
  • Drug: Cytarabine
  • Procedure: Bone marrow aspiration
  • Procedure: Intrathecal injection
  • Radiation: Radiation therapy
  • Genetic: NGS
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Diagnostic Test: Flow-MRD
  • Diagnostic Test: FISH
  • Diagnostic Test: Flow immunophenotyping
  • Diagnostic Test: Karyotyping
Publications *
  • Koch U, Radtke F. Mechanisms of T cell development and transformation. Annu Rev Cell Dev Biol. 2011;27:539-62. doi: 10.1146/annurev-cellbio-092910-154008. Epub 2011 Jul 5. Review.
  • Arber 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. Review.
  • Bond J, Graux C, Lhermitte L, Lara D, Cluzeau T, Leguay T, Cieslak A, Trinquand A, Pastoret C, Belhocine M, Spicuglia S, Lheritier V, Leprêtre S, Thomas X, Huguet F, Ifrah N, Dombret H, Macintyre E, Boissel N, Asnafi V. Early Response-Based Therapy Stratification Improves Survival in Adult Early Thymic Precursor Acute Lymphoblastic Leukemia: A Group for Research on Adult Acute Lymphoblastic Leukemia Study. J Clin Oncol. 2017 Aug 10;35(23):2683-2691. doi: 10.1200/JCO.2016.71.8585. Epub 2017 Jun 12.
  • Yu S, Zhou X, Steinke FC, Liu C, Chen SC, Zagorodna O, Jing X, Yokota Y, Meyerholz DK, Mullighan CG, Knudson CM, Zhao DM, Xue HH. The TCF-1 and LEF-1 transcription factors have cooperative and opposing roles in T cell development and malignancy. Immunity. 2012 Nov 16;37(5):813-26. doi: 10.1016/j.immuni.2012.08.009. Epub 2012 Oct 25. Erratum in: Immunity. 2014 Jan 16;40(1):166.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2018) 		70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 14-55 years old;
  • ETP-ALL newly diagnosed;
  • signed written informed consent

Exclusion Criteria:

  • Pregnant women;
  • History of pancreatitis;
  • History of diabetes;
  • History of active peptic ulcer disease in the past 6 months;
  • History of arteriovenous thrombosis in the past 6 months;
  • Severe active infection;
  • Allergic to any drugs in PDT-ETP-ALL.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553238
Other Study ID Numbers  ICMJE PDT-ETP-ALL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qifa Liu, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hongsheng Zhou, MD, PhD Nanfang Hospital, Southern Medical University, CHINA
PRS Account Nanfang Hospital of Southern Medical University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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