NCT05683353

Brief Summary

The goal of this observational study is to compare the immune function and infection mechanism of patients with hematologic tumors and those people without underlying diseases after infection with SARS-CoV-2. Clinical characteristics, treatment options and responses will be collected. Peripheral blood will be collected from patients with hematologic tumors infected with SARS-CoV-2 and those people without underlying diseases infected with SARS-CoV-2.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Dec 2022Dec 2027

Study Start

First participant enrolled

December 14, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

5 years

First QC Date

January 4, 2023

Last Update Submit

September 14, 2026

Conditions

SARS-CoV-2 InfectionHematologic Malignancy

Keywords

SARS-CoV-2 infectionhematologic malignancyleukemiainteractionimmune functionnetwork analysis

Outcome Measures

Primary Outcomes (1)

  • Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors

    To compare the infection mechanism and immune function of patients with hematologic tumors infected with SARS-CoV-2 and people infected with SARS-CoV-2 without underlying diseases.

    1 year

Study Arms (2)

Patients with SARS-CoV-2 positive hematologic tumors

Patients with SARS-CoV-2 positive hematologic tumors over 18 years old excluding patients with severe diseases associated with other systems.

Other: None intervention

People with SARS-CoV-2 positive without underlying diseases

People with SARS-CoV-2 positive without underlying diseases over 18 years old excluding people with severe diseases associated with other systems.

Other: None intervention

Interventions

None interventionOTHER

None intervention.

Patients with SARS-CoV-2 positive hematologic tumorsPeople with SARS-CoV-2 positive without underlying diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients with SARS-CoV-2 positive hematologic tumors over 18 years old. People with SARS-CoV-2 positive without underlying diseases over 18 years old.

You may qualify if:

  • \- Clinical diagnosis of hematologic tumors Clinical diagnosis of SARS-CoV-2 infection

You may not qualify if:

  • \- Severe diseases associated with other systems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (7)

  • Naranbhai V, Nathan A, Kaseke C, Berrios C, Khatri A, Choi S, Getz MA, Tano-Menka R, Ofoman O, Gayton A, Senjobe F, Zhao Z, St Denis KJ, Lam EC, Carrington M, Garcia-Beltran WF, Balazs AB, Walker BD, Iafrate AJ, Gaiha GD. T cell reactivity to the SARS-CoV-2 Omicron variant is preserved in most but not all individuals. Cell. 2022 Mar 17;185(6):1041-1051.e6. doi: 10.1016/j.cell.2022.01.029. Epub 2022 Feb 3.

    PMID: 35202566BACKGROUND

  • Bange EM, Han NA, Wileyto P, Kim JY, Gouma S, Robinson J, Greenplate AR, Hwee MA, Porterfield F, Owoyemi O, Naik K, Zheng C, Galantino M, Weisman AR, Ittner CAG, Kugler EM, Baxter AE, Oniyide O, Agyekum RS, Dunn TG, Jones TK, Giannini HM, Weirick ME, McAllister CM, Babady NE, Kumar A, Widman AJ, DeWolf S, Boutemine SR, Roberts C, Budzik KR, Tollett S, Wright C, Perloff T, Sun L, Mathew D, Giles JR, Oldridge DA, Wu JE, Alanio C, Adamski S, Garfall AL, Vella LA, Kerr SJ, Cohen JV, Oyer RA, Massa R, Maillard IP, Maxwell KN, Reilly JP, Maslak PG, Vonderheide RH, Wolchok JD, Hensley SE, Wherry EJ, Meyer NJ, DeMichele AM, Vardhana SA, Mamtani R, Huang AC. CD8+ T cells contribute to survival in patients with COVID-19 and hematologic cancer. Nat Med. 2021 Jul;27(7):1280-1289. doi: 10.1038/s41591-021-01386-7. Epub 2021 May 20.

    PMID: 34017137BACKGROUND

  • Ni L, Ye F, Cheng ML, Feng Y, Deng YQ, Zhao H, Wei P, Ge J, Gou M, Li X, Sun L, Cao T, Wang P, Zhou C, Zhang R, Liang P, Guo H, Wang X, Qin CF, Chen F, Dong C. Detection of SARS-CoV-2-Specific Humoral and Cellular Immunity in COVID-19 Convalescent Individuals. Immunity. 2020 Jun 16;52(6):971-977.e3. doi: 10.1016/j.immuni.2020.04.023. Epub 2020 May 3.

    PMID: 32413330BACKGROUND

  • Auwul MR, Rahman MR, Gov E, Shahjaman M, Moni MA. Bioinformatics and machine learning approach identifies potential drug targets and pathways in COVID-19. Brief Bioinform. 2021 Sep 2;22(5):bbab120. doi: 10.1093/bib/bbab120.

    PMID: 33839760BACKGROUND

  • Yang S, Fu C, Lian X, Dong X, Zhang Z. Understanding Human-Virus Protein-Protein Interactions Using a Human Protein Complex-Based Analysis Framework. mSystems. 2019 Apr 9;4(2):e00303-18. doi: 10.1128/mSystems.00303-18. eCollection 2019 Mar-Apr.

    PMID: 30984872BACKGROUND

  • Tang B, Yang X, Tian W, Zhu J, Liu W, Di M, Liu H, Liang Z, Chen Y, Dong Y. Proteomic analysis identifies pathways related to immune dysregulation in patients with hematologic malignancies after COVID-19 infection. Microbiol Spectr. 2026 Aug 4;14(8):e0399625. doi: 10.1128/spectrum.03996-25. Epub 2026 Jul 15.

    PMID: 42454903DERIVED

  • Yang X, Zhu J, Wang Q, Tang B, Shen Y, Wang B, Ji L, Liu H, Wuchty S, Zhang Z, Dong Y, Liang Z. Comparative analysis of dynamic transcriptomes reveals specific COVID-19 features and pathogenesis of immunocompromised populations. mSystems. 2024 Jun 18;9(6):e0138523. doi: 10.1128/msystems.01385-23. Epub 2024 May 16.

    PMID: 38752789DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells are extracted to perform RNA-sequencing.

MeSH Terms

Conditions

COVID-19Hematologic NeoplasmsLeukemia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic Type

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of department of hematology

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

December 14, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 16, 2026

Record last verified: 2026-09

Locations

CN(1)