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

SARS-CoV-2 Infection Clinical Trial

Official title:

Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors and Discovery of Potential Drug Targets

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05683353
• Other study ID #: PekingUFH_
• Status: Active, not recruiting
• Start date: December 14, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

To establish a retrospective and prospective cohort of patients with hematologic tumors infected with SARS-CoV-2 and people without underlying diseases infected with SARS-CoV-2. Firstly, peripheral blood samples will be collected at infection time points and after SARS-CoV-2 nucleic acid testing turns negative. Subsequently, the transcriptome sequencing and immunological experiments will be performed to analyze the differentially expressed genes, immune function of cells, etc.

Comparative analysis:

1. To compare the immune function of patients with hematologic tumors and those without underlying diseases after infection with SARS-CoV-2.

2. The transcriptomic and proteomic changes of patients with hematologic tumors are compared with those without underlying diseases after infection with SARS-CoV-2.

3. From the perspective of complex (human protein interaction subnetwork), the dynamic change process of SARS-CoV-2-targeted human protein complex (periodic complex) was deeply explored, in order to further analyze its potential dynamic infection mechanism and provide new clues for the discovery of drug targets.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Severe diseases associated with other systems

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Hematologic Malignancy
• Hematologic Neoplasms
• Infections
• Neoplasms
• SARS-CoV-2 Infection

Intervention

Other:
• None intervention
None intervention.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Erratum In: Cell. 2022 Mar 31;185(7):1259. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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