Relationship Between Serum β2-Microglobulin and Infiltration of CD8+ in the Tumor Tissue of Hodgkin's Lymphoma Patients

NCT06564259 | Completed DMC

• 1 other identifier: 1839
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

In newly diagnosed Hodgkin lymphoma patients, pre-treatment Beta-2 Microglobulin (B2M) levels will be measured. A thorough baseline assessment will be performed using CT imaging, and tumor tissue samples will be collected for Immunohistochemical (IHC) analysis to quantify CD8+ cell infiltration. Patients will be closely monitored throughout their treatment, with a follow-up CT scan at the end of therapy to evaluate therapeutic response. This study aims to investigate the correlation between pre-treatment B2M levels and CD8+ immune cell infiltration in tumor tissues, assessing their potential as predictive markers for chemotherapy response.

Conditions

Hodgkin Lymphoma

Keywords

serum Beta-2 Microglobulin, CD8+ cells, Hodgkin lymphoma, Predictive value, Chemotherapy.

Outcome Measures

Primary Outcomes (1)

• Therapeutic response

  Achieving complete remission after chemotherapy

  2-4 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included a cohort of 144 patients newly diagnosed with Hodgkin lymphoma. Patients were between the ages of 14 and 71 years, with an almost balanced representation of both genders. All participants had a confirmed Hodgkin lymphoma diagnosis based on histopathological examination. The study population reflected a diverse range of disease stages and subtypes, providing a comprehensive understanding of the relationship between pre-treatment Beta-2 Microglobulin (B2M) levels, CD8+ cell infiltration, and chemotherapy response in this patient population.

You may qualify if:

• Newly diagnosed patients with Hodgkin lymphoma
• No prior history of malignancy
• Absence of primary or secondary immunodeficiencies

You may not qualify if:

• Patients who have previously undergone treatment
• Patients with acute or chronic infections
• Patients with renal disorders
• Individuals with autoimmune diseases
• HIV-positive patients

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University

Latakia, Syria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor lymph nodes embedded in paraffin

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Firas Hussien, Prof.

  Tishreen University

  STUDY CHAIR

• Maram Bilal, Prof.

  Tishreen University

  STUDY DIRECTOR

• Hasan Khalil, Ms

  Tishreen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 21, 2024
• Study Start: January 4, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SY (1)