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Tumour Immune and Ki-67 Scoring Methods as Prognostic Biomarkers in Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas

NCT07804173 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-09-04

No results posted yet for this study

Summary

Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive non-Hodgkin lymphoma with heterogeneity in its clinical presentations, biological behaviour and response to therapy (1-4). Nevertheless, despite R-CHOP chemotherapy being successful, a high percentage of patients relapsed early or were primary refractory, highlighting the urgent need for more accurate prognostic biomarkers (2,5).

With the emergence of new discoveries in cancer immunology, the focus has shifted to the tumour microenvironment (TME). The density and presence of tumour-infiltrating lymphocytes (TILs), especially CD3+ T cells and CD8+ cytotoxic T lymphocytes, are key determinants of the anti-tumour immune response (6-8). Now tumours are classified by their immune 'hotness'. 'Hot' tumours, with high T-cell infiltration, are associated with a better prognosis, whereas 'cold' tumours, with immune exclusion or desertion, are associated with a poorer prognosis (9-10).

On the other hand, the Ki-67 proliferation index is still the gold standard marker to measure the growth fraction of neoplastic cells (11). However, the optimal scoring method is yet to be established (12-13). Prognostic information may be obtained by global scoring (i.e. the proliferation index averaged over the whole tumour) and hotspot scoring (i.e. the area of maximum proliferation) (14-15).

In aggressive lymphomas the hotspot index could be a better representation of the highly proliferative clones that drive clinical progression (16-17). The present study was done to assess the combined effect of immune infiltration (CD3/CD8) and proliferation (Ki-67) to build a more accurate prognostic model for patients with DLBCL and other aggressive B-cell lymphomas treated

Conditions

  • Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Aliaa Bakr Ahmed, MD · Faculty of medicine, Sohag university

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-01-01
Completion
2027-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804173 on ClinicalTrials.gov