此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年9月3日 更新者:Aliaa Bakr Ahmed、Sohag University

Tumour Immune "Hotness" and Ki-67 Scoring Methods as Prognostic Biomarkers in Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas: An Immunohistochemical Study

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

研究概览

研究类型

观察性的

注册 (估计的)

70

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Blocks obtained from patients diagnosed as Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas

描述

Inclusion Criteria:

  • • Patients diagnosed with Diffuse Large B Cell Lymphoma, not otherwise specified (DLBCL, NOS) and other aggressive large B-cell lymphomas, according to current WHO/ICC diagnostic principles.

    • Histopathological diagnosis obtained by excisional biopsy, core biopsy or adequate tissue biopsy.
    • Availability of FFPE tissue blocks with sufficient viable tumor for immunohistochemical (IHC) staining.
    • Diagnostic tissue obtained before the initiation of definitive systemic therapy.
    • Available minimum clinical data: age, sex, date of diagnosis, treatment status, and follow-up/survival status.
    • For survival analysis: cases with documented follow-up date or date of death/progression.

Exclusion Criteria:

  • • Inadequate tissue, exhausted block or severe fixation/processing artifact preventing reliable IHC interpretation.

    • Extensive necrosis, crush artifact or decalcification artifact in the only available diagnostic tissue.
    • Relapse biopsy after chemotherapy without available pretreatment diagnostic tissue.
    • Primary Hodgkin lymphoma, indolent B-cell lymphoma without transformation, T-cell lymphoma or metastatic non-lymphoid malignancy.
    • Cases lacking essential clinical outcome data for prognostic analysis (except for descriptive staining analysis).
    • HIV-associated, post-transplant or primary CNS DLBCL may be excluded or analyzed separately due to distinct biology.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Number of Patients with DLBCL/aggressive B-cell lymphomas with assessed by CD3 and Ki67 proliferation index immunohistochemical staining
大体时间:One or two days after staining sections with the markers]
One or two days after staining sections with the markers]

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Aliaa Bakr Ahmed, MD、Faculty of medicine, Sohag university

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年8月31日

首先提交符合 QC 标准的

2026年9月3日

首次发布 (实际的)

2026年9月4日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅