Diffuse Large B-cell Lymphoma and Aggressive B-cell LymphomasNCT07804173
Tumour Immune and Ki-67 Scoring Methods as Prognostic Biomarkers in Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas
An observational study of Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas, run by Sohag University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Blocks obtained from patients diagnosed as Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag university
Sohag, 82511
Aliaa Ahmed, 01062157907, aliaa.bek0@gmail.com
About this study
Official title: 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).
Read more
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
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with DLBCL/aggressive B-cell lymphomas with assessed by CD3 and Ki67 proliferation index immunohistochemical staining
Measured: One or two days after staining sections with the markers]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell Lymphoma and Aggressive B-cell LymphomasStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Bakr Ahmed, Sohag University
- Investigators
- Aliaa Bakr Ahmed, MD, Principal investigator, Faculty of medicine, Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804173
- Sponsor's protocol ID
- Soh-Med-26-8--11PD
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07804173
- Acronym / sponsor ID
- Soh-Med-26-8--11PD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Blocks obtained from patients diagnosed as Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas
Key inclusion criteria (6 listed)
- • 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.
Key exclusion criteria (6 listed)
- • Inadequate tissue, exhausted block or severe fixation/processing artifact preventing reliable IHC interpretation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients with DLBCL/aggressive B-cell lymphomas with assessed by CD3 and Ki67 proliferation index immunohistochemical staining
Time frame: One or two days after staining sections with the markers]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aliaa Bakr Ahmed, MD principal investigator
Faculty of medicine, Sohag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-cell Lymphoma and Aggressive B-cell Lymphomas, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliaa Bakr Ahmed, MD (01062157907, aliaa.bakr@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with DLBCL/aggressive B-cell lymphomas with assessed by CD3 and Ki67 proliferation index immunohistochemical staining (time frame: One or two days after staining sections with the markers]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.