Chronic Lymphocytic Leukemia (CLL)- Non-Hodgins's Lymphoma (NHL)NCT07157579
Notch 1 Mutation in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patient
An observational study of Chronic Lymphocytic Leukemia (CLL)- Non-Hodgins's Lymphoma (NHL), run by Sohag University.
Trial summary
Detection of Notch1 mutation in BM or peripheral blood of of patients with NHL Detection of Notch1 mutation in BM or peripheral blood of of patients with chronic lymphocytic leukemia . Comparison between expression of mutation in patient with CLL and NHL. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL)- Non-Hodgins's Lymphoma (NHL)
- What is being tested?
- Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples.
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 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: The studied individuals will be classified into 2 groups: Group (I): represent available number of CLL cases Group (II): represents available number of NHL cases
Who may be able to join
None listed.
Who cannot join
- Refusal to sign an informed written consent, patient on chemotherapy sion Criteria:
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of Notch 1 Mutation in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patient
- Detection of Notch1 mutation in BM or peripheral blood of of patients with NHL
- Detection of Notch1 mutation in BM or peripheral blood of of patients with chronic lymphocytic leukemia .
- Comparison between expression of mutation in patient with CLL and NHL.
Read the detailed description
Chronic Lymphocytic Leukemia (CLL), is the most common leukemia in the western world. with a higher incidence in males (1.7:1),Current treatment strategies vary depending on disease burden, from active monitoring in asymptomatic patients, to targeted therapies in more advanced disease.
CLL is characterized by the clonal expansion of B cells with a characteristic immunophenotype (i.e., smIgweak, CD29+, CD23+, CD20weak) that slowly accumulate in peripheral blood, bone marrow, and lymphoid tissues mainly as a result of defects in the apoptosis machinery such as the overexpression of Bcl2 family anti-apoptotic proteins .
The clinical heterogeneity of CLL does reflect differences in the biology of the disease, particularly the IGHV mutational status and chromosomal alterations (i.e., del13q, del11q, trisomy 12 and del17p). Beside del17p/TP53 mutation which is the strongest CLL biomarker for response to therapy, other mutations (e.g., SF3B1, ATM, NOTCH1, BRIC3) have been reported to correlate with the outcome of the disease, but they are not actionable yet .
Non-Hodgins's lymphoma (NHL), the most common hematological malignancy worldwide, refers to a diverse class of B-cell and T-cell proliferations. NHL is differentiated from Hodgkin's lymphoma by different clinical characteristics and the absence of Reed-Sternberg cells and Cd15 and Cd30 staining on histology .
There are over 40 major subtypes, the most common types include indolent follicular lymphoma (FL) and aggressive diffuse large B-cell lymphoma (DLBCL). Each type is associated with unique driver genetic mutations (e.g., 14:18 translocation in FL, 11:14 translocation in Mantle Cell, 8:14 in Burkitts lymphoma ) and unique risk factors (Epstein-Barr Virus (EBV) for Burkitt's lymphoma, human T-cell lymphoma virus (HTLV-1) for T-cell lymphoma (de Leval et Jaffe,2020) The NOTCH gene was first named in studies of Drosophila melanogaster with notched wings in the 1910s, Homologs of NOTCH were then identified in multiple metazoans, and all these NOTCH homologs shared similar structures and signaling components.
- Being tested
- Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples.
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples.Diagnostic test
Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples.
What is being measured
The primary outcome is the main question the study is designed to answer.
-Detection of Notch1 mutation in BM or peripheral blood of of patients with NHL and patients with chronic lymphocytic leukemia . - Comparison between expression of mutation in patient with CLL and NHL using real time pcr
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)- Non-Hodgins's Lymphoma (NHL)Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayam Gamal Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157579
- Sponsor's protocol ID
- Soh-Med-25-8-2MD
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Notch 1 Mutation in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patient
- ClinicalTrials.gov ID
- NCT07157579
- Acronym / sponsor ID
- Soh-Med-25-8-2MD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Sep 2025 (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.
- Detection of Notch1 mutation in BM or peripheral blood of of patients with NHL
- Detection of Notch1 mutation in BM or peripheral blood of of patients with chronic lymphocytic leukemia .
- Comparison between expression of mutation in patient with CLL and NHL.
Detailed description
Chronic Lymphocytic Leukemia (CLL), is the most common leukemia in the western world. with a higher incidence in males (1.7:1),Current treatment strategies vary depending on disease burden, from active monitoring in asymptomatic patients, to targeted therapies in more advanced disease.
CLL is characterized by the clonal expansion of B cells with a characteristic immunophenotype (i.e., smIgweak, CD29+, CD23+, CD20weak) that slowly accumulate in peripheral blood, bone marrow, and lymphoid tissues mainly as a result of defects in the apoptosis machinery such as the overexpression of Bcl2 family anti-apoptotic proteins .
The clinical heterogeneity of CLL does reflect differences in the biology of the disease, particularly the IGHV mutational status and chromosomal alterations (i.e., del13q, del11q, trisomy 12 and del17p). Beside del17p/TP53 mutation which is the strongest CLL biomarker for response to therapy, other mutations (e.g., SF3B1, ATM, NOTCH1, BRIC3) have been reported to correlate with the outcome of the disease, but they are not actionable yet .
Non-Hodgins's lymphoma (NHL), the most common hematological malignancy worldwide, refers to a diverse class of B-cell and T-cell proliferations. NHL is differentiated from Hodgkin's lymphoma by different clinical characteristics and the absence of Reed-Sternberg cells and Cd15 and Cd30 staining on histology .
There are over 40 major subtypes, the most common types include indolent follicular lymphoma (FL) and aggressive diffuse large B-cell lymphoma (DLBCL). Each type is associated with unique driver genetic mutations (e.g., 14:18 translocation in FL, 11:14 translocation in Mantle Cell, 8:14 in Burkitts lymphoma ) and unique risk factors (Epstein-Barr Virus (EBV) for Burkitt's lymphoma, human T-cell lymphoma virus (HTLV-1) for T-cell lymphoma (de Leval et Jaffe,2020) The NOTCH gene was first named in studies of Drosophila melanogaster with notched wings in the 1910s, Homologs of NOTCH were then identified in multiple metazoans, and all these NOTCH homologs shared similar structures and signaling components.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The studied individuals will be classified into 2 groups: Group (I): represent available number of CLL cases Group (II): represents available number of NHL cases
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples.Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples. | Diagnostic test | – |
Primary outcome
-Detection of Notch1 mutation in BM or peripheral blood of of patients with NHL and patients with chronic lymphocytic leukemia . - Comparison between expression of mutation in patient with CLL and NHL using real time pcr
Time frame: baseline
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 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia (CLL)- Non-Hodgins's Lymphoma (NHL), run by Sohag University.
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 0 inclusion and 1 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hayam Gamal Ahmed (01093522899, drhayaa92@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Detection of Notch1 mutation in BM or peripheral blood of of patients with NHL and patients with chronic lymphocytic leukemia . - Comparison between expression of mutation in patient with CLL and NHL using real time pcr (time frame: baseline). 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 5 Sep 2025.