Notch 1 Mutation in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patient

August 27, 2025 updated by: Hayam Gamal Ahmed, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

IncluInclusion criteria: approval to sign an informed written consent, patient with NHL and CLL .

Exclusion Criteria:

Refusal to sign an informed written consent, patient on chemotherapy sion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
-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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 18, 2025

First Submitted That Met QC Criteria

August 27, 2025

First Posted (Estimated)

September 5, 2025

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-25-8-2MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia (CLL)- Non-Hodgins's Lymphoma (NHL)

Clinical Trials on Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe