Clinico-hematological and Molecular Characteristics of Chronic Lymphocytic Leukemia Patients

NCT07162532 | Not Yet Recruiting

• 1 other identifier: molecular characters of CLL
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

the goal of this study is To describe the clinical, hematologic, and cytogenetic characteristics of CLL cases. The main questions it aims to answer are:

1. 1.what is the impact of cytogenetics abnormalities \[e.g., IGHV mutation status, del(17p)\] on patients' treatment response?
2. 2.what is th correlation between clinical and hematological characteristic with patients' outcome.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Outcome Measures

Primary Outcomes (1)

• 1)A detailed profile of genetic characteristics in CLL patients . 2)Identification of relation between IGHV Mutation and treatment response.(complete remission,partial remission,stable disease,progressive disease and minimal residual disease response)

  1 year

Interventions

1 Complete blood picture (CBC) with blood film, lymphocytic count 2 and viral hepatitis 3 Immunophenotyping 4 LDH 5 Coomb's tests ,deletion 17p,IGVH mutation,ESR DIAGNOSTIC_TEST

Complete blood picture (CBC) with blood film, lymphocytic count 2 Routine liver and kidney function and viral hepatitis 3 Immunophenotyping 4 LDH 5 Coomb's tests 6 Erythrocyte sedimentation rate (ESR). 7 C reactive protein (CRP). 8 Cytogenetic profiles: del(17p) 9 molecular study :IGHV mutation status.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Age ≥ 18 years newly diagnosed with CLL. 2. Adequate diagnostics (flowcytometry and cytogenetics) and follow-up data (at least 1 year). 3. Patients giving informed consent.

You may qualify if:

• Age ≥ 18 years newly diagnosed with CLL.
• Adequate diagnostics (flowcytometry and cytogenetics) and follow-up data (at least 1 year).
• Patients giving informed consent.

You may not qualify if:

• Incomplete diagnostics (e.g. flowcytometry of cytogenetics)
• Lost to follow-up within 12 months of diagnosis.
• Refused to give informed consent

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Chiorazzi N, Rai KR, Ferrarini M. Chronic lymphocytic leukemia. N Engl J Med. 2005 Feb 24;352(8):804-15. doi: 10.1056/NEJMra041720. No abstract available.

  PMID: 15728813 BACKGROUND

• Korsholm C, Bulow C, Christensen M, Dalhoff K, Feinberg JB, Lund TM, Niemann CU, Petersen TS, Andersen MA. Drug exposure and measurable residual disease in chronic lymphocytic leukemia: a systematic review. Leuk Lymphoma. 2025 Feb;66(2):229-239. doi: 10.1080/10428194.2024.2412289. Epub 2024 Nov 7.

  PMID: 39509142 BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Mai Mostafa Mohamed, MD

  assuit univeristy hospitals

  STUDY DIRECTOR

• Mohamed Ramadan Abdel-Hameed, MD

  assuit univeristy hospitals

  STUDY DIRECTOR

Central Study Contacts

sawsan abdellah abdelaal, master degree

CONTACT

00201032203190; sawsan.abdellah@yahoo.com

Mai Mostafa Mohamed, MD

CONTACT

00201223971678; maialy24983@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of clinical hematology

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-07