Prognostic Value Of Lymphocyte Count and Lymphocyte/ Monocyte Ratio in Patients With Hodgkin's Lymphoma

Tishreen University

Status: Unknown

Conditions: Hodgkin Lymphoma

Treatments: Diagnostic Test: First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: IPS > or = 3 and third analysis: Lymphocyte/Monocyte ratio < 2.9; Diagnostic Test: First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: IPS < 3 and third analysis: Lymphocyte/Monocyte ratio > or = 2.9

Study type: Observational

Funder types: Other

Identifiers

NCT04893538

Lymphopenia and Hodgkin

Details and patient eligibility

About

This study is to assess the utility of using Absolute Lymphocyte count, Lymphocyte/Monocyte Ratio and International Prognostic Scote at diagnosis in Hodgkin's Lymphoma as a prognostic predictor of therapeutic response, overall survival and progression free survival

Full description

Hodgkin's Lymphoma has a high cure rate even if patients do not complete their treatment, this proposes that some patients may experience overtreatment and that would have negative effects (such as cardiac toxicity, sterility, secondary malignancies...) which makes it imperative to search for prognostic predictor suitable for all stages of disease, knowing that the International Prognostic Score "IPS" is restricted to advanced stages of the disease.

Absolute Lymphocyte count reflects the immune status of the individuals. It has been shown that an individual's immune status controls the extent of his response treatment, overall survival and his progression free survival because of the role that Lymphocytes play in suppressing and eliminating tumor cells.

Tumor-Associated Macrophages "TAMs" have been shown to play a role in tumor growth and development. Also, it has been shown that an increase in peripheral Monocyte count is associated with an increase in TAMs, so that the Monocyte count may constitute an important prognostic predictor.

Combining the Lymphocyte count and the Monocyte count into one index may be better for estimating the prognosis.

The aim of this study is to determine the prognostic significance of Absolute Lymphocyte count "ALC", Lymphocyte/Monocyte Ratio "LMR" and International Prognostic Score "IPS" at the cut-off points: 1500 cells per microliter for ALC, 2.9 for LMR and Score=3 for IPS.

Investigators get these cut-off points by conducting a retrospective case-control study on previous patients in Oncology Center, Tishreen Hospital, Syria in 2020.

This study will be prospective cohort :

1. participants will be divided into two subgroups (patients have ALC >= 1500 cells per microliter and who have ALC < 1500 cells per microliter). Those two subgroups will be homogenized in terms of other prognostic factors using Propensity Score.
2. the same participants will be also divided into another two subgroups (who have IPS < 3 and who have IPS >=3) and Those two subgroups will be homogenized using Propensity Score.
3. Finally the same participants will be divided into two subgroups (who have LMR >= 2.9 and who have LMR < 2.9) and Those two subgroups will be homogenized as mentioned before.

Then Investigators will monitor the therapeutic response, overall survival and progression free survival for 18 months for each subgroup and compare these indexes to determine the effectiveness of each of them in each stage of the disease

Enrollment: 100 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed patients with Hodgkin's Lymphoma who have not yet received treatment
• Ages over 16 years old
• Signed informed consent before registration in study

Exclusion criteria

• Patients who have already received treatment
• Patients with a previous history of malignancy
• Patients with autoimmune diseases
• Patients with primary immunodeficiency
• AIDS patients
• Patients with acute or chronic infections
• Patients treated with drugs that affect the result of the analysis (Corticosteroids, Immunosuppressants, Li)

Trial design

100 participants in 2 patient groups

A

Description:

First analysis: Patients with high Lymphocyte count Second analysis: Patients with low International Prognosis Score Third analysis: Patients with high Lymphocyte/monocyte ratio

Treatment:

Diagnostic Test: First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: IPS < 3 and third analysis: Lymphocyte/Monocyte ratio > or = 2.9

B

Description:

First analysis: Patients with low Lymphocyte count Second analysis: Patients with high International Prognostic Score Third analysis: Patients with low Lymphocyte/monocyte ratio

Treatment:

Diagnostic Test: First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: IPS > or = 3 and third analysis: Lymphocyte/Monocyte ratio < 2.9