Clinical trial NCT04893538: Prognostic Value Of Lymphocyte Count and Lymphocyte/ Monocyte Ratio in Patients With Hodgkin's Lymphoma
Official title: Prognostic Value Of Lymphocyte Count and Lymphocyte/ Monocyte Ratio in Patients With Hodgkin's Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin Lymphoma
Keywords: Lymphocyte count
International Prognostic Score
Lymphocyte/monocyte Ratio
Prognosis
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients newly diagnosed with Hodgkin's lymphoma at the Oncology Center of Tishreen University Hospital who have not yet received treatment

Brief summary: 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

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Therapeutic response
timeFrame: 6 months
measure: overall survival
timeFrame: 18 months
measure: progression free survival
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
affiliation: Tishreen University
name: FIRAS Hussain, Dr.
role: STUDY_CHAIR
affiliation: Tishreen University
name: Suzan Samra, Dr.
role: STUDY_DIRECTOR
affiliation: Tishreen University
name: Hasan Khalil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hancock BW, Dunsmore IR, Swan HT. Lymphopenia: a bad prognostic factor in Hodgkin's disease. Scand J Haematol. 1982 Sep;29(3):193-9.
citation: Hasenclever D, Diehl V. A prognostic score for advanced Hodgkin's disease. International Prognostic Factors Project on Advanced Hodgkin's Disease. N Engl J Med. 1998 Nov 19;339(21):1506-14. doi: 10.1056/NEJM199811193392104.
citation: Ayoub JP, Palmer JL, Huh Y, Cabanillas F, Younes A. Therapeutic and prognostic implications of peripheral blood lymphopenia in patients with Hodgkin's disease. Leuk Lymphoma. 1999 Aug;34(5-6):519-27. doi: 10.3109/10428199909058479.
citation: Porrata LF, Ristow K, Colgan JP, Habermann TM, Witzig TE, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Nowakowski GS, Thompson C, Markovic SN. Peripheral blood lymphocyte/monocyte ratio at diagnosis and survival in classical Hodgkin's lymphoma. Haematologica. 2012 Feb;97(2):262-9. doi: 10.3324/haematol.2011.050138. Epub 2011 Oct 11.
citation: Koh YW, Kang HJ, Park C, Yoon DH, Kim S, Suh C, Go H, Kim JE, Kim CW, Huh J. The ratio of the absolute lymphocyte count to the absolute monocyte count is associated with prognosis in Hodgkin's lymphoma: correlation with tumor-associated macrophages. Oncologist. 2012;17(6):871-80. doi: 10.1634/theoncologist.2012-0034. Epub 2012 May 15.
citation: Tadmor T, Polliack A. Lymphopenia a simple prognostic factor in lymphoma and other cancers: why not use it more as a guide? Leuk Lymphoma. 2010 Oct;51(10):1773-4. doi: 10.3109/10428194.2010.508825. No abstract available.