Prognostic Value Of Lymphocyte Count and Lymphocyte/ Monocyte Ratio in Patients With Hodgkin's Lymphoma
NCT ID: NCT04893538
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-01-04
2022-07-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A
First analysis: Patients with high Lymphocyte count Second analysis: Patients with low International Prognosis Score Third analysis: Patients with high Lymphocyte/monocyte ratio
First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: IPS < 3 and third analysis: Lymphocyte/Monocyte ratio > or = 2.9
Intravenous blood sampling from participants for complete blood count to obtain Lymphocyte count, Monocyte count and Lymphocyte/Monocyte Ratio and for plasma Albumin to obtain IPS
B
First analysis: Patients with low Lymphocyte count Second analysis: Patients with high International Prognostic Score Third analysis: Patients with low Lymphocyte/monocyte ratio
First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: IPS > or = 3 and third analysis: Lymphocyte/Monocyte ratio < 2.9
Intravenous blood sampling from participants for complete blood count to obtain Lymphocyte count, Monocyte count and Lymphocyte/Monocyte Ratio and for plasma Albumin to obtain IPS
Interventions
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First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: IPS < 3 and third analysis: Lymphocyte/Monocyte ratio > or = 2.9
Intravenous blood sampling from participants for complete blood count to obtain Lymphocyte count, Monocyte count and Lymphocyte/Monocyte Ratio and for plasma Albumin to obtain IPS
First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: IPS > or = 3 and third analysis: Lymphocyte/Monocyte ratio < 2.9
Intravenous blood sampling from participants for complete blood count to obtain Lymphocyte count, Monocyte count and Lymphocyte/Monocyte Ratio and for plasma Albumin to obtain IPS
Eligibility Criteria
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Inclusion Criteria
* Ages over 16 years old
* Signed informed consent before registration in study
Exclusion Criteria
* 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)
15 Years
ALL
No
Sponsors
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Tishreen University
OTHER
Responsible Party
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Principal Investigators
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FIRAS Hussain, Dr.
Role: STUDY_CHAIR
Tishreen University
Suzan Samra, Dr.
Role: STUDY_DIRECTOR
Tishreen University
Hasan Khalil
Role: PRINCIPAL_INVESTIGATOR
Tishreen University
Locations
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Tishreen University
Latakia, , Syria
Countries
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Central Contacts
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Facility Contacts
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References
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Hancock BW, Dunsmore IR, Swan HT. Lymphopenia: a bad prognostic factor in Hodgkin's disease. Scand J Haematol. 1982 Sep;29(3):193-9.
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.
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.
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.
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.
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.
Other Identifiers
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Lymphopenia and Hodgkin
Identifier Type: -
Identifier Source: org_study_id
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