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

NCT04893538 | Unknown DMC

• 1 other identifier: Lymphopenia and Hodgkin
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Hodgkin Lymphoma

Keywords

Lymphocyte count; International Prognostic Score; Lymphocyte/monocyte Ratio; Prognosis

Outcome Measures

Primary Outcomes (3)

• Therapeutic response

  Achieve complete remission after completing the prescribed treatment plan

  6 months

• overall survival

  The occurrence of death after acceptance to study

  18 months

• progression free survival

  The occurrence of relapse after acceptance to study

  18 months

Study Arms (2)

A

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

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

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

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

Interventions

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

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

A

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

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University

Latakia, Syria

RECRUITING

Related Publications (6)

• Hancock BW, Dunsmore IR, Swan HT. Lymphopenia: a bad prognostic factor in Hodgkin's disease. Scand J Haematol. 1982 Sep;29(3):193-9.

  PMID: 7146822 BACKGROUND

• 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.

  PMID: 9819449 BACKGROUND

• 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.

  PMID: 10492075 BACKGROUND

• 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.

  PMID: 21993683 BACKGROUND

• 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.

  PMID: 22588324 BACKGROUND

• 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.

  PMID: 20849382 BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• FIRAS Hussain, Dr.

  Tishreen University

  STUDY CHAIR

• Suzan Samra, Dr.

  Tishreen University

  STUDY DIRECTOR

• Hasan Khalil

  Tishreen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Khalil, Dr.

CONTACT

00963992869604; hsnkhal@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 19, 2021
• Study Start: January 4, 2021
• Primary Completion: June 21, 2022
• Study Completion: July 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SY (1)