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Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers

Primary Purpose

Lymphoma

Status
Completed
Phase
Locations
Turkey
Study Type
Observational
Intervention
Sponsored by
Nil Guler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Lymphoma focused on measuring Survey, interleukin status

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • newly diagnosed non hodgkin lymphoma
  • Diffuse large B cell lymphoma and T cell lymphoma patients

Exclusion Criteria:

  • under 18 age
  • parasitosis
  • allergic status

Sites / Locations

  • Ondokuz Mayis University Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Arm Label

Lymphoma group

healthy group

IL-10 high

IL-10 low

IL-4 high

IL-4 low

lymphopenia

Arm Description

Outcomes

Primary Outcome Measures

Interleukin 4 and Interleukin 10 levels as pg/mL in non hodgkin lymphoma
We will measure 31 patients and 27 healthy person's Interleukin 4 and Interleukin 10 levels as pg/mL at the beginning of the study. We determined all of the patients IPI score, LDH (U/L), crp (mg/L), erythrocyte sedimentation rate, hemoglobin (gr/dL), lymphocyte count in per µL, albumin (gr/dL) before the treatment. We wanted to check whether there is any correlation between well known prognostic markers (LDH, crp, albumin, stage, ECOG performance status) and Interleukin-4 and interleukin-10 levels.

Secondary Outcome Measures

survey as months
Our secondary goal was to determine the survey time as month from diagnoses to die from any reason or last evaluation during our study which was 13 months.

Full Information

First Posted
July 4, 2012
Last Updated
July 12, 2012
Sponsor
Nil Guler
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1. Study Identification

Unique Protocol Identification Number
NCT01639716
Brief Title
Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers
Official Title
Aggressive Non-Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers
Study Type
Observational

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nil Guler

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesized that Non Hodgkin lymphoma is using T helper 2 pathways. So that the investigators decided to study of cytokines related to T helper 2 pathways. It is well known that parasites and allergic situations also use T helper 2 pathways. Because that the investigators excluded the patients have parasites and allergic situations. All the patients were over 18. The investigators included the patients with non Hodgkin lymphoma which new diagnosed. It is observational study. The investigators took blood before chemotherapy and four months later. The investigators did not interfere with which chemotherapy will be given to patients. This decision was belong to hematologist or oncologist who will treat the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Survey, interleukin status

7. Study Design

Enrollment
58 (Actual)
Biospecimen Retention
Samples Without DNA
Biospecimen Description
periperal blood sample

8. Arms, Groups, and Interventions

Arm Title
Lymphoma group
Arm Title
healthy group
Arm Title
IL-10 high
Arm Title
IL-10 low
Arm Title
IL-4 high
Arm Title
IL-4 low
Arm Title
lymphopenia
Primary Outcome Measure Information:
Title
Interleukin 4 and Interleukin 10 levels as pg/mL in non hodgkin lymphoma
Description
We will measure 31 patients and 27 healthy person's Interleukin 4 and Interleukin 10 levels as pg/mL at the beginning of the study. We determined all of the patients IPI score, LDH (U/L), crp (mg/L), erythrocyte sedimentation rate, hemoglobin (gr/dL), lymphocyte count in per µL, albumin (gr/dL) before the treatment. We wanted to check whether there is any correlation between well known prognostic markers (LDH, crp, albumin, stage, ECOG performance status) and Interleukin-4 and interleukin-10 levels.
Time Frame
This study ended within 13 months
Secondary Outcome Measure Information:
Title
survey as months
Description
Our secondary goal was to determine the survey time as month from diagnoses to die from any reason or last evaluation during our study which was 13 months.
Time Frame
During study which was 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: newly diagnosed non hodgkin lymphoma Diffuse large B cell lymphoma and T cell lymphoma patients Exclusion Criteria: under 18 age parasitosis allergic status
Study Population Description
31 newly diagnosed non hodgkin lymphoma and 27 healthy controls. We studied IL-10 and IL-4 in lymphoma group and healthy group and observed patients till end of study. We analised survival. We compared with IL-4 and IL-10 levels with prognostic factors.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nil Guler, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nil Guler, MD
Organizational Affiliation
ONDOKUZ MAYİS UNİVERSİTY, SCHOOL OF MEDİCİNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ondokuz Mayis University Medical School
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55139
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://www.omu.edu.tr
Description
OMU School of Medicine. Contact via e-mail.

Learn more about this trial

Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers

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