LymphomaNCT01639716
Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers
An observational study of Lymphoma, run by Nil Guler at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- newly diagnosed non hodgkin lymphoma
- Diffuse large B cell lymphoma and T cell lymphoma patients
Who cannot join
- under 18 age
- parasitosis
- allergic status
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Medical School
Samsun, Atakum, 55139
About this study
Official title: Aggressive Non-Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers
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.
- Conditions
- Lymphoma
- Keywords
- Survey, interleukin status
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lymphoma group | Not described | |
| healthy group | Not described | |
| IL-10 high | Not described | |
| IL-10 low | Not described | |
| IL-4 high | Not described | |
| IL-4 low | Not described | |
| lymphopenia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This study ended within 13 months
Secondary outcomes (1)
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.
Measured: During study which was 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nil Guler
- Responsible party
- Sponsor-investigator, Nil Guler, Guler, Nil, M.D.
- Investigators
- Nil Guler, MD, Principal investigatorNil Guler, MD, Principal investigator, ONDOKUZ MAYİS UNİVERSİTY, SCHOOL OF MEDİCİNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639716
- Sponsor's protocol ID
- NG63900
- Other IDs
- NG6420, NG6420
- Status last verified
- Jul 2012
- First submitted
- 4 Jul 2012
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Non-Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers
- ClinicalTrials.gov ID
- NCT01639716
- Acronym / sponsor ID
- NG63900
- Conditions
- Lymphoma
- Keywords
- Survey, interleukin status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Nil Guler
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Lymphoma group | – | – |
| healthy group | – | – |
| IL-10 high | – | – |
| IL-10 low | – | – |
| IL-4 high | – | – |
| IL-4 low | – | – |
| lymphopenia | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- newly diagnosed non hodgkin lymphoma
- Diffuse large B cell lymphoma and T cell lymphoma patients
Key exclusion criteria (3 listed)
- under 18 age
- parasitosis
- allergic status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interleukin 4 and Interleukin 10 levels as pg/mL in non hodgkin lymphoma
Time frame: This study ended within 13 months
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.
1 secondary outcome
survey as months
Time frame: During study which was 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- OMU School of Medicine. Contact via e-mail.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nil Guler, MD principal investigator
Nil Guler, MD principal investigator
ONDOKUZ MAYİS UNİVERSİTY, SCHOOL OF MEDİCİNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Nil Guler at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin 4 and Interleukin 10 levels as pg/mL in non hodgkin lymphoma (time frame: This study ended within 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.