Hodgkin LymphomaNCT06564259
Relationship Between Serum β2-Microglobulin and Infiltration of CD8+ in the Tumor Tissue of Hodgkin's Lymphoma Patients
An observational study of Hodgkin Lymphoma, run by Latakia University at 1 site in Syria.
Trial summary
In newly diagnosed Hodgkin lymphoma patients, pre-treatment Beta-2 Microglobulin (B2M) levels will be measured. A thorough baseline assessment will be performed using CT imaging, and tumor tissue samples will be collected for Immunohistochemical (IHC) analysis to quantify CD8+ cell infiltration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkin Lymphoma
- How many people
- 144 participants
- Where
- 1 siteSyria
- Study dates
- 4 Jan 2024to 15 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study included a cohort of 144 patients newly diagnosed with Hodgkin lymphoma. Patients were between the ages of 14 and 71 years, with an almost balanced representation of both genders. All participants had a confirmed Hodgkin lymphoma diagnosis based on histopathological examination. The study population reflected a diverse range of disease stages and subtypes, providing a comprehensive understanding of the relationship between pre-treatment Beta-2 Microglobulin (B2M) levels, CD8+ cell infiltration, and chemotherapy response in this patient population.
Who may be able to join
- Newly diagnosed patients with Hodgkin lymphoma
- No prior history of malignancy
- Absence of primary or secondary immunodeficiencies
Who cannot join
- Patients who have previously undergone treatment
- Patients with acute or chronic infections
- Patients with renal disorders
- Individuals with autoimmune diseases
- HIV-positive patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Serum Beta-2 Microglobulin (sB2M) Levels and CD8+ Cell Infiltration in Hodgkin Lymphoma Tissues: Impact on Chemotherapy Outcomes
In newly diagnosed Hodgkin lymphoma patients, pre-treatment Beta-2 Microglobulin (B2M) levels will be measured. A thorough baseline assessment will be performed using CT imaging, and tumor tissue samples will be collected for Immunohistochemical (IHC) analysis to quantify CD8+ cell infiltration. Patients will be closely monitored throughout their treatment, with a follow-up CT scan at the end of therapy to evaluate therapeutic response. This study aims to investigate the correlation between pre-treatment B2M levels and CD8+ immune cell infiltration in tumor tissues, assessing their potential as predictive markers for chemotherapy response.
- Conditions
- Hodgkin Lymphoma
- Keywords
- serum Beta-2 Microglobulin, CD8+ cells, Hodgkin lymphoma, Predictive value, Chemotherapy.
- Medical subject headings
- Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic response
Achieving complete remission after chemotherapy
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start4 Jan 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Firas Hussien, Prof., Study chair, Latakia UniversityMaram Bilal, Prof., Study director, Latakia UniversityHasan Khalil, Ms, Principal investigator, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564259
- Sponsor's protocol ID
- 1839
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum Beta-2 Microglobulin (sB2M) Levels and CD8+ Cell Infiltration in Hodgkin Lymphoma Tissues: Impact on Chemotherapy Outcomes
- ClinicalTrials.gov ID
- NCT06564259
- Acronym / sponsor ID
- 1839
- Conditions
- Hodgkin Lymphoma
- Keywords
- serum Beta-2 Microglobulin, CD8+ cells, Hodgkin lymphoma, Predictive value, Chemotherapy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 21 Aug 2024 (actual)
- 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.
In newly diagnosed Hodgkin lymphoma patients, pre-treatment Beta-2 Microglobulin (B2M) levels will be measured. A thorough baseline assessment will be performed using CT imaging, and tumor tissue samples will be collected for Immunohistochemical (IHC) analysis to quantify CD8+ cell infiltration. Patients will be closely monitored throughout their treatment, with a follow-up CT scan at the end of therapy to evaluate therapeutic response. This study aims to investigate the correlation between pre-treatment B2M levels and CD8+ immune cell infiltration in tumor tissues, assessing their potential as predictive markers for chemotherapy response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included a cohort of 144 patients newly diagnosed with Hodgkin lymphoma. Patients were between the ages of 14 and 71 years, with an almost balanced representation of both genders. All participants had a confirmed Hodgkin lymphoma diagnosis based on histopathological examination. The study population reflected a diverse range of disease stages and subtypes, providing a comprehensive understanding of the relationship between pre-treatment Beta-2 Microglobulin (B2M) levels, CD8+ cell infiltration, and chemotherapy response in this patient population.
Key inclusion criteria (3 listed)
- Newly diagnosed patients with Hodgkin lymphoma
- No prior history of malignancy
- Absence of primary or secondary immunodeficiencies
Key exclusion criteria (5 listed)
- Patients who have previously undergone treatment
- Patients with acute or chronic infections
- Patients with renal disorders
- Individuals with autoimmune diseases
- HIV-positive patients
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
Therapeutic response
Time frame: 2-4 months
Achieving complete remission after chemotherapy
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 21 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
Firas Hussien, Prof. study chair
Latakia University
Maram Bilal, Prof. study director
Latakia University
Hasan Khalil, Ms principal investigator
Latakia University
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 Hodgkin Lymphoma, run by Latakia University at 1 site in Syria.
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 3 inclusion and 5 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 21 Aug 2024. 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 Syria. 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?
Therapeutic response (time frame: 2-4 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 21 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.