DLBCL - Diffuse Large B Cell LymphomaNCT07057765
Predictive Value of CRP, Albumin, CAR, and mGPS in Treatment Outcomes of DLBCL
An observational study of DLBCL - Diffuse Large B Cell Lymphoma and Markers of Inflammation, run by Ain Shams University at 1 site in Egypt.
Trial summary
This observational study evaluates the predictive value of systemic inflammatory markers-CRP, albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) receiving R-CHOP chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma, Markers of Inflammation
- What is being tested?
- Observational Assessment of Standard R-CHOP Treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment-naïve, pathologically confirmed DLBCL patients who will attend the Clinical Oncology and Nuclear Medicine Department until the target sample size is reached. All participants will receive standard treatment protocol (R-CHOP) after providing informed consent.
Who may be able to join
- Age ≥ 18 years and ≤ 65 years
- Pathologically confirmed, treatment-naïve diffuse large B-cell lymphoma (DLBCL)
- Any stage of disease (nodal or extra-nodal), with or without B symptoms
- Scheduled to receive standard systemic treatment (R-CHOP)
- ECOG performance status 0-2
- Baseline normal:
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- Complete blood count (CBC)
- Hepatitis viral markers
- Liver and renal function tests
- Urine analysis
- Echocardiogram
- Additional investigations to exclude current infection if clinically indicated
Who cannot join
- History of other concurrent or previous malignancies
- Relapsed or refractory DLBCL
- Uncontrolled comorbid conditions that may interfere with study participation, including:
- Diabetes mellitus
- Autoimmune diseases
- Active infections
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- Chronic inflammatory diseases
- Cardiac dysfunction
- Liver cell failure
- Pregnant females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate, 1181
Alaa M Elsayed, MSc, +20 111 249 0913, alaa.abdou@med.asu.edu.eg
Doaa A Mohamed, MD, Doaa.atef@med.asu.edu.eg
About this study
Official title: Predictive Value of CRP, Albumin, CAR, and mGPS in DLBCL: A Prospective Cohort Study on Treatment Outcomes and Toxicity
This observational study evaluates the predictive value of systemic inflammatory markers-CRP, albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) receiving R-CHOP chemotherapy. The study examines associations with treatment response, toxicity, and clinical characteristics.
Read the detailed description
This prospective cohort study investigates the predictive significance of systemic inflammatory markers-CRP, serum albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP chemotherapy. The study aims to assess correlations between these markers and treatment outcomes, including objective response rate (ORR) and treatment-related toxicity. Inflammatory markers will be measured at baseline and after three chemotherapy cycles. Treatment response will be evaluated using Lugano classification criteria, and toxicity will be assessed per CTCAE version 5.0. The study also explores associations with clinical characteristics such as disease stage and performance status, aiming to enhance prognostic modeling and support personalized treatment strategies in DLBCL.
- Being tested
- Observational Assessment of Standard R-CHOP Treatment
- Keywords
- DLBCL, CRP To Albumin Ratio, CAR, modified Glassgow Prognostic Score, mGPS
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Assessment of Standard R-CHOP TreatmentDrug
Patients will receive R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) as part of routine clinical care. The study does not assign or modify treatment. Data will be collected to assess the association between inflammatory markers and clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DLBCL Treated with R-CHOP (Observational Group) | Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who are receiving R-CHOP chemotherapy as part of standard clinical care. This observational study aims to evaluate the predictive value of baseline inflammatory markers (CRP, albumin, CAR, and mGPS) on treatment response and toxicity. No study-specific interventions are administered. Receives: Drug: Observational Assessment of Standard R-CHOP Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Following 3 Cycles of R-CHOP Based on Baseline Inflammatory Markers
Proportion ( %) of patients achieving an objective response (complete or partial) according to the Lugano classification after three cycles of R-CHOP chemotherapy. Patients will be stratified by baseline inflammatory markers:
- C-reactive protein (CRP, mg/L, measured by immunoturbidimetric assay)
- Serum albumin (g/dL, measured by colorimetric assay)
- CRP/Albumin ratio (CAR, calculated as CRP divided by albumin)
- Modified Glasgow Prognostic Score (mGPS, range 0-2) Response will be assessed using PET/CT imaging.
Measured: Baseline (Day 1 of Cycle 1) and Day 63 (End of Cycle 3; each cycle is 21 days)
Incidence of Treatment-Related Toxicity During Initial Treatment According to Baseline Inflammatory Markers
Incidence (%) of patients experiencing any-grade treatment-related adverse events during the first three cycles of R-CHOP, stratified by baseline CRP, albumin, CAR, and mGPS. Toxicity will be graded according to CTCAE version 5.0.
Measured: Day 1 of Cycle 1 through Day 63 (End of Cycle 3; each cycle is 21 days)
Secondary outcomes (1)
Proportion of Patients in Each IPI Risk Category by Baseline Inflammatory Marker Levels
Proportion (%) of patients in each International Prognostic Index (IPI) risk category (low, intermediate, high), stratified by baseline inflammatory markers:
- CRP (mg/L, measured by immunoturbidimetric assay)
- Albumin (g/dL, measured by colorimetric assay)
- CRP/Albumin ratio (CAR, calculated as CRP divided by albumin)
- Modified Glasgow Prognostic Score (mGPS, range 0-2) IPI will be calculated based on age, LDH level, Ann Arbor stage, ECOG performance status, and extranodal involvement.
Measured: Day 1 of Cycle 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start5 May 2025
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud M Ellithy, MD, Principal investigator, Faculty of Medicine, Ain Shams UniversityShaimaa A Pessar, MD, Study director, Faculty of Medicine, Ain Shams UniversityReham M Faheim, MD, Study director, Faculty of Medicine, Ain Shams UniversityDoaa A Mohamed, MD, Study director, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057765
- Sponsor's protocol ID
- FMASU MD104/2025
- Status last verified
- May 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the study is conducted within an academic setting and involves patient data that cannot be shared publicly due to confidentiality and ethical considerations."
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of CRP, Albumin, CAR, and mGPS in DLBCL: A Prospective Cohort Study on Treatment Outcomes and Toxicity
- ClinicalTrials.gov ID
- NCT07057765
- Acronym / sponsor ID
- FMASU MD104/2025
- Keywords
- DLBCL, CRP To Albumin Ratio, CAR, modified Glassgow Prognostic Score, mGPS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 10 Jul 2025 (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.
This observational study evaluates the predictive value of systemic inflammatory markers-CRP, albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) receiving R-CHOP chemotherapy. The study examines associations with treatment response, toxicity, and clinical characteristics.
Detailed description
This prospective cohort study investigates the predictive significance of systemic inflammatory markers-CRP, serum albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP chemotherapy. The study aims to assess correlations between these markers and treatment outcomes, including objective response rate (ORR) and treatment-related toxicity. Inflammatory markers will be measured at baseline and after three chemotherapy cycles. Treatment response will be evaluated using Lugano classification criteria, and toxicity will be assessed per CTCAE version 5.0. The study also explores associations with clinical characteristics such as disease stage and performance status, aiming to enhance prognostic modeling and support personalized treatment strategies in DLBCL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DLBCL Treated with R-CHOP (Observational Group) | – | Drug: Observational Assessment of Standard R-CHOP TreatmentPatients diagnosed with diffuse large B-cell lymphoma (DLBCL) who are receiving R-CHOP chemotherapy as part of standard clinical care. This observational study aims to evaluate the predictive value of baseline inflammatory markers (CRP, albumin, CAR, and mGPS) on treatment response and toxicity. No study-specific interventions are administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naïve, pathologically confirmed DLBCL patients who will attend the Clinical Oncology and Nuclear Medicine Department until the target sample size is reached. All participants will receive standard treatment protocol (R-CHOP) after providing informed consent.
Key inclusion criteria (12 listed)
- Age ≥ 18 years and ≤ 65 years
- Pathologically confirmed, treatment-naïve diffuse large B-cell lymphoma (DLBCL)
- Any stage of disease (nodal or extra-nodal), with or without B symptoms
- Scheduled to receive standard systemic treatment (R-CHOP)
- ECOG performance status 0-2
Key exclusion criteria (10 listed)
- History of other concurrent or previous malignancies
- Relapsed or refractory DLBCL
- Uncontrolled comorbid conditions that may interfere with study participation, including:
- Diabetes mellitus
- Autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Assessment of Standard R-CHOP TreatmentPatients will receive R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) as part of routine clinical care. The study does not assign or modify treatment. Data will be collected to assess the association between inflammatory markers and clinical outcomes. | Drug | Patients with DLBCL Treated with R-CHOP (Observational Group) |
Primary outcome
Objective Response Rate (ORR) Following 3 Cycles of R-CHOP Based on Baseline Inflammatory Markers
Time frame: Baseline (Day 1 of Cycle 1) and Day 63 (End of Cycle 3; each cycle is 21 days)
Proportion ( %) of patients achieving an objective response (complete or partial) according to the Lugano classification after three cycles of R-CHOP chemotherapy. Patients will be stratified by baseline inflammatory markers: * C-reactive protein (CRP, mg/L, measured by immunoturbidimetric assay) * Serum albumin (g/dL, measured by colorimetric assay) * CRP/Albumin ratio (CAR, calculated as CRP divided by albumin) * Modified Glasgow Prognostic Score (mGPS, range 0-2) Response will be assessed using PET/CT imaging.
Incidence of Treatment-Related Toxicity During Initial Treatment According to Baseline Inflammatory Markers
Time frame: Day 1 of Cycle 1 through Day 63 (End of Cycle 3; each cycle is 21 days)
Incidence (%) of patients experiencing any-grade treatment-related adverse events during the first three cycles of R-CHOP, stratified by baseline CRP, albumin, CAR, and mGPS. Toxicity will be graded according to CTCAE version 5.0.
1 secondary outcome
Proportion of Patients in Each IPI Risk Category by Baseline Inflammatory Marker Levels
Time frame: Day 1 of Cycle 1 (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No. Because the study is conducted within an academic setting and involves patient data that cannot be shared publicly due to confidentiality and ethical considerations."
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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.
Mahmoud M Ellithy, MD principal investigator
Faculty of Medicine, Ain Shams University
Shaimaa A Pessar, MD study director
Faculty of Medicine, Ain Shams University
Reham M Faheim, MD study director
Faculty of Medicine, Ain Shams 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 DLBCL - Diffuse Large B Cell Lymphoma and Markers of Inflammation, run by Ain Shams University at 1 site in Egypt.
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 12 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa M Elsayed, MSc (+201112490913, alaa.abdou@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Following 3 Cycles of R-CHOP Based on Baseline Inflammatory Markers (time frame: Baseline (Day 1 of Cycle 1) and Day 63 (End of Cycle 3; each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 10 Jul 2025.