Using blood inflammation markers (CRP, albumin, CAR, mGPS) to predict outcomes in diffuse large B‑cell lymphoma
Predictive Value of CRP, Albumin, CAR, and mGPS in DLBCL: A Prospective Cohort Study on Treatment Outcomes and Toxicity
This project tests whether common blood inflammation markers (CRP, albumin, CRP-to-albumin ratio, and mGPS) can help predict how adults with newly diagnosed DLBCL will respond to standard R-CHOP chemotherapy and what side effects they may get.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07057765 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of adults with treatment‑naïve diffuse large B‑cell lymphoma receiving standard R‑CHOP chemotherapy at Ain Shams University. Investigators will measure CRP, serum albumin, the CRP‑to‑albumin ratio (CAR), and the modified Glasgow Prognostic Score (mGPS) at baseline and after three cycles of treatment. Treatment response will be classified by Lugano criteria and toxicity graded by CTCAE v5.0, with comparisons made between marker levels and outcomes including objective response rate and treatment‑related toxicity. The study also examines how these markers relate to clinical features such as stage and performance status to inform prognostic models.
Who should consider this trial
Good fit: Adults aged 18–65 with newly diagnosed, treatment‑naïve DLBCL who are planned for standard R‑CHOP, have ECOG performance status 0–2, and normal baseline labs are the intended participants.
Not a fit: Patients with relapsed or refractory DLBCL, concurrent or prior other malignancies, uncontrolled comorbidities (including diabetes, autoimmune or chronic inflammatory diseases, active infections, cardiac or liver failure), or pregnancy are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, these routinely measured blood markers could help clinicians better predict which patients are likely to respond to R‑CHOP and tailor monitoring or treatment intensity.
How similar studies have performed: Previous observational studies in DLBCL and other cancers have reported associations between CRP, albumin, CAR, mGPS and outcomes, but findings are not yet definitive enough to change standard care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: * Complete blood count (CBC) * Hepatitis viral markers * Liver and renal function tests * Urine analysis * Echocardiogram * Additional investigations to exclude current infection if clinically indicated Exclusion Criteria: * 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 * Chronic inflammatory diseases * Cardiac dysfunction * Liver cell failure * Pregnant females
Where this trial is running
Cairo, Cairo Governorate
- Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Ain Shams University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Mahmoud M Ellithy, MD — Faculty of Medicine, Ain Shams University
- Study coordinator: Alaa M Elsayed, MSc
- Email: alaa.abdou@med.asu.edu.eg
- Phone: +201112490913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.