NCT07496827

Brief Summary

Haematological disorders represent a major global health concern due to their diverse causes, high morbidity, and significant mortality, and they include conditions such as anaemia, leukemia, lymphoma, myelodysplastic syndromes, and myeloma that disrupt vital functions like oxygen transport, immune defence, coagulation, and nutrient delivery (1). Anaemia is the most common haematological disorder worldwide, affecting about 1.8 billion people, with the greatest burden occurring in low- and middle-income countries (2). In the Mediterranean region, childhood anaemia prevalence is estimated at approximately 34.25%, although considerable regional variation exists (3). In Egypt, anaemia affects about 38.7% of adults, with significantly higher rates among females (53.8%) compared with males (23.3%) (4). Additionally, paediatric studies indicate that nearly two out of five young Egyptian children suffer from some degree of anaemia (5). Anaemia also contributes substantially to disability-adjusted life years (DALYs) through its negative effects on childhood development, maternal health, and economic productivity (6). Haematological malignancies represent another important global oncological challenge, with non-Hodgkin lymphoma ranking among the most common cancers in Egypt and leukemias affecting both adults and children (7). Treatment for these malignancies commonly involves intensive immunosuppressive therapies such as chemotherapy and stem cell transplantation, which increase susceptibility to opportunistic infections (8). Parasitic infections contribute to haematological disorders through several mechanisms, including chronic inflammation, disruption of haematopoiesis, and increased hepcidin expression that can lead to anemia of chronic disease (9). Intestinal helminths such as hookworms may also cause anaemia through chronic blood loss and impaired absorption of nutrients such as iron and vitamin B12 (10). Patients with haematological malignancies are particularly vulnerable to parasitic infections, including intestinal protozoa such as Cryptosporidium spp., Giardia intestinalis, Cystoisospora belli, and Blastocystis spp., which can act as opportunistic pathogens (11,12). In addition, Toxoplasma gondii infection is widespread globally and may contribute to anaemia and pose a higher risk for reactivation or severe infection in immunocompromised patients with haematological malignancies (13,14) The connection of high parasitic prevalence and direct haematopathological conditions highlights the necessity of integrative parasitic screening and targeted interventions in at-risk clinical populations.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Toxoplasma gondii seroprevalence

    Detection of Toxoplasma gondii seroprevalence in patients suffering from haematological disorders at Assiut University hospitals.

    baselines

Study Arms (3)

Group A (Anaemia):

Patients with confirmed anaemia (Hb \<11 g/dL in children ≤12 yrs; \<13 g/dL in men \>12 yrs; \<12 g/dL in nonpregnant women \>12 yrs) (15), without active malignancy.

Group B (Haematological Malignancy)

Patients with a confirmed diagnosis of leukemia, lymphoma, or multiple myeloma, irrespective of Hb level.

Group C (Control)

Apparently healthy individuals from the local community, without anemia or known immunosuppression.

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Group A: Meets WHO criteria for anaemia (15). d) Group B: Histologically/cytologically confirmed haematological malignancy. e) Group C: No clinical evidence of anaemia, haematological malignancy, or active systemic infection.

You may qualify if:

  • a) Aged ≥2 years. b) Provision of written informed consent (assent for minors). c) Group A: Meets WHO criteria for anaemia (15). d) Group B: Histologically/cytologically confirmed haematological malignancy. e) Group C: No clinical evidence of anaemia, haematological malignancy, or active systemic infection.

You may not qualify if:

  • a) Received antiparasitic medication within 4 weeks prior to enrollment. b) Received blood transfusion within 4 weeks prior to enrollment. c) Unable or unwilling to provide stool sample or blood specimen. d) Known HIV infection (due to fundamentally different immune pathophysiology).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university hospital

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03