Haematological DisordersNCT07496827
Detection of Parasitic Infections in Patients With Haematological Disorders in Assiut University Hospitals
An observational study of Haematological Disorders, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Haematological Disorders
- How many people
- 285 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2027
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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).
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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.
- Conditions
- Haematological Disorders
- Medical subject headings
- Hematologic Diseases
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxoplasma gondii seroprevalence
Detection of Toxoplasma gondii seroprevalence in patients suffering from haematological disorders at Assiut University hospitals.
Measured: baselines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological DisordersStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reem samir yehia saleh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496827
- Sponsor's protocol ID
- Parasitic Infecti Haematology
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Parasitic Infections in Patients With Haematological Disorders in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT07496827
- Acronym / sponsor ID
- Parasitic Infecti Haematology
- Conditions
- Haematological Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
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
Toxoplasma gondii seroprevalence
Time frame: baselines
Detection of Toxoplasma gondii seroprevalence in patients suffering from haematological disorders at Assiut University hospitals.
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 27 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Haematological Disorders, run by Assiut University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Toxoplasma gondii seroprevalence (time frame: baselines). 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 27 Mar 2026.