Haematologic NeoplasmNCT06402175
Characteristics and Outcomes of Patients With Hematological Malignancies
An observational study of Haematologic Neoplasm, run by Assiut University.
Trial summary
The pattern of hematological malignancies (HMs) in developing countries and developed countries differs. Among the different types of cancers, leukemia, lymphoma, and multiple myeloma appear to have greatly increased in frequency. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Haematologic Neoplasm
- What is being tested?
- follow up
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Apr 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: follow up of hematological malignancy
Who may be able to join
- Adult patients of Hematological malignancies (≥18 years)
Who cannot join
- patients who have started diagnosis and treatment for malignancy outside Assiut university.
- Age less than 18 years
About this study
Official title: Characteristics and Outcomes of Patients With Hematological Malignancies at Main Assuit University Hospital : A Single Centre Study
The pattern of hematological malignancies (HMs) in developing countries and developed countries differs. Among the different types of cancers, leukemia, lymphoma, and multiple myeloma appear to have greatly increased in frequency.
Read the detailed description
The pattern of hematological malignancies (HMs) in developing countries and developed countries differs. Among the different types of cancers, leukemia, lymphoma, and multiple myeloma appear to have greatly increased in frequency. These malignancies are induced by genetic damage or mutation in somatic cells, which can result from environmental exposure to chemicals, ionizing radiation, and viral agents. Comparison of the incidence of HMs across geographic regions and time is complicated by the existence of different disease classification systems, and diagnostic criteria that vary by country, and even between hospitals and cancer registries (CRs) within a country.
Leukemia is a malignant neoplasm of hematopoietic stem cells characterized by diffuse replacement of bone marrow or peripheral blood by neoplastic cells; its etiology is obscure. Leukemia typing is based on how quickly the disease develops and progresses. Leukemia is either chronic or acute. Furthermore, leukemia typing is also based on the type of white blood cell that is affected. There are 4 common types of leukemia: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). Most acute leukemias are classified as lymphoid or myeloid lineages via standard microscopic morphology, cytochemistry, and immunophenotyping. Previous studies have shown that there are important differences in the incidence of the various leukemia subtypes according to geography, race/ethnicity, age, and trend pattern, indicating that the subtypes may have different etiological factors and that comprehensive global assessment of leukemia patterns is warranted.
Lymphomas are a heterogenous group of diseases with differences in epidemiology, histology, and prognosis. The incidence of Hodgkin's lymphoma (HL) and nonHodgkin's lymphoma (NHL) is higher among males than females.
Multiple myeloma (MM) is included in the spectrum of diseases ranging from monoclonal gammopathy of unknown significance (MGUS) to plasma cell leukemia. Plasma cell proliferation usually results in extensive skeletal destruction, with osteolytic lesions, hypercalcemia, anemia, and occasionally plasma cell infiltration in different organs. Excessive production of a monoclonal (M) protein can lead to renal failure, hyperviscosity syndrome, or recurrent bacterial infections.
- Conditions
- Haematologic Neoplasm
- Being tested
- follow up
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow upOther
follow up
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate
Assessment of overall survival of hematological malignancies at Assiut university Hospital
- Estimate rate of non-relapse mortality.
- Estimate rate of complete remission.
- Estimate rate of refractory disease.
- Estimate the rate of relapsed diseases.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematologic NeoplasmStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelslam Abudeif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402175
- Sponsor's protocol ID
- Assiut Univesity
- Status last verified
- Jun 2024
- First submitted
- 20 Apr 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of Patients With Hematological Malignancies at Main Assuit University Hospital : A Single Centre Study
- ClinicalTrials.gov ID
- NCT06402175
- Acronym / sponsor ID
- Assiut Univesity
- Conditions
- Haematologic Neoplasm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 7 May 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.
The pattern of hematological malignancies (HMs) in developing countries and developed countries differs. Among the different types of cancers, leukemia, lymphoma, and multiple myeloma appear to have greatly increased in frequency.
Detailed description
The pattern of hematological malignancies (HMs) in developing countries and developed countries differs. Among the different types of cancers, leukemia, lymphoma, and multiple myeloma appear to have greatly increased in frequency. These malignancies are induced by genetic damage or mutation in somatic cells, which can result from environmental exposure to chemicals, ionizing radiation, and viral agents. Comparison of the incidence of HMs across geographic regions and time is complicated by the existence of different disease classification systems, and diagnostic criteria that vary by country, and even between hospitals and cancer registries (CRs) within a country.
Leukemia is a malignant neoplasm of hematopoietic stem cells characterized by diffuse replacement of bone marrow or peripheral blood by neoplastic cells; its etiology is obscure. Leukemia typing is based on how quickly the disease develops and progresses. Leukemia is either chronic or acute. Furthermore, leukemia typing is also based on the type of white blood cell that is affected. There are 4 common types of leukemia: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). Most acute leukemias are classified as lymphoid or myeloid lineages via standard microscopic morphology, cytochemistry, and immunophenotyping. Previous studies have shown that there are important differences in the incidence of the various leukemia subtypes according to geography, race/ethnicity, age, and trend pattern, indicating that the subtypes may have different etiological factors and that comprehensive global assessment of leukemia patterns is warranted.
Lymphomas are a heterogenous group of diseases with differences in epidemiology, histology, and prognosis. The incidence of Hodgkin's lymphoma (HL) and nonHodgkin's lymphoma (NHL) is higher among males than females.
Multiple myeloma (MM) is included in the spectrum of diseases ranging from monoclonal gammopathy of unknown significance (MGUS) to plasma cell leukemia. Plasma cell proliferation usually results in extensive skeletal destruction, with osteolytic lesions, hypercalcemia, anemia, and occasionally plasma cell infiltration in different organs. Excessive production of a monoclonal (M) protein can lead to renal failure, hyperviscosity syndrome, or recurrent bacterial infections.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- follow up of hematological malignancy
Key inclusion criteria (1 listed)
- Adult patients of Hematological malignancies (≥18 years)
Key exclusion criteria (2 listed)
- patients who have started diagnosis and treatment for malignancy outside Assiut university.
- Age less than 18 years
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 |
|---|---|---|
| follow upfollow up | Other | – |
Primary outcome
overall survival rate
Time frame: 5 years
Assessment of overall survival of hematological malignancies at Assiut university Hospital * Estimate rate of non-relapse mortality. * Estimate rate of complete remission. * Estimate rate of refractory disease. * Estimate the rate of relapsed diseases.
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 5 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Haematologic Neoplasm
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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 Haematologic Neoplasm, 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 2 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 5 Jun 2024. 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?
overall survival rate (time frame: 5 years). 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 5 Jun 2024.