ElastographyNCT05967975
Elastography and Treatment of Lymphoma
An observational study of Elastography and Lymphoma, run by Assiut University.
Trial summary
To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Elastography, Lymphoma
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed as lymphoma , have superficial lymph nodes and not received any treatment
Who may be able to join
- patients who are histopathologically proven as lymphoma, not receive treatment and have superficial lymphadenopathy.
Who cannot join
- 1-Lymphoma without superficial lymph nodes. 2-patients under treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Sonoelastography in Evaluation of Therapeutic Response in Patients With Lymphoma.
To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.
Read the detailed description
Lymphomas are a heterogeneous group of malignancies that arise from the clonal proliferation of lymphocytes. It represents approximately 5% of malignancies. Overall survival is estimated to be 72%. (1)
Lymphomas are broadly classified into Hodgkin lymphoma (HL) (10%) and Non-Hodgkin lymphoma (NHL) (90%).
HL is further classified into classical and non-classical types and NHL into B-cell, T-cell and natural killer (NK) cell types. Diagnosis of lymphoma is confirmed by histopathology (FNAC, True-cut or excisional biopsy).(2) The standard treatment of lymphoma is chemotherapy and radiotherapy.
The modalities used for staging and follow up of lymphoma are:
- Computed Tomography (CT) chest, abdomen and pelvis.
- Positron Emission Tomography (PET/CT).
- Whole body Magnetic Resonance Imaging (MRI).(3)
Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. To the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.(4)
- Conditions
- Elastography, Lymphoma
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.
Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. To the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.
Measured: Average three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElastographyStudies 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
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerols Refaat Ayoub, Assiut University
- Investigators
- Kerols Refaat, Resident, Principal investigator, Assiut UniversityNagham Nabil, Professor, Study director, Assiut UniversityAbdel-Monem Sayed, Lecture, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967975
- Sponsor's protocol ID
- Elastography and lymphoma
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sonoelastography in Evaluation of Therapeutic Response in Patients With Lymphoma.
- ClinicalTrials.gov ID
- NCT05967975
- Acronym / sponsor ID
- Elastography and lymphoma
- Conditions
- Elastography, Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (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.
To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.
Detailed description
Lymphomas are a heterogeneous group of malignancies that arise from the clonal proliferation of lymphocytes. It represents approximately 5% of malignancies. Overall survival is estimated to be 72%. (1)
Lymphomas are broadly classified into Hodgkin lymphoma (HL) (10%) and Non-Hodgkin lymphoma (NHL) (90%).
HL is further classified into classical and non-classical types and NHL into B-cell, T-cell and natural killer (NK) cell types. Diagnosis of lymphoma is confirmed by histopathology (FNAC, True-cut or excisional biopsy).(2) The standard treatment of lymphoma is chemotherapy and radiotherapy.
The modalities used for staging and follow up of lymphoma are:
- Computed Tomography (CT) chest, abdomen and pelvis.
- Positron Emission Tomography (PET/CT).
- Whole body Magnetic Resonance Imaging (MRI).(3)
Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. To the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.(4)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed as lymphoma , have superficial lymph nodes and not received any treatment
Key inclusion criteria (1 listed)
- patients who are histopathologically proven as lymphoma, not receive treatment and have superficial lymphadenopathy.
Key exclusion criteria (1 listed)
- 1-Lymphoma without superficial lymph nodes. 2-patients under treatment.
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
To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.
Time frame: Average three years
Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. To the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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. This study is not recruiting at the moment.
Kerols Refaat, Resident principal investigator
Assiut University
Nagham Nabil, Professor study director
Assiut University
Abdel-Monem Sayed, Lecture study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Elastography and Lymphoma, 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kero Refaat, Resident (+2 01110134427, kerolsrefaat13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma. (time frame: Average three 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 1 Aug 2023.