Pediatric Hodgkin LymphomaNCT06340243
Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt
An observational study of Pediatric Hodgkin Lymphoma, run by Assiut University.
Trial summary
determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Hodgkin Lymphoma
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2026
- How long will I take part?
- 2 Years
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Infants and children around age of (1month to 18 years old) admitted with hodgkin lymphoma in a period of 2 years
Who may be able to join
- Previously untreated patients younger than 18 years old with classical Hodgkin lymphoma
Who cannot join
- Patients aged more than 18 years old.
- Patients who died early at presentation before starting chemotherapy
- diagnosis of nodular lymphocytic predominant Hodgkin lymphoma
- previous chemotherapy or radiotherapy other (simultaneous) malignancies
- severe concomitant diseases (eg, immune deficiency syndrome); or known HIV positive.
About this study
determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome
Read the detailed description
Hodgkin's lymphoma accounts for around 40% of all pediatric lymphomas and is the most prevalent cancer among adolescents and young adults. With combinations of chemotherapy and radiation, Hodgkin's lymphoma is roughly 80% curable, placing it among the most treatable cancers . Since the introduction of combination chemotherapy treatments 20 years ago, the prognosis for children with Hodgkin's lymphoma has improved. The treatment is mostly influenced by the stage of the disease at diagnosis, histology, existence of "B"-symptoms, and the presence of bulky disease. Nonetheless, 20% of patients do not achieve long-term remission, and around 20% experience treatment-related side effects such as secondary malignancies, infertility, cardiovascular disease, and organ malfunction following chemo-radiation .Studies of long-term therapy side effects were made possible by the significant number of survivors. The goal of therapy optimization protocols for pediatric patients with Hodgkin's lymphoma is to maintain excellent tumor control while limiting adverse effects and long-term consequences . It is critical to stratify patients based on reliable prognostic factors at presentation and according to the rapidity of response into low-risk (LR) patients who would benefit from less aggressive therapy, avoiding unnecessary toxic side effects, and high-risk (HR) patients who should be subjected to intensified therapy to reduce the rate of treatment failures and relapses .
- Conditions
- Pediatric Hodgkin Lymphoma
- Being tested
- radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy
determine if radiotherapy could be safely omitted for early responder patients without compromising outcome, it can be assessed by decrease in lymph node volume ,Volumes are approximated as ellipsoids. If a, b, c denote the principal axes of the ellipsoid the volume is calculated as V= (a x b x c)/2
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Hodgkin LymphomaStudies 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
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Saad Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340243
- Sponsor's protocol ID
- HODGKIN
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 1 Apr 2024
- 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 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt
- ClinicalTrials.gov ID
- NCT06340243
- Acronym / sponsor ID
- HODGKIN
- Conditions
- Pediatric Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 1 Apr 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.
determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome
Detailed description
Hodgkin's lymphoma accounts for around 40% of all pediatric lymphomas and is the most prevalent cancer among adolescents and young adults. With combinations of chemotherapy and radiation, Hodgkin's lymphoma is roughly 80% curable, placing it among the most treatable cancers . Since the introduction of combination chemotherapy treatments 20 years ago, the prognosis for children with Hodgkin's lymphoma has improved. The treatment is mostly influenced by the stage of the disease at diagnosis, histology, existence of "B"-symptoms, and the presence of bulky disease. Nonetheless, 20% of patients do not achieve long-term remission, and around 20% experience treatment-related side effects such as secondary malignancies, infertility, cardiovascular disease, and organ malfunction following chemo-radiation .Studies of long-term therapy side effects were made possible by the significant number of survivors. The goal of therapy optimization protocols for pediatric patients with Hodgkin's lymphoma is to maintain excellent tumor control while limiting adverse effects and long-term consequences . It is critical to stratify patients based on reliable prognostic factors at presentation and according to the rapidity of response into low-risk (LR) patients who would benefit from less aggressive therapy, avoiding unnecessary toxic side effects, and high-risk (HR) patients who should be subjected to intensified therapy to reduce the rate of treatment failures and relapses .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Infants and children around age of (1month to 18 years old) admitted with hodgkin lymphoma in a period of 2 years
Key inclusion criteria (1 listed)
- Previously untreated patients younger than 18 years old with classical Hodgkin lymphoma
Key exclusion criteria (5 listed)
- Patients aged more than 18 years old.
- Patients who died early at presentation before starting chemotherapy
- diagnosis of nodular lymphocytic predominant Hodgkin lymphoma
- previous chemotherapy or radiotherapy other (simultaneous) malignancies
- severe concomitant diseases (eg, immune deficiency syndrome); or known HIV positive.
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 |
|---|---|---|
| radiotherapyradiotherapy | Radiation | – |
Primary outcome
assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy
Time frame: 2 years
determine if radiotherapy could be safely omitted for early responder patients without compromising outcome, it can be assessed by decrease in lymph node volume ,Volumes are approximated as ellipsoids. If a, b, c denote the principal axes of the ellipsoid the volume is calculated as V= (a x b x c)/2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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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.
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 Pediatric Hodgkin 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 5 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 Apr 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?
Results are not available in the source record.
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?
assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy (time frame: 2 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 Apr 2024.