Hodgkin LymphomaNCT06761599
Frequency of Pulmonary Toxicity in Patients Treated for Hodgkin Lymphoma
An observational study of Hodgkin Lymphoma, run by Superior University at 1 site in Pakistan.
Trial summary
Pulmonary toxicity during Hodgkin lymphoma treatment is significant for a variety of reasons, ranging from clinical care to therapeutic innovation and patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- group 1
- How many people
- 214 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Feb 2024to 1 Mar 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: to check the Frequency of Pulmonary Toxicity in Patients Treated for Hodgkin Lymphoma
Who may be able to join
- Patients diagnosed with Hodgkin lymphoma (HL) receiving treatment.
- Patients of all ages and both genders.
- Patients with histologically confirmed HL, as per the WHO 2016 classification.
- Patients who have undergone pulmonary function testing and assessment at specified time points during their treatment course.
- Patients with complete medical records documenting treatment regimens, including chemotherapy and radiotherapy details.
Who cannot join
- Patients with a diagnosis of another malignancy.
- Patients with incomplete medical records or missing data on treatment regimens and pulmonary function assessments.
- Patients with a history of significant pulmonary comorbidities, such as chronic obstructive pulmonary disease (COPD), interstitial lung disease, or pulmonary fibrosis, before HL diagnosis.
- Patients who are unable to complete pulmonary function tests.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanum Memorial Cancer Hospital and Research Centre, 5-B, Sector A2, Phase 5, Hayatabad
Peshawar, Khyber Pakhtunkhwa
About this study
Pulmonary toxicity during Hodgkin lymphoma treatment is significant for a variety of reasons, ranging from clinical care to therapeutic innovation and patient outcomes.
Read the detailed description
Understanding chemotherapy-induced pulmonary issues, particularly bleomycin-induced toxicity, might enhance treatment efficacy, side effects, and quality of life for Hodgkin lymphoma patients. For Hodgkin lymphoma chemotherapy patients with pulmonary difficulties, which result in significant patient morbidity and mortality, early detection, proactive surveillance, and rapid management are required. Identifying the prevalence, risk factors, and clinical signs of pulmonary toxicity helps clinicians stratify treatment.
- Conditions
- Hodgkin Lymphoma
- Being tested
- group 1
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1Diagnostic test
To determine treatment-induced pulmonary toxicity prevalence and risk factors in Hodgkin lymphoma patients during chemotherapy or radiation therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
high-resolution computed tomography
An HRCT (high-resolution computed tomography) scan is a type of CT scan healthcare providers use to get detailed images of your lungs. Providers most commonly use it to diagnose and monitor interstitial lung diseases and conditions that affect your small airways and alveoli (air sacs).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start18 Feb 2024
- Primary completion15 Jul 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Superior 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-control
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761599
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/046
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Pulmonary Toxicity in Patients Treated for Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06761599
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/046
- Conditions
- Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
Pulmonary toxicity during Hodgkin lymphoma treatment is significant for a variety of reasons, ranging from clinical care to therapeutic innovation and patient outcomes.
Detailed description
Understanding chemotherapy-induced pulmonary issues, particularly bleomycin-induced toxicity, might enhance treatment efficacy, side effects, and quality of life for Hodgkin lymphoma patients. For Hodgkin lymphoma chemotherapy patients with pulmonary difficulties, which result in significant patient morbidity and mortality, early detection, proactive surveillance, and rapid management are required. Identifying the prevalence, risk factors, and clinical signs of pulmonary toxicity helps clinicians stratify treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- to check the Frequency of Pulmonary Toxicity in Patients Treated for Hodgkin Lymphoma
Key inclusion criteria (5 listed)
- Patients diagnosed with Hodgkin lymphoma (HL) receiving treatment.
- Patients of all ages and both genders.
- Patients with histologically confirmed HL, as per the WHO 2016 classification.
- Patients who have undergone pulmonary function testing and assessment at specified time points during their treatment course.
- Patients with complete medical records documenting treatment regimens, including chemotherapy and radiotherapy details.
Key exclusion criteria (4 listed)
- Patients with a diagnosis of another malignancy.
- Patients with incomplete medical records or missing data on treatment regimens and pulmonary function assessments.
- Patients with a history of significant pulmonary comorbidities, such as chronic obstructive pulmonary disease (COPD), interstitial lung disease, or pulmonary fibrosis, before HL diagnosis.
- Patients who are unable to complete pulmonary function tests.
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 |
|---|---|---|
| group 1To determine treatment-induced pulmonary toxicity prevalence and risk factors in Hodgkin lymphoma patients during chemotherapy or radiation therapy. | Diagnostic test | – |
Primary outcome
high-resolution computed tomography
Time frame: 12 Months
An HRCT (high-resolution computed tomography) scan is a type of CT scan healthcare providers use to get detailed images of your lungs. Providers most commonly use it to diagnose and monitor interstitial lung diseases and conditions that affect your small airways and alveoli (air sacs).
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 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, run by Superior University at 1 site in Pakistan.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
high-resolution computed tomography (time frame: 12 Months). 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 7 Jan 2025.