Natural Killer/T-cell LymphomaNCT07409168
Multi-modal Fusion Model and Deep Learning for Predicting Treatment Response in NKTCL
An observational study of Natural Killer/T-cell Lymphoma, run by Sun Yat-sen University.
Trial summary
This is a multicenter prospective study to develop and validate a multimodal, deep learning-based model for predicting treatment response in patients with extranodal natural killer/T-cell lymphoma (NKTCL) receiving first-line asparaginase-based therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Natural Killer/T-cell Lymphoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 31 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients with pathologically confirmed extranodal natural killer/T-cell lymphoma (NKTCL) receiving first-line asparaginase-based chemotherapy or chemoradiotherapy, with available pretreatment MRI or H\&E-stained whole-slide pathology images. Patients will be prospectively followed for treatment response and survival outcomes.
Who may be able to join
- 1. Age ≥ 18 years.
- 2. Pathologically confirmed extranodal natural killer/T-cell lymphoma (NKTCL) according to the World Health Organization (WHO) classification.
- 3. Patients who are planned to receive first-line asparaginase-based chemotherapy or chemoradiotherapy.
- 4. Patients who have either contrast-enhanced MRI of the nasopharynx obtained as part of routine clinical care or pretreatment whole-slide images (WSI) of tumor tissue from hematoxylin and eosin (H\&E)-stained sections available for analysis.
- 5. Ability to understand the study and provide written informed consent (ICF).
Who cannot join
- 1. History of other malignant tumors.
- 2. Patients with psychiatric disorders or those unable to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multi-modal Fusion Model and Deep Learning for Predicting Treatment Response in NK/T-Cell Lymphoma
This is a multicenter prospective study to develop and validate a multimodal, deep learning-based model for predicting treatment response in patients with extranodal natural killer/T-cell lymphoma (NKTCL) receiving first-line asparaginase-based therapy.
- Conditions
- Natural Killer/T-cell Lymphoma
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 |
|---|---|---|
| First-line Asparaginase-based Treatment Cohort | Participants in this cohort are patients with extranodal natural killer/T-cell lymphoma (NKTCL) who are planned to receive standard first-line asparaginase-based chemotherapy according to institutional practice. Pretreatment clinical data, contrast-enhanced magnetic resonance imaging (MRI) of the nasopharynx and neck, and digital pathology images from hematoxylin and eosin (H\&E)-stained tumor sections will be collected. Patients will be followed for progression-free survival and overall survival according to routine follow-up schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive accuracy of first-line treatment response (CR vs non-CR) according to Lugano 2014 criteria
The primary outcome is the predictive performance of the multimodal deep learning model for first-line treatment response in patients with extranodal natural killer/T-cell lymphoma (NKTCL). Treatment response is assessed according to the Lugano 2014 criteria. Model performance will be evaluated by receiver operating characteristic (ROC) analysis and quantified using the area under the curve (AUC), accuracy, sensitivity, specificity, positive predictive value, and negative predictive value by comparing model predictions with observed clinical response.
Measured: From baseline to disease response and follow-up assessments, up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Killer/T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409168
- Sponsor's protocol ID
- B2025-444
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modal Fusion Model and Deep Learning for Predicting Treatment Response in NK/T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07409168
- Acronym / sponsor ID
- B2025-444
- Conditions
- Natural Killer/T-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Feb 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.
This is a multicenter prospective study to develop and validate a multimodal, deep learning-based model for predicting treatment response in patients with extranodal natural killer/T-cell lymphoma (NKTCL) receiving first-line asparaginase-based therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-line Asparaginase-based Treatment Cohort | – | –Participants in this cohort are patients with extranodal natural killer/T-cell lymphoma (NKTCL) who are planned to receive standard first-line asparaginase-based chemotherapy according to institutional practice. Pretreatment clinical data, contrast-enhanced magnetic resonance imaging (MRI) of the nasopharynx and neck, and digital pathology images from hematoxylin and eosin (H\&E)-stained tumor sections will be collected. Patients will be followed for progression-free survival and overall survival according to routine follow-up schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients with pathologically confirmed extranodal natural killer/T-cell lymphoma (NKTCL) receiving first-line asparaginase-based chemotherapy or chemoradiotherapy, with available pretreatment MRI or H\&E-stained whole-slide pathology images. Patients will be prospectively followed for treatment response and survival outcomes.
Key inclusion criteria (5 listed)
- 1. Age ≥ 18 years.
- 2. Pathologically confirmed extranodal natural killer/T-cell lymphoma (NKTCL) according to the World Health Organization (WHO) classification.
- 3. Patients who are planned to receive first-line asparaginase-based chemotherapy or chemoradiotherapy.
- 4. Patients who have either contrast-enhanced MRI of the nasopharynx obtained as part of routine clinical care or pretreatment whole-slide images (WSI) of tumor tissue from hematoxylin and eosin (H\&E)-stained sections available for analysis.
- 5. Ability to understand the study and provide written informed consent (ICF).
Key exclusion criteria (2 listed)
- 1. History of other malignant tumors.
- 2. Patients with psychiatric disorders or those unable to provide informed consent.
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
Predictive accuracy of first-line treatment response (CR vs non-CR) according to Lugano 2014 criteria
Time frame: From baseline to disease response and follow-up assessments, up to 3 years.
The primary outcome is the predictive performance of the multimodal deep learning model for first-line treatment response in patients with extranodal natural killer/T-cell lymphoma (NKTCL). Treatment response is assessed according to the Lugano 2014 criteria. Model performance will be evaluated by receiver operating characteristic (ROC) analysis and quantified using the area under the curve (AUC), accuracy, sensitivity, specificity, positive predictive value, and negative predictive value by comparing model predictions with observed clinical response.
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 28 Apr 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Natural Killer/T-cell Lymphoma, run by Sun Yat-sen 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 5 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 28 Apr 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?
Contact Qingqing Cai, MD. PhD. (0208734282, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive accuracy of first-line treatment response (CR vs non-CR) according to Lugano 2014 criteria (time frame: From baseline to disease response and follow-up assessments, up to 3 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 28 Apr 2026.