Multi-modal Fusion Model and Deep Learning for Predicting Treatment Response in NKTCL

NCT07409168 | Not Yet Recruiting

• 1 other identifier: B2025-444
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Natural Killer/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to disease response and follow-up assessments, up to 3 years.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. Age ≥ 18 years.
• \. Pathologically confirmed extranodal natural killer/T-cell lymphoma (NKTCL) according to the World Health Organization (WHO) classification.
• \. Patients who are planned to receive first-line asparaginase-based chemotherapy or chemoradiotherapy.
• \. 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.
• \. Ability to understand the study and provide written informed consent (ICF).

You may not qualify if:

• \. History of other malignant tumors.
• \. Patients with psychiatric disorders or those unable to provide informed consent.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

0208734282; caiqq@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief phycisian

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04