T-NK Cell LymphomaNCT06747299
The Value of Artificial Intelligence-based 18F-FDG PET/CT in Diferential Diagnosis, Efficacy Prediction and Prognosis Prediction of T-NK Cell Lymphoma: a Clinical Study
An observational study of T-NK Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
Based on the PET/CT imaging data of patients with T-NK cell lymphoma, machine learning and deep learning methods are used to extract imaging features, establish a T-NK cell lymphoma prediction model, and provide more scientific and accurate prognosis prediction for the clinic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T-NK Cell Lymphoma
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pathological histology confirmed as T-NK Cell Lymphoma at Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Who may be able to join
- 1. Pathological histology confirmed as T-NK Cell Lymphoma; 2.18F-FDG PET/CT examination before treatment; 3. Using modern best practice treatment options; 4. Complete clinicopathological and follow-up data were obtained.
Who cannot join
- The patient had previously received antitumor therapy;
- The patient had a history of other tumors;
- Incomplete clinical information or imaging data;
- Concomitant other malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality
About this study
Based on the PET/CT imaging data of patients with T-NK cell lymphoma, machine learning and deep learning methods are used to extract imaging features, establish a T-NK cell lymphoma prediction model, and provide more scientific and accurate prognosis prediction for the clinic.
Read the detailed description
This study adopts a multicenter retrospective cohort study design，we provided PET/CT of 200 patients with T-NK cell lymphoma as an external validation set for model validation.
- Conditions
- T-NK Cell Lymphoma
- Keywords
- T-NK cell Lymphoma, PET/CT, Diferential Diagnosis, Efficacy Prediction, Prognosis Prediction
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
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 |
|---|---|---|
| patients diagnosis of T-NK cell lymphoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the value of Artificial Intelligence-based 18F-FDG PET/CT of T-NK Cell Lymphoma
The Value of Artificial Intelligence-based 18F-FDG PET/CT in Diferential Diagnosis, Efficacy Prediction and Prognosis Prediction of T-NK Cell Lymphoma
Measured: Within 1 week of enrollment and after 3 months treatment
Secondary outcomes (2)
Progress free survival
Progress free survival
Measured: 3 years
Overall survival
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2025 (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 T-NK Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Principal investigator, GUO RUI, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747299
- Sponsor's protocol ID
- RuijinH 2024-349
- Status last verified
- Sep 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Artificial Intelligence-based 18F-FDG PET/CT in Diferential Diagnosis, Efficacy Prediction and Prognosis Prediction of T-NK Cell Lymphoma: a Clinical Study
- ClinicalTrials.gov ID
- NCT06747299
- Acronym / sponsor ID
- RuijinH 2024-349
- Conditions
- T-NK Cell Lymphoma
- Keywords
- T-NK cell Lymphoma, PET/CT, Diferential Diagnosis, Efficacy Prediction, Prognosis Prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Dec 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.
Based on the PET/CT imaging data of patients with T-NK cell lymphoma, machine learning and deep learning methods are used to extract imaging features, establish a T-NK cell lymphoma prediction model, and provide more scientific and accurate prognosis prediction for the clinic.
Detailed description
This study adopts a multicenter retrospective cohort study design，we provided PET/CT of 200 patients with T-NK cell lymphoma as an external validation set for model validation.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosis of T-NK cell lymphoma | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathological histology confirmed as T-NK Cell Lymphoma at Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Key inclusion criteria (1 listed)
- 1. Pathological histology confirmed as T-NK Cell Lymphoma; 2.18F-FDG PET/CT examination before treatment; 3. Using modern best practice treatment options; 4. Complete clinicopathological and follow-up data were obtained.
Key exclusion criteria (4 listed)
- The patient had previously received antitumor therapy;
- The patient had a history of other tumors;
- Incomplete clinical information or imaging data;
- Concomitant other malignant tumors.
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
Evaluation the value of Artificial Intelligence-based 18F-FDG PET/CT of T-NK Cell Lymphoma
Time frame: Within 1 week of enrollment and after 3 months treatment
The Value of Artificial Intelligence-based 18F-FDG PET/CT in Diferential Diagnosis, Efficacy Prediction and Prognosis Prediction of T-NK Cell Lymphoma
2 secondary outcomes
Progress free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
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 24 Dec 2024.
- Individual participant dataSharing planned: No
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Lymphoma
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.
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 T-NK Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
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 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: opening soon, as of the sponsor's last update on 24 Dec 2024. 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 China. 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?
Contact Guo rui Deputy director (13361860108, gr11734@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the value of Artificial Intelligence-based 18F-FDG PET/CT of T-NK Cell Lymphoma (time frame: Within 1 week of enrollment and after 3 months treatment). 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 24 Dec 2024.