Extranodal Natural Killer/T-cell LymphomaNCT05343377
A Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
A study testing circulate free methylated EBV DNA in people with Extranodal Natural Killer/T-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a prospective, multicenter, open-label, single-arm clinical study. This study plans to enroll 72 newly diagnosed ENKTCL patients. The enrollment was completed in 2 years, and the follow-up was terminated in 4 years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extranodal Natural Killer/T-cell Lymphoma
- What is being tested?
- circulate free methylated EBV DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2028
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed ENKTCL confirmed by pathological tissue, the diagnostic criteria refer to the 2016 WHO diagnostic criteria
- Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol
Who cannot join
- The investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
jinhua liang contact
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing
wei xu, 025-68306034, xuwei10000@hotmail.com
About this study
Official title: Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
This study is a prospective, multicenter, open-label, single-arm clinical study. This study plans to enroll 72 newly diagnosed ENKTCL patients. The enrollment was completed in 2 years, and the follow-up was terminated in 4 years. To observe the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS rate, 2-year OS rate, and CR rate in newly diagnosed ENKTCL patients; and to clarify the prognostic stratification ability of PINK-cpgE compared with PINK-E
- Being tested
- circulate free methylated EBV DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circulate free methylated EBV DNADiagnostic test
Accuracy of circulating free methylated EBV DNA in predicting 2-year PFS
| Study group | Role | What they receive |
|---|---|---|
| circulate free methylated EBV DNA predicts PFS rate in ENKTCL | Experimental | Not described Receives: Diagnostic Test: circulate free methylated EBV DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL
Measured: 2 years
Secondary outcomes (1)
To assess the accuracy of circulating free methylated EBV DNA in predicting 2-year OS and CR rates in newly diagnosed ENKTCL patients
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 posted25 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal Natural Killer/T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhenjiang First People's Hospital, Changzhou First People's Hospital, Changzhou Second People's Hospital, Wuxi People's Hospital, Second Affiliated Hospital of Soochow University, Affiliated Hospital of Nantong University, Huai'an First People's Hospital, Yancheng First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343377
- Sponsor's protocol ID
- IRB-GL1-AF02
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05343377
- Acronym / sponsor ID
- IRB-GL1-AF02
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Zhenjiang First People's Hospital, Changzhou First People's Hospital, Changzhou Second People's Hospital, Wuxi People's Hospital, Second Affiliated Hospital of Soochow University, Affiliated Hospital of Nantong University, Huai'an First People's Hospital, Yancheng First People's Hospital
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 25 Apr 2022 (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 study is a prospective, multicenter, open-label, single-arm clinical study. This study plans to enroll 72 newly diagnosed ENKTCL patients. The enrollment was completed in 2 years, and the follow-up was terminated in 4 years. To observe the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS rate, 2-year OS rate, and CR rate in newly diagnosed ENKTCL patients; and to clarify the prognostic stratification ability of PINK-cpgE compared with PINK-E
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| circulate free methylated EBV DNA predicts PFS rate in ENKTCL | Experimental | Diagnostic Test: circulate free methylated EBV DNA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- newly diagnosed ENKTCL confirmed by pathological tissue, the diagnostic criteria refer to the 2016 WHO diagnostic criteria
- Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol
Key exclusion criteria (1 listed)
- The investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study
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 |
|---|---|---|
| circulate free methylated EBV DNAAccuracy of circulating free methylated EBV DNA in predicting 2-year PFS | Diagnostic test | circulate free methylated EBV DNA predicts PFS rate in ENKTCL |
Primary outcome
Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL
Time frame: 2 years
1 secondary outcome
To assess the accuracy of circulating free methylated EBV DNA in predicting 2-year OS and CR rates in newly diagnosed ENKTCL patients
Time frame: 2 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 25 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
jinhua liang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing circulate free methylated EBV DNA in people with Extranodal Natural Killer/T-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 2 inclusion and 1 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 25 Apr 2022. 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 wei xu (025-68306034, xuwei10000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL (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 25 Apr 2022.