- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04263935
Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma
April 18, 2025 updated by: Yanyan Liu, Henan Cancer Hospital
Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma
Study Overview
Status
Recruiting
Conditions
Detailed Description
This trial is a prospective non-interventional observational study.
The Chinese patients with lymphoma were included and the study data on driver gene abnormalities, demographic characteristics, clinicopathological characteristics and treatment were collected to evaluate the relevance of efficacy and disease prognosis.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yanyan Liu, M.D. Ph.D
- Phone Number: +8613818176375
- Email: yyliu@zzu.edu.cn
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China
- Recruiting
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
-
Contact:
- Yanyan Liu, M.D. Ph.D
- Phone Number: +8613838176375
- Email: yyliu@zzu.edu.cn
-
Contact:
- Yanyan Liu, M.D. Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Including demographic characteristics / clinical characteristics / pathological characteristics / treatment and efficacy evaluations.
Description
Inclusion Criteria:
- Diagnosed as lymphoma (according to WHO 2017 classification criteria)
- Life expectancy no less than 3 months
- Agreeing to sign the written informed consents
Exclusion Criteria:
- Other malignant tumor history or active malignant tumor need be treated
- Researchers determine unsuited to participate in this trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of driver gene abnormalities
Time Frame: from the day of the first patient was included to the date of the end of this trial, assessed up to 36 months
|
the incidence of driver gene abnormalities by fixed gene testing technology
|
from the day of the first patient was included to the date of the end of this trial, assessed up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
objective response rate
Time Frame: from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months
|
the total proportion of patients with complete response (CR) and partial response (PR)
|
from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months
|
|
5-year overall survival
Time Frame: from the date of the first patient was included to the date of the end of this trial, assessed up to 5 years
|
from the date of first patient was included to the date of death by any cause
|
from the date of the first patient was included to the date of the end of this trial, assessed up to 5 years
|
|
Clinicopathological Characteristics
Time Frame: from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months
|
study data on clinicopathological characteristics related to incidence of driver gene abnormalities
|
from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yanyan Liu, M.D. Ph.D, Henan Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2019
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
February 3, 2020
First Submitted That Met QC Criteria
February 8, 2020
First Posted (Actual)
February 11, 2020
Study Record Updates
Last Update Posted (Actual)
April 23, 2025
Last Update Submitted That Met QC Criteria
April 18, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HNCH2019341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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