Diffuse Large B Cell Lymphoma, Gene MutationNCT04825899
Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma
An observational study of Diffuse Large B Cell Lymphoma, Gene Mutation, run by Fudan University at 1 site in China.
Trial summary
to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing and analyze the relationship between this gene abnormalities and the efficacy and prognosis in diffuse large B cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Gene Mutation
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2021to 8 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: all new diagnosed DLBCL
Who may be able to join
- ECOG PS 0-2;
- histological diagnosed diffuse large B cell lymphoma;
- normal hematological, hepatal, renal function;
- normal heart function with LVEF ≥ 50%;
Who cannot join
- Diagnosed as a malignant tumor other than lymphoma or receiving treatment, except for the following conditions:
- ①Have received treatment for the purpose of curing, and no malignant tumor with known active disease occurred ≥5 years before enrollment;
- ②Skin basal cell carcinoma (except melanoma) that has received adequate treatment and has no signs of disease;
- ③ Carcinoma in situ of the cervix that has received adequate treatment and has no signs of disease.
- Heart disease with clinical significance, including unstable angina pectoris, acute myocardial infarction within 6 months before screening.
- Congestive heart failure (NYHA) heart function is graded in grade III or IV (Annex 3)
Show all 12Show fewer
- Severe arrhythmia requiring treatment.
- Patients with active hepatitis B and HIV infection.
- Women who are pregnant or breastfeeding
- Patients who have received organ transplants in the past
- Patients with severe active infection
- Have a history of severe neurological or psychiatric diseases, including dementia or epilepsy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Qunling Zhang, PhD, +86-021-64175590 ext. 88900, zqldoc@163.com
About this study
Official title: A Non-interventional Study on the Relationship Between Gene Abnormalities and the Efficacy and Prognosis in Patients With Diffuse Large B-cell Lymphoma
to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing and analyze the relationship between this gene abnormalities and the efficacy and prognosis in diffuse large B cell lymphoma.
Read the detailed description
This is one arm, single center non-intervention study. New diagnosed diffuse large B cell lymphoma patients were enrolled to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing, then patients received standard treatment with R-CHOP, R2CHOP and DA-EPOCH by investigate's choice according to the patients pathological characteristics. the basic characteristics and treatment response and progression-free survival and overall survival were collected and analyzed with the gene abnormalities. a total of 100 diffuse large B cell lymphoma patients will enrolled in one year and will finish after 3 years.
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| NGS Panel | patients who had NGS 481 gene mutation detected |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of gene mutation in DLBCL
Measured: 3 years
The incidence of gene mutation in different subtype of DLBCL
Measured: 3years
The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities
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 posted1 Apr 2021
- Study start8 Mar 2021
- Primary completion8 Feb 2022 (estimated)
- Study completion8 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma, Gene MutationStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junning Cao, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825899
- Sponsor's protocol ID
- gene abnormalities in DLBCL
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study on the Relationship Between Gene Abnormalities and the Efficacy and Prognosis in Patients With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04825899
- Acronym / sponsor ID
- gene abnormalities in DLBCL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 8 Feb 2022 (estimated)
- Study completion
- 8 Feb 2024 (estimated)
- First posted
- 1 Apr 2021 (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.
to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing and analyze the relationship between this gene abnormalities and the efficacy and prognosis in diffuse large B cell lymphoma.
Detailed description
This is one arm, single center non-intervention study. New diagnosed diffuse large B cell lymphoma patients were enrolled to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing, then patients received standard treatment with R-CHOP, R2CHOP and DA-EPOCH by investigate's choice according to the patients pathological characteristics. the basic characteristics and treatment response and progression-free survival and overall survival were collected and analyzed with the gene abnormalities. a total of 100 diffuse large B cell lymphoma patients will enrolled in one year and will finish after 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGS Panel | – | –patients who had NGS 481 gene mutation detected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all new diagnosed DLBCL
Key inclusion criteria (4 listed)
- ECOG PS 0-2;
- histological diagnosed diffuse large B cell lymphoma;
- normal hematological, hepatal, renal function;
- normal heart function with LVEF ≥ 50%;
Key exclusion criteria (12 listed)
- Diagnosed as a malignant tumor other than lymphoma or receiving treatment, except for the following conditions:
- ①Have received treatment for the purpose of curing, and no malignant tumor with known active disease occurred ≥5 years before enrollment;
- ②Skin basal cell carcinoma (except melanoma) that has received adequate treatment and has no signs of disease;
- ③ Carcinoma in situ of the cervix that has received adequate treatment and has no signs of disease.
- Heart disease with clinical significance, including unstable angina pectoris, acute myocardial infarction within 6 months before screening.
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 |
|---|---|---|
| Other | NGS Panel |
Primary outcome
the incidence of gene mutation in DLBCL
Time frame: 3 years
The incidence of gene mutation in different subtype of DLBCL
Time frame: 3years
The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Diffuse Large B Cell Lymphoma, Gene Mutation, run by Fudan 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qunling Zhang, PhD (+86-021-64175590 ext. 88900, zqldoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of gene mutation in DLBCL (time frame: 3 years). The study lists 3 primary outcomes in all. 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 1 Apr 2021.