- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03079947
Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in NHL Patients
Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in Non-hodgkin Lymphoma Patients
Study Overview
Status
Detailed Description
The investigators plan to prospectively involve 300 Non-hodgkin Lymphoma patients, including both diffuse large B cell lymphomas and peripheral T cell lymphomas without previous treatment from Peking Union Medical College Hospital.
The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number and type of involved sites, prognostic index including International Prognostic Index (IPI) for DLBCLand PIT for PTCL based on medical record review.
All patients would have regular treatment and follow up in PUMCH. During the follow up, treatment response was evaluated by contrast enhanced computed tomography or PET-CT.
The peripheral blood would be collected and circulating DNA would be tested at the time of diagnosis, interim of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up, 3 year of follow-up and disease progression or relapse. TCR/BCR domain would be sequenced by high-throughput sequencing.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Xiao Han
- Phone Number: +86 18618191308
- Email: xiaoer020@vip.sina.com
Study Contact Backup
- Name: Wei Zhang
- Phone Number: 86-010-69151235
- Email: vv1223@vip.sina.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Wei Zhang
- Phone Number: +86-010-69151235
- Email: vv1223@vip.sina.com
-
Contact:
- Xiao Han
- Phone Number: +86 18618191308
- Email: xiaoer020@vip.sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- pathologically confirmed diffuse large B cell lymphoma (DLBCL nos, PCNSL, ALK+ DLBCL, DLBCL/BL) or peripheral T cell lymphoma (AITL, ALCL, PTCL nos, NK/T nasal type, EATL, HSTL)
- no treatment before
- hCG(-)
- 18 years old to 80 years old
Exclusion Criteria:
- other tumors
- severe infections
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Non-hodgkin Lymphoma
300 Non-hodgkin Lymphoma patients (age >=18y) without previous treatment would be administered, including DLBCLs and PTCLs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival
Time Frame: 3 years
|
3 years
|
relapse of the disease
Time Frame: within 3 years
|
within 3 years
|
Collaborators and Investigators
Investigators
- Study Director: Daobin Zhou, MD, Peking Union Medical College Hospital
Publications and helpful links
General Publications
- Roschewski M, Dunleavy K, Pittaluga S, Moorhead M, Pepin F, Kong K, Shovlin M, Jaffe ES, Staudt LM, Lai C, Steinberg SM, Chen CC, Zheng J, Willis TD, Faham M, Wilson WH. Circulating tumour DNA and CT monitoring in patients with untreated diffuse large B-cell lymphoma: a correlative biomarker study. Lancet Oncol. 2015 May;16(5):541-9. doi: 10.1016/S1470-2045(15)70106-3. Epub 2015 Apr 1. Erratum In: Lancet Oncol. 2015 May;16(5):e199.
- Kurtz DM, Green MR, Bratman SV, Scherer F, Liu CL, Kunder CA, Takahashi K, Glover C, Keane C, Kihira S, Visser B, Callahan J, Kong KA, Faham M, Corbelli KS, Miklos D, Advani RH, Levy R, Hicks RJ, Hertzberg M, Ohgami RS, Gandhi MK, Diehn M, Alizadeh AA. Noninvasive monitoring of diffuse large B-cell lymphoma by immunoglobulin high-throughput sequencing. Blood. 2015 Jun 11;125(24):3679-87. doi: 10.1182/blood-2015-03-635169. Epub 2015 Apr 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCH-1149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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