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Status unknownNCT03079947Updated Mar 27, 2017

Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in NHL Patients

An observational study in Diffuse Large B Cell Lymphoma and Peripheral T Cell Lymphoma, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
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Study summary

The purpose of this study is to evaluate the effectiveness of circulating DNA from peripheral blood for predicting the prognosis and relapse in DLBCL and PTCL patients.

Read the 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.

02

Conditions studied

  • Diffuse Large B Cell Lymphoma
  • Peripheral T Cell Lymphoma

Keywords

  • Circulating DNA
  • Diffuse Large B Cell Lymphoma
  • Peripheral T-Cell Lymphoma
  • prognosis
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 300 is above the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients diagnosed to be diffuse large B cell lymphoma or peripheral T cell lymphoma without any previous treatment in Peking Union Medical College Hospital (PUMCH) would be included.

Inclusion criteria

  1. 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)
  2. no treatment before
  3. hCG(-)
  4. 18 years old to 80 years old

Exclusion criteria

Exclusion Criteria:

  1. other tumors
  2. severe infections
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Non-hodgkin Lymphoma

    300 Non-hodgkin Lymphoma patients (age \>=18y) without previous treatment would be administered, including DLBCLs and PTCLs.

06

What researchers measure

Primary outcomes

  1. overall survival

    Time frame: 3 years

Secondary outcomes

  1. relapse of the disease

    Time frame: within 3 years

  2. progression free survival

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
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References and documents

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. doi: 10.1016/S1470-2045(15)70217-2. PubMed 25842160 ↗
  • 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. PubMed 25887775 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03079947
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Mar 15, 2017
Start date
Jan 2017
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
Mar 27, 2017

Study contacts

Wei Zhang
Contact
vv1223@vip.sina.com
86-010-69151235
Xiao Han
Contact
xiaoer020@vip.sina.com
+86 18618191308
Daobin Zhou, MD
study director · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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