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

NCT ID: NCT03079947

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diffuse Large B Cell Lymphoma Peripheral T Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-hodgkin Lymphoma

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

No interventions assigned to this group

Eligibility Criteria

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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

1. other tumors
2. severe infections
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daobin Zhou, MD

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhang

Role: CONTACT

86-010-69151235

Xiao Han

Role: CONTACT

+86 18618191308

Facility Contacts

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Wei Zhang

Role: primary

+86-010-69151235

Xiao Han

Role: backup

+86 18618191308

References

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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.

Reference Type BACKGROUND
PMID: 25842160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25887775 (View on PubMed)

Other Identifiers

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PUMCH-1149

Identifier Type: -

Identifier Source: org_study_id

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