NCT03079947

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

March 9, 2017

Last Update Submit

March 22, 2017

Conditions

Keywords

Circulating DNADiffuse Large B Cell LymphomaPeripheral T-Cell Lymphomaprognosis

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 years

Secondary Outcomes (2)

  • relapse of the disease

    within 3 years

  • progression free survival

    3 years

Study Arms (1)

Non-hodgkin Lymphoma

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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(-)
  • years old to 80 years old

You may not qualify if:

  • other tumors
  • severe infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25842160BACKGROUND
  • 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.

    PMID: 25887775BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

circulating DNA from plasma

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-Cell

Study Officials

  • Daobin Zhou, MD

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 15, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations