Target Gene Sequencing for Advanced Stage, Relapsed or Refractory Natural Killer/T-cell Lymphoma

Completed

• Conditions: Lymphoid Neoplasm

• Registration Number: NCT04509804
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

Although modern radiation techniques combined with chemotherapy has greatly improved the local control and long-term survivals for patients with early-stage NKTCL, relapse and systemic dissemination are common for localized patients. Relapsed/refractory diseases together with advanced stage NKTCLs uaually progress rapidly with poor prognosis (5-year overall survival rate, 0-20%). According to published studies, some recurrent genetic alternations have been identified in NKTCL, including oncogene/tumor suppressive gene abberants, epigenetic changes, cellular signaling pathways abnormalities, cellular apoptosis related genes and so forth. However, the gene profiling techniques and materials vary in different studies, no consensus has been reached on the gene abnormalities of advanced, or relapsed/refractory NKTCL up to now. Additionally, gene sequencing using ctDNA of peripheral blood has been unexploited in NKTCL patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-10
• Study First Submitted: 2018-08-07
• Primary Completion: 2019-09-01
• Study Completion: 2020-01-01
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-10
• Last Update Submitted: 2020-08-10
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
2. stage III/IV disease; or relapsed or refractory disease after at least one line prior teratment;
3. age ≥ 18 years;
4. ECOG performance status 0-2;
5. at least one measurable lesion;
6. adequate hematological, hepatic, and renal functions;
7. life expectancy of more than 3 months.

Exclusion Criteria

1. Previously untreated stage I/II disease;
2. with no adequate tumour tissue;
3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance	2 years	The concordance of plasma cfDNA genotyping and tumor genotyping is defined as the ratio of gene variants detected in tumor and cfDNA to variants identified in tumor

Trial Locations

Locations (1)

Mei Dong; 🇨🇳 Beijing, Beijing, China