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Completed

NCT Number: NCT04509804

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

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.

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Key information

Conditions

Lymphoid Neoplasm

Sex eligibility

All sexes

Study type

Observational

Primary location

Mei Dong

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Non-Interventional

Other

non-interventional

Primary outcomes

  1. Concordance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Target Gene Sequencing for Advanced Stage, Relapsed/Refractory Natural Killer/T-cell Lymphoma and the Correlation Between Gene Abmormalities and Chemotherapy Efficacy

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 12, 2020
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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