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

NCT04509804 | Completed DMC

• 1 other identifier: GeneNKT
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Concordance

  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

  2 years

Interventions

non-interventional OTHER

non-interventional

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to recurit 30 eligile patients who are diagnosed in our hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Mei Dong

Beijing, Beijing Municipality, 100021, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 12, 2020
• Study Start: May 10, 2018
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

CN (1)