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

NCT ID: NCT04509804

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-10
• Study Completion Date: 2020-01-01

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

non-interventional

non-interventional

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mei Dong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mei Dong

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

GeneNKT

Identifier Type: -

Identifier Source: org_study_id