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NCT02481089 Clinical Trial

Polymorphisms in Key Genes of Glycolytic Pathway: Influence on Radiosensitivity in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02481089
Other study ID # warburg snp
Secondary ID
Status Recruiting
Phase N/A
First received June 2, 2015
Last updated February 17, 2016
Start date June 2015

Study information
Verified date February 2016
Source Hunan Province Tumor Hospital
Contact n/a
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Observational

Clinical Trial Summary

Warburg effect is an important feature of tumors,and genetic variation is one of the main factors of individual differences to radiotherapy treatment response for nasopharyngeal carcinoma(NPC). Through the previous work investigators found that the p53 codon72 (Pro/Arg) was related to the prognosis of NPC; Using the method of proteomics, investigators discovered glycolysis related gene such as PGK1, ALDOA，was associated with radiosensitivity.Thus,with all the previous work,investigators hypothesize that the key gene polymorphisms in glycolytic pathway, such as p53 , influence the glycolytic pathway,which leads to differences in radiosensitivity of NPC. This projects will include 600 cases of patients with NPC to detect common glycolytic key genes polymorphisms. Besides,investigators correlate these factors with their radiosensitivity and prognosis.Then, prediction model will be established, and validation of the prediction model will be done. Using enzyme-labeling instrument ，comet assay and clonogenic assay，cytological experiments will further investigate the influence of key gene polymorphisms on the glycolysis efficiency and mechanism of radiation sensitivity.Thus,investigators could provide theoretical basis of individualized treatment for NPC.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- pathological identified NPC

- KPS=70

- tolerable and agree for IMRT and concurrent chemotherapy

- without severe other diseases

- informed consent

Exclusion Criteria:

- reject treatment

- cannot tolerate the treatment

- distant metastasis before treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• validation group

Locations
Country Name City State
China Hunan province tumor pospital Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression free survival up to 60 months No
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