NCT02481089

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

June 2, 2015

Last Update Submit

February 17, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    up to 60 months

Study Arms (1)

training group

Other: validation group

Interventions

training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

npc patients who can tolerable and agree for IMRT and concurrent chemotherapy

You may qualify if:

  • pathological identified NPC
  • KPS≥70
  • tolerable and agree for IMRT and concurrent chemotherapy
  • without severe other diseases
  • informed consent

You may not qualify if:

  • reject treatment
  • cannot tolerate the treatment
  • distant metastasis before treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan province tumor pospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of thoracic radiation oncology department

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 25, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations