Nasopharyngeal CarcinomaNCT02481089
Polymorphisms in Key Genes of Glycolytic Pathway: Influence on Radiosensitivity in Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma and Single Nucleotide Polymorphisms, run by Hunan Province Tumor Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma, Single Nucleotide Polymorphisms, Radiosensitivity
- What is being tested?
- validation group
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: npc patients who can tolerable and agree for IMRT and concurrent chemotherapy
Who may be able to join
- pathological identified NPC
- KPS≥70
- tolerable and agree for IMRT and concurrent chemotherapy
- without severe other diseases
- informed consent
Who cannot join
- reject treatment
- cannot tolerate the treatment
- distant metastasis before treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan province tumor pospital
Changsha, Hunan, 410000
shengqi wu, M.D., 13807316075, wushengqi@hnszlyy.com
About this study
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.
- Being tested
- validation group
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validation groupOther
| Study group | Role | What they receive |
|---|---|---|
| training group | Not described Receives: Other: validation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Wang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481089
- Sponsor's protocol ID
- warburg snp
- Status last verified
- Feb 2016
- First submitted
- 2 Jun 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms in Key Genes of Glycolytic Pathway: Influence on Radiosensitivity in Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02481089
- Acronym / sponsor ID
- warburg snp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| training group | – | Other: validation group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- npc patients who can tolerable and agree for IMRT and concurrent chemotherapy
Key inclusion criteria (5 listed)
- pathological identified NPC
- KPS≥70
- tolerable and agree for IMRT and concurrent chemotherapy
- without severe other diseases
- informed consent
Key exclusion criteria (3 listed)
- reject treatment
- cannot tolerate the treatment
- distant metastasis before treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| validation group | Other | training group |
Primary outcome
progression free survival
Time frame: up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and Single Nucleotide Polymorphisms, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.