Nasopharyngeal CancerNCT03003182
A Study of Nasopharyngeal Carcinoma From Guangdong
An observational study of Nasopharyngeal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This prospective cohort study aims to establish prognostic models, to discover toxicity associated predictors and to validate randomized trials in clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2017to May 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study includes patients with nasopharyngeal carcinoma in all stages.
Who may be able to join
- histological confirmed nasopharyngeal carcinoma;
- scanned by magnetic resonance imaging from calvaria vertex to clavicles before treatment;
- pretreatment Epstein-Barr virus deoxyribonucleic acid copy number is available;
- irradiated with intensity-modulated radiotherapy;
Who cannot join
- finishing anticancer therapy in two or more hospitals;
- pregnancy or lactation;
- diagnosed with other sort of cancer before or during the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fang-Yun Xie, M.D., +86-020-87342618, xiefy@sysucc.org.cn
Pu-Yun OuYang, M.D., +86-020-87342618, ouyangpy@sysucc.org.cn
About this study
Official title: A Prospective Cohort Study of Nasopharyngeal Carcinoma to Establish Prognostic Models, to Discover Toxicity Associated Predictors and to Validate Randomized Trials in Clinical Practice
This prospective cohort study aims to establish prognostic models, to discover toxicity associated predictors and to validate randomized trials in clinical practice.
- Conditions
- Nasopharyngeal Cancer
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| in clinical trials | Not described | |
| out of clinical trials | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3-years
Secondary outcomes (1)
Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start10 May 2017
- Primary completionMay 2019 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang-Yun Xie, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003182
- Sponsor's protocol ID
- 2016-FXY-098-Dept. of RT
- Status last verified
- Jun 2017
- First submitted
- 18 Dec 2016
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yang SS, Wu YS, Pang YJ, Xiao SM, Zhang BY, Liu ZQ, Chen EN, Zhang X, OuYang PY, Xie FY. Development and validation of radiologic scores for guiding individualized induction chemotherapy in T3N1M0 nasopharyngeal carcinoma. Eur Radiol. 2022 Jun;32(6):3649-3660. doi: 10.1007/s00330-021-08460-1. Epub 2022 Jan 6.
PubMed 34989842
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Nasopharyngeal Carcinoma to Establish Prognostic Models, to Discover Toxicity Associated Predictors and to Validate Randomized Trials in Clinical Practice
- ClinicalTrials.gov ID
- NCT03003182
- Acronym / sponsor ID
- 2016-FXY-098-Dept. of RT
- Conditions
- Nasopharyngeal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 26 Dec 2016 (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.
This prospective cohort study aims to establish prognostic models, to discover toxicity associated predictors and to validate randomized trials in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in clinical trials | – | – |
| out of clinical trials | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes patients with nasopharyngeal carcinoma in all stages.
Key inclusion criteria (4 listed)
- histological confirmed nasopharyngeal carcinoma;
- scanned by magnetic resonance imaging from calvaria vertex to clavicles before treatment;
- pretreatment Epstein-Barr virus deoxyribonucleic acid copy number is available;
- irradiated with intensity-modulated radiotherapy;
Key exclusion criteria (3 listed)
- finishing anticancer therapy in two or more hospitals;
- pregnancy or lactation;
- diagnosed with other sort of cancer before or during the treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: 3-years
1 secondary outcome
Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0
Time frame: 30-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Derived from this study: PubMed 34989842Yang SS, Wu YS, Pang YJ, Xiao SM, Zhang BY, Liu ZQ, Chen EN, Zhang X, OuYang PY, Xie FY. Development and validation of radiologic scores for guiding individualized induction chemotherapy in T3N1M0 nasopharyngeal carcinoma. Eur Radiol. 2022 Jun;32(6):3649-3660. doi: 10.1007/s00330-021-08460-1. Epub 2022 Jan 6.
- Individual participant dataSharing planned: No
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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 Cancer, run by Sun Yat-sen University 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 4 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 15 Jun 2017. 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?
Contact Fang-Yun Xie, MD (+86-02087342618, xiefy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003182, which also lists 1 linked publication.
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 15 Jun 2017.