Nasopharyngeal CarcinomaNCT05912582
Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Intensity modulated radiation therapy (IMRT) combined with chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 25 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly histologically confirmed stage IVa nasopharyngeal carcinoma
Who may be able to join
- Patients with newly histologically confirmed nasopharyngeal carcinoma
- No evidence of distant metastasis (M0)
- Written informed consent
Who cannot join
- Treatment with palliative intent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma.
Read the detailed description
Primary endpoint: Evaluation of the major pathological response of nasopharyngeal carcinoma patients.
Secondary endpoint: Evaluation of failure-free survival and overall survival of nasopharyngeal carcinoma patients.
Outline: This is a prospective observational study. Patients of nasopharyngeal carcinoma undergo inductive chemotherapy and concurrent chemoradiotherapy. Whole blood is obtained from patients when recruited, completing 10, 20, 32 fractions of radiation therapy, 3 months after radiation therapy and disease progression. Tumor tissue specimens are obtained from patients when recruited and disease progression. The samples are analyzed for biomarkers and spatial transcriptomics. The biomarkers and spatial transcriptomics are correlated with clinical outcomes (major pathological response, progression-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).
The analysis aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help in precision medicine of nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Intensity modulated radiation therapy (IMRT) combined with chemotherapy
- Keywords
- Nasopharyngeal Carcinoma, Biomarker, Spatial Transcriptomics
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity modulated radiation therapy (IMRT) combined with chemotherapyRadiation
Also called IMRT
Intensity modulated radiation therapy (IMRT) combined with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Observation Group | Not described Receives: Radiation: Intensity modulated radiation therapy (IMRT) combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
major pathological response
Measured: 3 months after radiation therapy
Secondary outcomes (2)
Progression-free Survival
Measured: 2 years after radiation therapy
Overall Survival
Measured: 2 years after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start25 Dec 2025 (estimated)
- Primary completion25 Jun 2027 (estimated)
- Study completion25 Dec 2028 (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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lirong Wu, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912582
- Sponsor's protocol ID
- Biomarkers- NPC
- Status last verified
- Dec 2025
- First submitted
- 12 Jun 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05912582
- Acronym / sponsor ID
- Biomarkers- NPC
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Biomarker, Spatial Transcriptomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 25 Dec 2028 (estimated)
- First posted
- 22 Jun 2023 (actual)
- 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 clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma.
Detailed description
Primary endpoint: Evaluation of the major pathological response of nasopharyngeal carcinoma patients.
Secondary endpoint: Evaluation of failure-free survival and overall survival of nasopharyngeal carcinoma patients.
Outline: This is a prospective observational study. Patients of nasopharyngeal carcinoma undergo inductive chemotherapy and concurrent chemoradiotherapy. Whole blood is obtained from patients when recruited, completing 10, 20, 32 fractions of radiation therapy, 3 months after radiation therapy and disease progression. Tumor tissue specimens are obtained from patients when recruited and disease progression. The samples are analyzed for biomarkers and spatial transcriptomics. The biomarkers and spatial transcriptomics are correlated with clinical outcomes (major pathological response, progression-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).
The analysis aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help in precision medicine of nasopharyngeal carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation Group | – | Radiation: Intensity modulated radiation therapy (IMRT) combined with chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly histologically confirmed stage IVa nasopharyngeal carcinoma
Key inclusion criteria (3 listed)
- Patients with newly histologically confirmed nasopharyngeal carcinoma
- No evidence of distant metastasis (M0)
- Written informed consent
Key exclusion criteria (1 listed)
- Treatment with palliative intent
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 |
|---|---|---|
| Intensity modulated radiation therapy (IMRT) combined with chemotherapyAlso: IMRTIntensity modulated radiation therapy (IMRT) combined with chemotherapy | Radiation | Observation Group |
Primary outcome
major pathological response
Time frame: 3 months after radiation therapy
2 secondary outcomes
Progression-free Survival
Time frame: 2 years after radiation therapy
Overall Survival
Time frame: 2 years after radiation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
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, run by Jiangsu Cancer Institute & 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lirong Wu (+86-13701588737, wulirong126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major pathological response (time frame: 3 months after radiation therapy). 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 26 Dec 2025.