Nasopharyngeal CarcinomaNCT05126160
Immune Score Based Radiomics in Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 5 sites in China.
Trial summary
In nasopharyngeal carcinoma (NPC), tumor, node and metastasis (TNM) staging system is the main tool for determining treatment strategy and assessment of prognosis. However, the prognoses of patients with the same TNM stage after similar treatment vary widely. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Immune Score Based Radiomics
- How many people
- 494 participants
- Where
- 5 sitesChina
- Study dates
- 5 Nov 2021to Dec 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-metastatic NPC patients receive radical radiotherapy with/without induction or concurrent chemotherapy. De novo metastatic NPC patients would receive at least 4 cycles of platinum-based therapy.
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing/keratinizing carcinoma.
- ECOG Performance status: 0-1 With normal liver function test (ALT, AST ≤2.5ULN) Renal: creatinine clearance ≥60ml/min Without hematopathy,marrow: WBC >4109/L, HGB>90G/L, and PLT>100109/L. Written informed consent
Who cannot join
- Contraindications for MRI scan Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), or emotional disturbance.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaozhong Chen, 571-88128202 ext. +86, cxzfyun@sina.com
Caineng Cao
- Recruiting
Ningbo First Hospital
Ningbo, Ningbo, 315000
Pengrong Lou
Pengrong Lou
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Ningbo, 315000
Miaozhen Lu, lmz2005@yeah.net
Miaozhen Lu
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Wenzhou, 325000
Changlin Zou, zcl19670115@163.com
Changlin Zou
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Xiangpan Li, rm001227@whu.edu.cn
Xiangpan Li
About this study
Official title: Immune Score Based Radiomics in Nasopharyngeal Carcinoma (IMRAN Study)
In nasopharyngeal carcinoma (NPC), tumor, node and metastasis (TNM) staging system is the main tool for determining treatment strategy and assessment of prognosis. However, the prognoses of patients with the same TNM stage after similar treatment vary widely. The aim of this study is to establish an immune score based radiomic staging system for NPC.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Immune Score Based Radiomics
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Score Based RadiomicsDiagnostic test
To establish an immune score based radiomic staging system for nasopharyngeal carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
The AUC of the immune score based radiomic staging system
Measured: Median follow-up time of 5 years for the whole group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start5 Nov 2021
- Primary completionOct 2022 (estimated)
- Study completionDec 2027 (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.
- More trials run by Zhejiang Cancer HospitalThe 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
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Ningbo No. 1 Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaozhong Chen, Principal investigator, Department of Radiation Oncology, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126160
- Sponsor's protocol ID
- ZJCH-2021-NPC01
- Status last verified
- Nov 2021
- First submitted
- 7 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Score Based Radiomics in Nasopharyngeal Carcinoma (IMRAN Study)
- ClinicalTrials.gov ID
- NCT05126160
- Acronym / sponsor ID
- ZJCH-2021-NPC01
- Conditions
- Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Ningbo No. 1 Hospital
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Nov 2021 (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.
In nasopharyngeal carcinoma (NPC), tumor, node and metastasis (TNM) staging system is the main tool for determining treatment strategy and assessment of prognosis. However, the prognoses of patients with the same TNM stage after similar treatment vary widely. The aim of this study is to establish an immune score based radiomic staging system for NPC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-metastatic NPC patients receive radical radiotherapy with/without induction or concurrent chemotherapy. De novo metastatic NPC patients would receive at least 4 cycles of platinum-based therapy.
Key inclusion criteria (2 listed)
- Patients with newly histologically confirmed non-keratinizing/keratinizing carcinoma.
- ECOG Performance status: 0-1 With normal liver function test (ALT, AST ≤2.5ULN) Renal: creatinine clearance ≥60ml/min Without hematopathy,marrow: WBC >4109/L, HGB>90G/L, and PLT>100109/L. Written informed consent
Key exclusion criteria (1 listed)
- Contraindications for MRI scan Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), or emotional disturbance.
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 |
|---|---|---|
| Immune Score Based RadiomicsTo establish an immune score based radiomic staging system for nasopharyngeal carcinoma | Diagnostic test | – |
Primary outcome
Area Under Curve (AUC)
Time frame: Median follow-up time of 5 years for the whole group
The AUC of the immune score based radiomic staging system
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 18 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Xiaozhong Chen principal investigator
Department of Radiation Oncology, Zhejiang Cancer Hospital
5 sites 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 Zhejiang Cancer Hospital at 5 sites 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 2 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: looking for participants now, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Xiaozhong Chen (0571-88128202 ext. +86, cxzfyun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under Curve (AUC) (time frame: Median follow-up time of 5 years for the whole group). 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 18 Nov 2021.