Nasopharyngeal CarcinomaNCT04303975
The Association of hsCRP and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma and Head and Neck Cancer, run by Jiarong Chen, MD.
Trial summary
The primary purpose of this study is to explore the association of high sensitivity C-reactive protein (hsCRP) and radiotherapy(RT)-induced toxicity in patients with nasopharyngeal carcinoma. In each patient, hsCRP levels in the pre- and post-RT plasma samples will be measured according to the schedule we set. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Head and Neck Cancer, Toxicity Due to Radiotherapy
- What is being tested?
- clinical measurements
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with nasopharyngeal carcinoma during the conducting of this trail at Jiangmen Central Hospital.
Who may be able to join
- Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors
- According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy
- Willingness to sign the informed consent and return to enrolling institution for follow-up and data collection
Who cannot join
- Patients do not conform to the inclusion criteria
- Pregnant or Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Vital organs dysfunction(for example, kidneys, heart, liver, lungs, brain)
- Other contraindications or unsuitable conditions for radiotherapy
Trial locations and contacts
No sites are listed yet.
Yanghao Ruan contact
About this study
Official title: An Explorative Study on the Association of High Sensitivity C-Reactive Protein (hsCRP) and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma
The primary purpose of this study is to explore the association of high sensitivity C-reactive protein (hsCRP) and radiotherapy(RT)-induced toxicity in patients with nasopharyngeal carcinoma. In each patient, hsCRP levels in the pre- and post-RT plasma samples will be measured according to the schedule we set.
- Being tested
- clinical measurements
- Medical subject headings
- Nasopharyngeal Carcinoma, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical measurementsOther
Only clinical parameters were recorded, no intervention was made.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients with neoadjuvant chemotherapy | The patients of group1 will receive one of the following treatments:
1. neoadjuvant chemotherapy \& concurrent chemoradiotherapy
2. neoadjuvant chemotherapy \& radiotherapy
3. neoadjuvant chemotherapy \& radiotherapy \& adjuvant chemotherapy Receives: Other: clinical measurements | |
| Group 2: Patients without neoadjuvant chemotherapy | The patients of group2 will receive one of the following treatments:
1. concurrent chemoradiotherapy
2. concurrent chemoradiotherapy \& adjuvant chemoradiotherapy
3. radiotherapy \& adjuvant chemotherapy Receives: Other: clinical measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
hsCRP levels
The hscrp levels in the plasma samples from each participant were measured at the following time points:
- at the time of diagnosis completion/before the initiation of the first neoadjuvant chemotherapy
- before the initiation of each neoadjuvant chemotherapy
- before the initiation of the first radiotherapy
- during radiotherapy, once a week
- 1 week and 4weeks after the last radiotherapy
Measured: Through treatments completion，12 weeks
Incidence of adverse events
All adverse events were recorded during treatment(for example, oral mucositis, dermatitis).
Measured: Through treatments completion，12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study startJun 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiarong Chen, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiarong Chen, MD, Jiangmen Central Hospital
- Investigators
- Jiarong Chen, PhD, Principal investigator, Affiliated Jiangmen Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303975
- Sponsor's protocol ID
- JM0019002
- Status last verified
- Jun 2020
- First submitted
- 6 Mar 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study on the Association of High Sensitivity C-Reactive Protein (hsCRP) and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04303975
- Acronym / sponsor ID
- JM0019002
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jiarong Chen, MDUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Mar 2020 (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.
The primary purpose of this study is to explore the association of high sensitivity C-reactive protein (hsCRP) and radiotherapy(RT)-induced toxicity in patients with nasopharyngeal carcinoma. In each patient, hsCRP levels in the pre- and post-RT plasma samples will be measured according to the schedule we set.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients with neoadjuvant chemotherapy | – | Other: clinical measurementsThe patients of group1 will receive one of the following treatments: 1. neoadjuvant chemotherapy \& concurrent chemoradiotherapy 2. neoadjuvant chemotherapy \& radiotherapy 3. neoadjuvant chemotherapy \& radiotherapy \& adjuvant chemotherapy |
| Group 2: Patients without neoadjuvant chemotherapy | – | Other: clinical measurementsThe patients of group2 will receive one of the following treatments: 1. concurrent chemoradiotherapy 2. concurrent chemoradiotherapy \& adjuvant chemoradiotherapy 3. radiotherapy \& adjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with nasopharyngeal carcinoma during the conducting of this trail at Jiangmen Central Hospital.
Key inclusion criteria (3 listed)
- Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors
- According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy
- Willingness to sign the informed consent and return to enrolling institution for follow-up and data collection
Key exclusion criteria (5 listed)
- Patients do not conform to the inclusion criteria
- Pregnant or Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Vital organs dysfunction(for example, kidneys, heart, liver, lungs, brain)
- Other contraindications or unsuitable conditions for radiotherapy
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 |
|---|---|---|
| clinical measurementsOnly clinical parameters were recorded, no intervention was made. | Other | Group 1: Patients with neoadjuvant chemotherapy, Group 2: Patients without neoadjuvant chemotherapy |
Primary outcome
hsCRP levels
Time frame: Through treatments completion，12 weeks
The hscrp levels in the plasma samples from each participant were measured at the following time points: 1. at the time of diagnosis completion/before the initiation of the first neoadjuvant chemotherapy 2. before the initiation of each neoadjuvant chemotherapy 3. before the initiation of the first radiotherapy 4. during radiotherapy, once a week 5. 1 week and 4weeks after the last radiotherapy
Incidence of adverse events
Time frame: Through treatments completion，12 weeks
All adverse events were recorded during treatment(for example, oral mucositis, dermatitis).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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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.
Yanghao Ruan contact
Jiarong Chen, PhD principal investigator
Affiliated Jiangmen Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and Head and Neck Cancer, run by Jiarong Chen, MD.
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 5 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jiarong Chen, PhD (86-0750-3399003, garwingchan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hsCRP levels (time frame: Through treatments completion，12 weeks). The study lists 2 primary outcomes in all. 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 11 Jun 2020.