- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04303975
The Association of hsCRP and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma
June 9, 2020 updated by: Jiarong Chen, MD
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiarong Chen, PhD
- Phone Number: 86-0750-3399003
- Email: garwingchan@163.com
Study Contact Backup
- Name: Yanghao Ruan
- Email: ruanyanghao@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with nasopharyngeal carcinoma during the conducting of this trail at Jiangmen Central Hospital.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1: Patients with neoadjuvant chemotherapy
The patients of group1 will receive one of the following treatments:
|
Only clinical parameters were recorded, no intervention was made.
|
Group 2: Patients without neoadjuvant chemotherapy
The patients of group2 will receive one of the following treatments:
|
Only clinical parameters were recorded, no intervention was made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
Through treatments completion,12 weeks
|
Incidence of adverse events
Time Frame: Through treatments completion,12 weeks
|
All adverse events were recorded during treatment(for example, oral mucositis, dermatitis).
|
Through treatments completion,12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jiarong Chen, PhD, Affiliated Jiangmen Hospital of Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
March 6, 2020
First Submitted That Met QC Criteria
March 7, 2020
First Posted (Actual)
March 11, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 9, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- JM0019002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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