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

Conditions

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

Study Contact Backup

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:

  1. neoadjuvant chemotherapy & concurrent chemoradiotherapy
  2. neoadjuvant chemotherapy & radiotherapy
  3. neoadjuvant chemotherapy & radiotherapy & adjuvant chemotherapy
Other: clinical measurements
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:

  1. concurrent chemoradiotherapy
  2. concurrent chemoradiotherapy & adjuvant chemoradiotherapy
  3. radiotherapy & adjuvant chemotherapy
Other: clinical measurements
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:

  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
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

Jiarong Chen, MD

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

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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