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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04303975
Other study ID # JM0019002
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2021
Est. completion date December 2021

Study information

Verified date June 2020
Source Jiangmen Central Hospital
Contact Jiarong Chen, PhD
Phone 86-0750-3399003
Email garwingchan@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
clinical measurements
Only clinical parameters were recorded, no intervention was made.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jiarong Chen, MD

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Through treatments completion,12 weeks
Primary Incidence of adverse events All adverse events were recorded during treatment(for example, oral mucositis, dermatitis). Through treatments completion,12 weeks
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