The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study

Not yet recruiting

• Conditions: NPC Patients

• Registration Number: NCT03637634
• Lead Sponsor: Hai-Qiang Mai,MD,PhD

Brief Summary

The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study will investigate the long-term effects of nasopharyngeal carcinoma (NPC) and its associated therapies. A prospective and retrospective cohort study will be conducted through a multi-institutional collaboration. This project will study children and adolescents exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.

Detailed Description

The study will focus on the following objectives:

* Characterize survivors' health with respect to disease- and treatment-related factors.

* Investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (e.g., cardiovascular, reproductive, second cancers, etc...).

* Compare the mortality experience of survivors with the general population.

* Characterize the health-related behaviors, patterns of medical care, and medical follow-up needs of survivors.

* Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes.

* Collect and store biologic samples (saliva, blood, second tumor tissue) to correlate with health outcomes and use for future research.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Last Update Submitted: 2018-08-26
• Last Update Posted: 2018-08-28
• Study Start: 2018-09-01
• Primary Completion: 2030-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients or their siblings must be informed of the investigational nature of this study and give written informed consent.

  • Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II or III) before age 21 years at one of participating centers.

Exclusion Criteria

• Already involved in other blind clinical trial.
• The information of tumour response evaluation and survival data cannot be obtained.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival(OS)	5 years	The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

Secondary Outcome Measures

Name	Time	Method
Progress-free survival(PFS)	5 years	Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up
Locoregional failure-free survival(LRFS)	5 years	The LRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)	3 months	The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Distant metastasis-free survival(DMFS)	5 years	The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit