The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study

Conditions
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NPC Patients

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NPC survivors<br>Survivors of NPC, diagnosed under 21 years of age, between 1990 and 2030. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, for an increased risk of late-occurring events associated with excess mortality and morbidity. | |
| Sibling Controls<br>A group of sibling controls will be identified to provide: (1) the ability to make direct comparisons with the survivors, (2) data on outcomes in a non-cancer population, and (3) additional comparison group to determine the consistency of findings between data sources. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival(PFS) | 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 | 5 years | 
| Locoregional failure-free survival(LRFS) | 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 | 5 years | 
| Distant metastasis-free survival(DMFS) | 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 | 5 years | 
| Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) | The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children and adolescents