The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2035-12-31

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.

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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.

Conditions

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NPC Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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NPC survivors

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.

No interventions assigned to this group

Sibling Controls

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.

No interventions assigned to this group

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.