The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study (CANPCSS)

Hai-Qiang Mai,MD,PhD

Status: Not yet enrolling

Conditions: NPC Patients

Study type: Observational

Funder types: Other

Identifiers

NCT03637634

Childhood NPC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

NPC survivors

Description:

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

Description:

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.