NPC Patients
Conditions
Keywords
children and adolescents
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.
Interventions
None listed
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangdong Provincial People's Hospital
First Affiliated Hospital of Jinan University
Nanfang Hospital, Southern Medical University
Affiliated Cancer Hospital of Shantou University Medical College
Zhanjiang Cancer Hospital
Zhongnan Hospital
First People's Hospital of Foshan
Dongguan People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Shenzhen Second People's Hospital
Jiangmen Central Hospital
Yuebei People's Hospital
Hunan Cancer Hospital
Cancer Hospital of Guizhou Province
Fudan University
Fujian Cancer Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Zhengzhou University
Zhejiang Cancer Hospital
Sichuan Cancer Hospital and Research Institute
Shandong Cancer Hospital and Institute
Jiangsu Cancer Institute & Hospital
Jiangxi Provincial Cancer Hospital
Second Affiliated Hospital of Nanchang University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking University Cancer Hospital & Institute
Cancer Hospital of Guangxi Medical University
Tongji Hospital
Hai-Qiang Mai,MD,PhD
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Growth | Through study completion, an average of half year | Patients will be monitored for height(in metre) |
| Sex Development | Through study completion, an average of half year | secondary sex characteristic survey |
| Intelligence Development | Through study completion, an average of half year | Intelligence quotient by Stanford-Binet test |
| Long-term toxicities | Through study completion, an average of half year | QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) |
Contacts
Primary ContactHaiqiang Mai, Dr
Outcome results
None listed