Clinical trial NCT03637634: The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
Official title: The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NPC Patients
Keywords: children and adolescents
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Guangdong Provincial People's Hospital
name: First Affiliated Hospital of Jinan University
name: Nanfang Hospital, Southern Medical University
name: Affiliated Cancer Hospital of Shantou University Medical College
name: Zhanjiang Cancer Hospital
name: Zhongnan Hospital
name: First People's Hospital of Foshan
name: Dongguan People's Hospital
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Shenzhen Second People's Hospital
name: Jiangmen Central Hospital
name: Yuebei People's Hospital
name: Hunan Cancer Hospital
name: Cancer Hospital of Guizhou Province
name: Fudan University
name: Fujian Cancer Hospital
name: Wuhan Union Hospital, China
name: The First Affiliated Hospital of Zhengzhou University
name: Zhejiang Cancer Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Shandong Cancer Hospital and Institute
name: Jiangsu Cancer Institute & Hospital
name: Jiangxi Provincial Cancer Hospital
name: Second Affiliated Hospital of Nanchang University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Peking University Cancer Hospital & Institute
name: Cancer Hospital of Guangxi Medical University
name: Tongji Hospital
First posted: 2018-08-20
Enrollment: 1000
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NPC patients under 21 years old and their siblings

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival(OS)
timeFrame: 5 years
Secondary outcomes:
measure: Progress-free survival(PFS)
timeFrame: 5 years
measure: Locoregional failure-free survival(LRFS)
timeFrame: 5 years
measure: Distant metastasis-free survival(DMFS)
timeFrame: 5 years
measure: Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
timeFrame: 3 months
Other outcomes:
measure: Long-term toxicities
timeFrame: Through study completion, an average of half year
measure: Long-term toxicities
timeFrame: Through study completion, an average of half year
measure: Long-term toxicities
timeFrame: Through study completion, an average of half year
measure: Growth
timeFrame: Through study completion, an average of half year
measure: Growth
timeFrame: Through study completion, an average of half year
measure: Growth
timeFrame: Through study completion, an average of half year
measure: Sex Development
timeFrame: Through study completion, an average of half year
measure: Sex Development
timeFrame: Through study completion, an average of half year
measure: Intelligence Development
timeFrame: Through study completion, an average of half year
Locations:
Study officials:
affiliation: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
name: Hai Mai, Dr
role: STUDY_CHAIR
References:
citation: Wei WI, Sham JS. Nasopharyngeal carcinoma. Lancet. 2005 Jun 11-17;365(9476):2041-54. doi: 10.1016/S0140-6736(05)66698-6.
citation: Levine PH, Connelly RR, Easton JM. Demographic patterns for nasopharyngeal carcinoma in the United States. Int J Cancer. 1980 Dec 15;26(6):741-8. doi: 10.1002/ijc.2910260607.
citation: Ingersoll L, Woo SY, Donaldson S, Giesler J, Maor MH, Goffinet D, Cangir A, Goepfert H, Oswald MJ, Peters LJ. Nasopharyngeal carcinoma in the young: a combined M.D. Anderson and Stanford experience. Int J Radiat Oncol Biol Phys. 1990 Oct;19(4):881-7. doi: 10.1016/0360-3016(90)90008-8.
citation: Downing NL, Wolden S, Wong P, Petrik DW, Hara W, Le QT. Comparison of treatment results between adult and juvenile nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1064-70. doi: 10.1016/j.ijrobp.2008.12.030. Epub 2009 Mar 26.