The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study (CANPCSS)

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ClinicalTrials.gov Identifier: NCT03637634

Recruitment Status : Not yet recruiting

First Posted : August 20, 2018

Last Update Posted : August 28, 2018

See Contacts and Locations

Sponsor:

Collaborators:

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangdong Provincial People's Hospital

First Affiliated Hospital of Jinan University

Nanfang Hospital of Southern Medical University

Affiliated Cancer Hospital of Shantou University Medical College

Zhanjiang Cancer Hospital

Affiliated Zhongshan Hospital, Sun Yat-Sen University

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

Wuhan Union Hospital, China

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

Beijing Cancer Hospital

Cancer Hospital of Guangxi Medical University

Tongji Hospital

Information provided by (Responsible Party):

Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Study Description

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.

Condition or disease
NPC Patients

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	1000 participants
Observational Model:	Cohort
Time Perspective:	Other
Official Title:	The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
Estimated Study Start Date :	September 1, 2018
Estimated Primary Completion Date :	December 31, 2030
Estimated Study Completion Date :	December 31, 2035

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Nasopharyngeal Carcinoma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.
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.

Outcome Measures

Primary Outcome Measures :

Overall survival(OS) [ Time Frame: 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 Outcome Measures :

Progress-free survival(PFS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 3 months ]
The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

Other Outcome Measures:

Long-term toxicities [ Time Frame: 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)
Long-term toxicities [ Time Frame: Through study completion, an average of half year ]
EORTC quality of life questionnaire(QLQ) Head and Neck
Long-term toxicities [ Time Frame: Through study completion, an average of half year ]
Late Effects Normal Tissue Task Force-Subjective, Objective, Management and Analytic (LENT-SOMA) scoring systems
Growth [ Time Frame: Through study completion, an average of half year ]
Patients will be monitored for height(in metre)
Growth [ Time Frame: Through study completion, an average of half year ]
Patients will be monitored for weight(in kilogram)
Growth [ Time Frame: Through study completion, an average of half year ]
Patients will be monitored for BMI(in kg/m^2)
Sex Development [ Time Frame: Through study completion, an average of half year ]
secondary sex characteristic survey
Sex Development [ Time Frame: Through study completion, an average of half year ]
sex hormone(estrogen,testosterone) levels(in nmol/L).
Intelligence Development [ Time Frame: Through study completion, an average of half year ]
Intelligence quotient by Stanford-Binet test

Biospecimen Retention: Samples With DNA

Blood, saliva and tumor specimens

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

NPC patients under 21 years old and their siblings

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637634

Contacts

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Contact: Haiqiang Mai, Dr	86-20-8734-3643	maihq@mail.sysu.edu.cn

Sponsors and Collaborators

Hai-Qiang Mai,MD,PhD