The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study (CANPCSS)

August 26, 2018 updated by: Hai-Qiang Mai,MD,PhD
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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NPC patients under 21 years old and their siblings

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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
5 years
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
5 years
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)
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Through study completion, an average of half year
Long-term toxicities
Time Frame: Through study completion, an average of half year
EORTC quality of life questionnaire(QLQ) Head and Neck
Through study completion, an average of half year
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
Through study completion, an average of half year
Growth
Time Frame: Through study completion, an average of half year
Patients will be monitored for height(in metre)
Through study completion, an average of half year
Growth
Time Frame: Through study completion, an average of half year
Patients will be monitored for weight(in kilogram)
Through study completion, an average of half year
Growth
Time Frame: Through study completion, an average of half year
Patients will be monitored for BMI(in kg/m^2)
Through study completion, an average of half year
Sex Development
Time Frame: Through study completion, an average of half year
secondary sex characteristic survey
Through study completion, an average of half year
Sex Development
Time Frame: Through study completion, an average of half year
sex hormone(estrogen,testosterone) levels(in nmol/L).
Through study completion, an average of half year
Intelligence Development
Time Frame: Through study completion, an average of half year
Intelligence quotient by Stanford-Binet test
Through study completion, an average of half year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hai-Qiang Mai,MD,PhD

Collaborators

Zhejiang Cancer Hospital
Fudan University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Fujian Cancer Hospital
Tongji Hospital
Hunan Cancer Hospital
Peking University Cancer Hospital & Institute
Nanfang Hospital of Southern Medical University
Shandong Cancer Hospital and Institute
The First Affiliated Hospital of Zhengzhou University
Jiangxi Provincial Cancer Hospital
Guangdong Provincial People's Hospital
Jiangsu Cancer Institute & Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
First Affiliated Hospital of Jinan University
Affiliated Cancer Hospital of Shantou University Medical College
First People's Hospital of Foshan
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Shenzhen Second People's Hospital
Dongguan People's Hospital
Second Affiliated Hospital of Nanchang University
Sichuan Cancer Hospital and Research Institute
Cancer Hospital of Guangxi Medical University
Yuebei People's Hospital
Jiangmen Central Hospital
Cancer Hospital of Guizhou Province
Zhanjiang Cancer Hospital
Affiliated Zhongshan Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Hai Mai, Dr, Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2030

Study Completion (ANTICIPATED)

December 31, 2035

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 26, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Childhood NPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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