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Not yet recruiting NCT03637634

The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study

— Observational NPC Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: NPC Patients. Basic parameters: up to 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Overall survival(OS) [Time frame: 5 years]
Secondary outcome measures (4)
  • Progress-free survival(PFS) [Time frame: 5 years]
  • Locoregional failure-free survival(LRFS) [Time frame: 5 years]
  • Distant metastasis-free survival(DMFS) [Time frame: 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Wei WI, Sham JS. Nasopharyngeal carcinoma. Lancet. 2005 Jun 11-17;365(9476):2041-54. doi: 10.1016/S0140-6736(05)66698-6. PMID 15950718
  • 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. PMID 7216543
  • 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. PMID 2120164
  • 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. PMID 19327901

Identifiers

NCT: NCT03637634 · Childhood NPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗