NCT03637634|Not Yet Recruiting
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
CANPCSS
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CANPCSS
Sponsor study identifier
observational
1,000
0 countries
N/A
Study Start
September 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2018
Actual (reported)August 20, 2018
Actual (reported)September 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall survival(OS)
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
Progress-free survival(PFS)
5 years
Locoregional failure-free survival(LRFS)
5 years
Distant metastasis-free survival(DMFS)
5 years
Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
3 months
Long-term toxicities
Through study completion, an average of half year
Long-term toxicities
Through study completion, an average of half year
Long-term toxicities
Through study completion, an average of half year
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.
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.
NPC patients under 21 years old and their siblings
Wei WI, Sham JS. Nasopharyngeal carcinoma. Lancet. 2005 Jun 11-17;365(9476):2041-54. doi: 10.1016/S0140-6736(05)66698-6.
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.
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.
Blood, saliva and tumor specimens
Hai Mai, Dr
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
First Submitted
August 3, 2018
First Posted
August 20, 2018
Study Start
September 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2030
Contact the study team to confirm eligibility.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 28, 2018
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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