NCT03637634

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Sep 2018

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Sep 2018Dec 2035

First Submitted

Initial submission to the registry

August 3, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

12.3 years

First QC Date

August 3, 2018

Last Update Submit

August 26, 2018

Conditions

NPC Patients

Keywords

children and adolescents

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

Other Outcomes (9)

  • 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

  • +6 more other outcomes

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

NPC patients under 21 years old and their siblings

You may qualify if:

  • 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.

You may not qualify if:

  • Already involved in other blind clinical trial.
  • The information of tumour response evaluation and survival data cannot be obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

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

    PMID: 15950718BACKGROUND

  • 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: 7216543BACKGROUND

  • 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: 2120164BACKGROUND

  • 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: 19327901BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva and tumor specimens

Study Officials

  • Hai Mai, Dr

    Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

    STUDY CHAIR

Central Study Contacts

Haiqiang Mai, Dr

CONTACT

86-20-8734-3643maihq@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hai-Qiang Mai

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 20, 2018

Study Start

September 1, 2018

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Last Updated

August 28, 2018

Record last verified: 2018-08