Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03637634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2018-08-28
First Post:
2018-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
Sponsor:
Hai-Qiang Mai,MD,PhD
Organization:
Study Overview
Official Title:
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CANPCSS
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.
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.
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: