Clinical Trials Logo

Clinical Trial Summary

In an effort to identify genetic factors linked to the development of nasopharyngeal cancer (NPC), the researchers identified and sampled 2,394 individuals from Taiwanese families in which two or more relatives had been diagnosed with NPC. Serum from these individuals was tested for three anti-Epstein-Barr virus (EPV) antibodies associated with elevated risk of NPC. Results indicate that apparently healthy individuals from high-risk families have a nearly threefold elevation in their EBV antibody prevalence compared with the general population. However, the clinical implications of this finding are not yet understood.

To clarify the implications, the 2,394 unaffected individuals from the multiplex family study will be invited to participate in the current study. Approximately 1,600 individuals are expected to participate.

Participants will have an ear, nose, and throat examination to determine if they have occult or symptomatic NPC. Their levels of EBV antibody at the time of initial recruitment will be correlated with NPC detection in the period between initial recruitment and the present study. Participants will also be asked to complete a brief risk factor questionnaire and to donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future studies.

Currently, no accepted clinical management protocol exists for screening unaffected members from families at high risk of NPC development. Results from this study have the potential to significantly impact the clinical management and follow-up of individuals with a family history of NPC.


Clinical Trial Description

The purpose of this proposed study is to evaluate the clinical utility of serum EBV antibody testing for the identification of individuals at increased risk of nasopharyngeal carcinoma (NPC) within high-risk, NPC multiplex families.

2,394 unaffected individuals from Taiwanese families, in which two or more relatives have been diagnosed with NPC, have been identified and sampled as part of an ongoing collaboration to identify genetic factors linked to NPC development. Serum from these individuals has been tested for three anti-EBV antibodies (VCA IgA, EBNA1 IgA, and anti-DNase) known to be associated with elevated risk of prevalent and incident NPC in general population studies. Results from testing of our study population indicate that apparently healthy individuals from high-risk multiplex families have a near 3-fold elevation in their EBV antibody prevalence when compared to the EBV antibody prevalence observed in the general community for these same EBV markers. However, the clinical implications of this apparent elevation in EBV antibody reactivity are not yet understood.

Therefore, we propose to evaluate whether individuals within our previously conducted high-risk family study with elevations in EBV antibody levels are at increased risk of incident NPC. Individual markers (VCA IgA, EBNIA1 IgA and anti-DNase antibodies) and combinations of markers will be evaluated to determine their performance as screening tests for NPC risk in high-risk multiplex families.

To achieve this goal, we propose to invite the 2,394 unaffected individuals from our multiplex family study, defined as those families with greater than or equal to 2 NPC. As a result of our recruitment efforts, we expect approximately 1,600 subjects to participate in an ear, nose, and throat (ENT) examination by an expert otolaryngologist to determine whether any of these individuals has occult or symptomatic NPC. We will correlate the three EBV antibody screening tests performed at the time of initial recruitment into our family study with NPC detection in the period between initial recruitment into the family study and the present study (median time between original EBV antibody testing and clinical evaluation = 5.5 years; range = less than 1 year - 10 years).

In addition to histopathological specimens collected for NPC diagnosis, participants in this study will be asked to agree to a brief risk factor questionnaire and to donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future studies.

No accepted clinical management protocol exists for screening unaffected members from families at high-risk of NPC development. Results from this study have the potential to significantly impact the clinical management and follow-up of individuals with a family history of NPC. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00393224
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Terminated
Phase
Start date July 5, 2005
Completion date June 2, 2020

See also
  Status Clinical Trial Phase
Completed NCT01256853 - Modified Vaccinia Ankara (MVA) Vaccine Study Phase 1
Not yet recruiting NCT00577057 - Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer N/A
Recruiting NCT02945878 - Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma N/A
Terminated NCT02874651 - ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy Phase 2
Not yet recruiting NCT05807880 - Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Completed NCT00342147 - Family Study of Head and Neck Cancers in Taiwan
Recruiting NCT02980315 - A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application Phase 1/Phase 2
Active, not recruiting NCT01735409 - Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma Phase 1/Phase 2
Completed NCT00565448 - Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents Phase 2
Completed NCT00630149 - Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy Phase 2
Active, not recruiting NCT03854838 - IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma. Phase 2
Completed NCT01797900 - The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT Phase 2
Completed NCT00436800 - Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma Phase 2
Active, not recruiting NCT00563927 - Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0) N/A
Not yet recruiting NCT04870905 - Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma Phase 2
Active, not recruiting NCT02902432 - A Trial of Endostar in Patients With Carcinoma of the Head and Neck Phase 2
Active, not recruiting NCT02456506 - Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma. N/A
Completed NCT02444949 - A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma Phase 2
Completed NCT00188877 - Intensity Modulated Radiation Therapy for Head and Neck Cancer Phase 2
Not yet recruiting NCT03093649 - Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma N/A