NCT04094545

Brief Summary

This study investigated the correlation between the changes in the intestinal flora and NPC by an examination of the intestinal flora and multiple clinical indicators of the blood of 8 carefully screened patients of familial NPC, 24 patients of sporadic NPC and 27 healthy controls and a comparison of the differences in their intestinal flora structures and biological functions. By analyzing the function of the intestinal floras of NPC patients, we aimed to provide a better biological marker for patients with familial and sporadic NPC and constructed a disease prediction model for high-risk populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
568

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

September 17, 2019

Last Update Submit

September 17, 2019

Conditions

Keywords

Biomarkernasopharyngeal carcinomafamilialsporadicintestinal flora

Outcome Measures

Primary Outcomes (2)

  • family NPC patients

    NPC patients with a first degree NPC family history

    through study completion, an average of 1 year

  • sporadic NPC patients

    NPC patients without any tumor family history

    through study completion, an average of 1 year

Study Arms (2)

Nasopharyngeal carcinoma(NPC)

The patients (1) were diagnosed with NPC; 2)18\< Age \<75.

Health adults

(1) 18\< Age \<75, and Han Chinese residents living in Hunan more than 3 years. (2) Health examination population who physical examination, assistant examination and serological examination were normal; None of the patients had rhinitis or used any antibiotics during the three months last 3 months.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We recruited 481 NPC patients and staged their tumor status with the AJCC 7th edition staging criteria,at the same time, 87 healthy volunteers were recruited.

You may qualify if:

  • NPC patients with a first degree family history of NPC
  • NPC patients without any kind of tumor family history

You may not qualify if:

  • Informed refusal.
  • Lack of necessary tests and patient test information is not detailed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Xiangya Hospital of Central South University

Changsha, Hunan, 410006, China

Location

Related Publications (8)

  • Bei JX, Li Y, Jia WH, Feng BJ, Zhou G, Chen LZ, Feng QS, Low HQ, Zhang H, He F, Tai ES, Kang T, Liu ET, Liu J, Zeng YX. A genome-wide association study of nasopharyngeal carcinoma identifies three new susceptibility loci. Nat Genet. 2010 Jul;42(7):599-603. doi: 10.1038/ng.601. Epub 2010 May 30.

  • Bhatt AP, Redinbo MR, Bultman SJ. The role of the microbiome in cancer development and therapy. CA Cancer J Clin. 2017 Jul 8;67(4):326-344. doi: 10.3322/caac.21398. Epub 2017 May 8.

  • Bokulich NA, Kaehler BD, Rideout JR, Dillon M, Bolyen E, Knight R, Huttley GA, Gregory Caporaso J. Optimizing taxonomic classification of marker-gene amplicon sequences with QIIME 2's q2-feature-classifier plugin. Microbiome. 2018 May 17;6(1):90. doi: 10.1186/s40168-018-0470-z.

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  • Chung H, Pamp SJ, Hill JA, Surana NK, Edelman SM, Troy EB, Reading NC, Villablanca EJ, Wang S, Mora JR, Umesaki Y, Mathis D, Benoist C, Relman DA, Kasper DL. Gut immune maturation depends on colonization with a host-specific microbiota. Cell. 2012 Jun 22;149(7):1578-93. doi: 10.1016/j.cell.2012.04.037.

  • Escobar JS, Klotz B, Valdes BE, Agudelo GM. The gut microbiota of Colombians differs from that of Americans, Europeans and Asians. BMC Microbiol. 2014 Dec 14;14:311. doi: 10.1186/s12866-014-0311-6.

  • Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Pineros M, Znaor A, Bray F. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2019 Apr 15;144(8):1941-1953. doi: 10.1002/ijc.31937. Epub 2018 Dec 6.

  • Goodrich JK, Waters JL, Poole AC, Sutter JL, Koren O, Blekhman R, Beaumont M, Van Treuren W, Knight R, Bell JT, Spector TD, Clark AG, Ley RE. Human genetics shape the gut microbiome. Cell. 2014 Nov 6;159(4):789-99. doi: 10.1016/j.cell.2014.09.053.

Biospecimen

Retention: SAMPLES WITH DNA

The faeces and the sera of the recruited participants

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

August 1, 2018

Primary Completion

December 31, 2018

Study Completion

May 30, 2019

Last Updated

September 19, 2019

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations