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Nasopharyngeal CarcinomaNCT04094545

Intestinal Flora Sequencing for Nasopharyngeal Carcinoma

An observational study of Nasopharyngeal Carcinoma, run by The Third Xiangya Hospital of Central South University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Nasopharyngeal Carcinoma
How many people
568 participants
Where
1 siteChina
Study dates
1 Aug 2018to 30 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • the Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410006

Other trials in China

About this study

Official title: Intestinal Flora Disruption and a Novel Intestinal Biomarker Associated With Nasopharyngeal Carcinoma

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.

Read the detailed description

Nasopharyngeal carcinoma (NPC) is a malignant nasopharyngeal disease with a complicated etiology that occurs mostly in southern China. Intestinal flora imbalance is believed to be associated with a variety of organ malignancies. Currently, the relationship between intestinal flora and NPC is not clear, although many studies have shown that intestinal flora can be used as a biomarker for many cancers and to predict cancer.

To compare the differences in intestinal flora compositions and biological functions among patients with familial NPC (NPC_F), patients with sporadic NPC (NPC_S) and healthy controls (NOR), we compared the intestinal flora DNA sequencing and hematological testing results between every two groups using bioinformatic methods.

Keywords
Biomarker, nasopharyngeal carcinoma, familial, sporadic, intestinal flora
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04094545
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. family NPC patients

    NPC patients with a first degree NPC family history

    Measured: through study completion, an average of 1 year

  2. sporadic NPC patients

    NPC patients without any tumor family history

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start1 Aug 2018
  3. Primary completion31 Dec 2018
  4. Study completion30 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04094545
Sponsor's protocol ID
ThirdXiangyaJHY
Status last verified
Sep 2018
First submitted
17 Sep 2019
Last updated
19 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20512145

  • 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.

    PubMed 28481406

  • 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.

    PubMed 29773078

  • 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.

    PubMed 30207593

  • 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.

    PubMed 22726443

  • 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.

    PubMed 25495462

  • 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.

    PubMed 30350310

  • 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.

    PubMed 25417156

Questions about this trial

What is this clinical trial studying?

An observational study of Nasopharyngeal Carcinoma, run by The Third Xiangya Hospital of Central South University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

family NPC patients (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04094545, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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