Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome

January 15, 2019 updated by: Yiqi Du

Molecular Typing and Precise Prevention and Treatment of Peutz-Jeghers Syndrome

The mutation of STK11 has been regcognized to be the major cause of Peutz-Jeghers syndrome (PJS).The aim of this study was to confirm the mutation rate of gene associated with gastrointestinal malignancies,including STK11, APC,PMS1,et al. Furtherly, the investigators analyze the association of STK11 with gut microbiota.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients diagnosed as PJS were enrolled and accepted second generation gene sequencing with their blood specimens. Then all patients allocated into gene mutation group and no gene mutation group according to if the cases accompany with gene mutation of STK11.Also, health persons were enrolled and a case controlled study will be carried out.All patients and health persons accepted 16s rRNA sequencing with their feces specimens.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject with ages from 18-70 years old.
  2. Subject diagnosed with Peutz-Jeughers syndrome.
  3. Subject without hypertension, diabetes and other gastrointestinal diseases.
  4. The consent form has been signed.

Exclusion Criteria:

  1. Subject is younger than 18 years or older than 70 years.
  2. Subject with hypertension,diabetes and other gastrointestinal diseases.
  3. Subject taken or adminstered medicine associated with digestive function during latest 1 month.
  4. Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Peutz-Jeghers patients
All Peutz-Jeghers patients meet the clinical criteria
Behavioral: Second generation sequencing
Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen
Behavioral: 16s rRNA gene sequencing
Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen
PLACEBO_COMPARATOR: Health persons
Those without Peutz-Jeghers syndrome
Behavioral: 16s rRNA gene sequencing
Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mutation of gene associated with Peutz-Jeghers syndrome
Time Frame: 2 years
Mutation of gene associated with Peutz-Jeghers syndrome, including STK11, APC,PMS1,PMS2 et al.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal microbiota of patients with PJS
Time Frame: 1year
Identify the variation of intestinal microbiota of patients with PJS
1year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association of STK11 with intestinal microbiota of patients with PJS
Time Frame: 1 year
The association of STK11 with intestinal microbiota of patients with PJS
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yiqi Du

Investigators

  • Study Chair: Yiqi Du, Ph.D., Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017JZ13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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