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Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome

Primary Purpose

Peutz-Jeghers Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Second generation sequencing
16s rRNA gene sequencing
Sponsored by
Yiqi Du
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peutz-Jeghers Syndrome focused on measuring Second generation gene sequencing, gut microbiota, Gastrointestinal polyp syndrome

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Peutz-Jeghers patients

Health persons

Arm Description

All Peutz-Jeghers patients meet the clinical criteria

Those without Peutz-Jeghers syndrome

Outcomes

Primary Outcome Measures

Mutation of gene associated with Peutz-Jeghers syndrome
Mutation of gene associated with Peutz-Jeghers syndrome, including STK11, APC,PMS1,PMS2 et al.

Secondary Outcome Measures

Intestinal microbiota of patients with PJS
Identify the variation of intestinal microbiota of patients with PJS

Full Information

First Posted
January 13, 2019
Last Updated
January 15, 2019
Sponsor
Yiqi Du
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1. Study Identification

Unique Protocol Identification Number
NCT03806075
Brief Title
Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome
Official Title
Molecular Typing and Precise Prevention and Treatment of Peutz-Jeghers Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yiqi Du

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peutz-Jeghers Syndrome
Keywords
Second generation gene sequencing, gut microbiota, Gastrointestinal polyp syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All patients with Peutz-Jeghers were enrolled and accepted second generation gene sequencing. Then all patients allocated into gene mutation group and no gene mutation group according to if the cases accompany with gene mutation of STK11.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peutz-Jeghers patients
Arm Type
Experimental
Arm Description
All Peutz-Jeghers patients meet the clinical criteria
Arm Title
Health persons
Arm Type
Placebo Comparator
Arm Description
Those without Peutz-Jeghers syndrome
Intervention Type
Behavioral
Intervention Name(s)
Second generation sequencing
Intervention Description
Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen
Intervention Type
Behavioral
Intervention Name(s)
16s rRNA gene sequencing
Intervention Description
Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen
Primary Outcome Measure Information:
Title
Mutation of gene associated with Peutz-Jeghers syndrome
Description
Mutation of gene associated with Peutz-Jeghers syndrome, including STK11, APC,PMS1,PMS2 et al.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Intestinal microbiota of patients with PJS
Description
Identify the variation of intestinal microbiota of patients with PJS
Time Frame
1year
Other Pre-specified Outcome Measures:
Title
The association of STK11 with intestinal microbiota of patients with PJS
Description
The association of STK11 with intestinal microbiota of patients with PJS
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject with ages from 18-70 years old. Subject diagnosed with Peutz-Jeughers syndrome. Subject without hypertension, diabetes and other gastrointestinal diseases. The consent form has been signed. Exclusion Criteria: Subject is younger than 18 years or older than 70 years. Subject with hypertension,diabetes and other gastrointestinal diseases. Subject taken or adminstered medicine associated with digestive function during latest 1 month. Pregnant women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxin Wang, Ph.D.
Phone
86-18721819083
Email
18721819083@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiqi Du, Ph.D.
Organizational Affiliation
Changhai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxin Wang, Ph.D.
Phone
86-18721819083
Email
18721819083@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome

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