Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peutz-Jeghers Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Peutz-Jeghers patients

All Peutz-Jeghers patients meet the clinical criteria

Group Type EXPERIMENTAL

Second generation sequencing

Intervention Type BEHAVIORAL

Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen

16s rRNA gene sequencing

Intervention Type BEHAVIORAL

Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen

Health persons

Those without Peutz-Jeghers syndrome

Group Type PLACEBO_COMPARATOR

16s rRNA gene sequencing

Intervention Type BEHAVIORAL

Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen

Interventions

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Second generation sequencing

Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen

Intervention Type BEHAVIORAL

16s rRNA gene sequencing

Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes