Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome

Peutz-Jeghers Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03806075
• Other study ID #: 2017JZ13
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: January 2019
• Source: Changhai Hospital
• Contact: Yuxin Wang, Ph.D.
• Phone: 86-18721819083
• Email: 18721819083[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peutz-Jeghers Syndrome
• Syndrome

Intervention

Behavioral:
• Second generation sequencing
Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen
• 16s rRNA gene sequencing
Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Yiqi Du

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The association of STK11 with intestinal microbiota of patients with PJS	The association of STK11 with intestinal microbiota of patients with PJS	1 year
Primary	Mutation of gene associated with Peutz-Jeghers syndrome	Mutation of gene associated with Peutz-Jeghers syndrome, including STK11, APC,PMS1,PMS2 et al.	2 years
Secondary	Intestinal microbiota of patients with PJS	Identify the variation of intestinal microbiota of patients with PJS	1year