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Trial record 2 of 16 for:    "Peutz-Jeghers Syndrome"

Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome

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ClinicalTrials.gov Identifier: NCT03806075
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yiqi Du, Changhai Hospital

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.

Condition or disease Intervention/treatment Phase
Peutz-Jeghers Syndrome Behavioral: Second generation sequencing Behavioral: 16s rRNA gene sequencing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Molecular Typing and Precise Prevention and Treatment of Peutz-Jeghers Syndrome
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Intestinal microbiota of patients with PJS [ Time Frame: 1year ]
    Identify the variation of intestinal microbiota of patients with PJS


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806075


Contacts
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Contact: Yuxin Wang, Ph.D. 86-18721819083 18721819083@163.com

Locations
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China
Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Yuxin Wang, Ph.D.    86-18721819083    18721819083@163.com   
Sponsors and Collaborators
Yiqi Du
Investigators
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Study Chair: Yiqi Du, Ph.D. Changhai Hospital

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Responsible Party: Yiqi Du, Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03806075     History of Changes
Other Study ID Numbers: 2017JZ13
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yiqi Du, Changhai Hospital:
Second generation gene sequencing, gut microbiota, Gastrointestinal polyp syndrome
Additional relevant MeSH terms:
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Peutz-Jeghers Syndrome
Syndrome
Disease
Pathologic Processes
Neoplastic Syndromes, Hereditary
Neoplasms
Intestinal Polyposis
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Lentigo
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases