Peutz-Jeghers SyndromeNCT03806075
Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome
A study testing Second generation sequencing and 16s rRNA gene sequencing in people with Peutz-Jeghers Syndrome, run by Yiqi Du at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 5 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peutz-Jeghers Syndrome
- What is being tested?
- Second generation sequencing and 16s rRNA gene sequencing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
Yuxin Wang, Ph.D., 86-18721819083, 18721819083@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Peutz-Jeghers Syndrome
- Being tested
- Second generation sequencing, 16s rRNA gene sequencing
- Keywords
- Second generation gene sequencing, gut microbiota, Gastrointestinal polyp syndrome
- Medical subject headings
- Peutz-Jeghers Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second generation sequencingBehavioural
Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen
16s rRNA gene sequencingBehavioural
Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen
| Study group | Role | What they receive |
|---|---|---|
| Peutz-Jeghers patients | Experimental | All Peutz-Jeghers patients meet the clinical criteria Receives: Behavioral: Second generation sequencing; Behavioral: 16s rRNA gene sequencing |
| Health persons | Placebo comparator | Those without Peutz-Jeghers syndrome Receives: Behavioral: 16s rRNA gene sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutation of gene associated with Peutz-Jeghers syndrome
Mutation of gene associated with Peutz-Jeghers syndrome, including STK11, APC,PMS1,PMS2 et al.
Measured: 2 years
Secondary outcomes (1)
Intestinal microbiota of patients with PJS
Identify the variation of intestinal microbiota of patients with PJS
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Mar 2018
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peutz-Jeghers SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yiqi Du
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yiqi Du, Changhai Hospital
- Investigators
- Yiqi Du, Ph.D., Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806075
- Sponsor's protocol ID
- 2017JZ13
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Typing and Precise Prevention and Treatment of Peutz-Jeghers Syndrome
- ClinicalTrials.gov ID
- NCT03806075
- Acronym / sponsor ID
- 2017JZ13
- Conditions
- Peutz-Jeghers Syndrome
- Keywords
- Second generation gene sequencing, gut microbiota, Gastrointestinal polyp syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yiqi DuUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Peutz-Jeghers patients | Experimental | Behavioral: Second generation sequencing, Behavioral: 16s rRNA gene sequencingAll Peutz-Jeghers patients meet the clinical criteria |
| Health persons | Placebo comparator | Behavioral: 16s rRNA gene sequencingThose without Peutz-Jeghers syndrome |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Second generation sequencingFirstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen | Behavioural | Peutz-Jeghers patients |
| 16s rRNA gene sequencingSecondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen | Behavioural | Health persons, Peutz-Jeghers patients |
Primary outcome
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.
1 secondary outcome
Intestinal microbiota of patients with PJS
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Peutz-Jeghers Syndrome
Not yet recruitingObservational study
Chinese Multicenter Registry for Peutz-Jeghers Syndrome
Peutz-Jeghers Syndrome
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
Active, not recruitingObservational study
The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Pancreatic Ductal Adenocarcinoma, Pancreatic Cyst
RecruitingObservational study
Familial Investigations of Childhood Cancer Predisposition
Acute Leukemia, Adenomatous Polyposis
RecruitingObservational study
Pancreas Registry and High Risk Registry
Pancreas Cancer, Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiqi Du, Ph.D. study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second generation sequencing and 16s rRNA gene sequencing in people with Peutz-Jeghers Syndrome, run by Yiqi Du at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxin Wang, Ph.D. (86-18721819083, 18721819083@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutation of gene associated with Peutz-Jeghers syndrome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.