Registry following people with Peutz-Jeghers syndrome in China
Follows people with Peutz-Jeghers syndrome over time to track cancers and other outcomes.
Plain-language title generated from the registry record
Registry title: Chinese Multicenter Registry for Peutz-Jeghers Syndrome
Key facts
- Where
- Beijing, Fuzhou, Guangzhou, Hangzhou, Jinan, Shanghai, and Tianjin, ChinaSee the 9 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with Peutz-Jeghers syndrome, confirmed by clinical signs or a gene test. It is an observational registry at hospitals in China.
- Sex
- All sexes can join.
- Disease stage
- Peutz-Jeghers syndrome confirmed by clinical signs (such as Peutz-Jeghers polyps, skin or mouth pigmentation, family history) or by a confirmed STK11 gene change.
- Biomarker or test result
- A confirmed disease-causing or likely disease-causing STK11 gene change counts as a gene-based diagnosis. A variant of uncertain significance alone is not enough.
Main reasons for not taking part
- The diagnosis cannot be confirmed by clinical signs or by a gene test
- No valid written consent for the main registry
- No way to be contacted or followed over time within the consent
Read by machine on 9 November 2026.
Where in China
- Peking University Third HospitalBeijing, ChinaNo longer taking part
- Fujian Maternity and Child Health Care HospitalFuzhou, ChinaNo longer taking part
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- First People's Hospital of HangzhouHangzhou, ChinaNo longer taking part
- Zhejiang Cancer HospitalHangzhou, ChinaNo longer taking part
- Qilu Hospital of Shandong UniversityJinan, ChinaNo longer taking part
- Fudan University Shanghai Cancer CenterShanghai, ChinaNo longer taking part
- Obstetrics&Gynecology Hospital of Fudan UniversityShanghai, ChinaNo longer taking part
- The Second Hospital of Tianjin Medical UniversityTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First People's Hospital of Hangzhou
- Trial code
- NCT07889596
- Record updated
- 29 October 2026
- Original description
This prospective, observational patient registry will enroll approximately 1,000 individuals with a clinical or molecular diagnosis of Peutz-Jeghers syndrome (PJS) at participating hospitals in China. The registry will collect standardized clinical information, existing genetic test reports, family history, and longitudinal outcomes. The primary objective is to estimate the 10-year cumulative incidence of a first invasive malignancy after enrollment among participants without a previous malignancy or an unresolved suspected malignancy at baseline, accounting for death as a competing event. Secondary objectives address organ-specific malignancies, new primary cancers in participants with a cancer history, mortality, major polyp-related complications, and clinical and STK11 variant characteristics. Participants may be followed for up to 20 years. Biospecimen donation, additional baseline sampling, research sequencing, and patient-derived organoid studies are optional and require the corresponding consent. Refusal of an optional component does not preclude participation in the clinical registry. No treatment or clinical surveillance strategy is assigned by the study.Read full original descriptionShow less
Chinese Multicenter Registry for Peutz-Jeghers Syndrome
This prospective, observational patient registry will enroll approximately 1,000 individuals with a clinical or molecular diagnosis of Peutz-Jeghers syndrome (PJS) at participating hospitals in China. The registry will collect standardized clinical information, existing genetic test reports, family history, and longitudinal outcomes. The primary objective is to estimate the 10-year cumulative incidence of a first invasive malignancy after enrollment among participants without a previous malignancy or an unresolved suspected malignancy at baseline, accounting for death as a competing event. Secondary objectives address organ-specific malignancies, new primary cancers in participants with a cancer history, mortality, major polyp-related complications, and clinical and STK11 variant characteristics. Participants may be followed for up to 20 years. Biospecimen donation, additional baseline sampling, research sequencing, and patient-derived organoid studies are optional and require the corresponding consent. Refusal of an optional component does not preclude participation in the clinical registry. No treatment or clinical surveillance strategy is assigned by the study.
Inclusion: A clinical diagnosis of PJS meeting at least one of the following: two or more histologically confirmed Peutz-Jeghers polyps; any number of Peutz-Jeghers polyps and a family history of PJS; characteristic mucocutaneous pigmentation and a family history of PJS; or any number of Peutz-Jeghers polyps together with characteristic mucocutaneous pigmentation. Alternatively, a molecular diagnosis established by a confirmed germline pathogenic or likely pathogenic STK11 variant associated with PJS, interpreted by appropriately qualified professionals; Valid written informed consent for the core clinical registry from the participant or the legally appropriate guardian, with age- and capacity-appropriate information and assent when applicable; Minimum clinical or genetic documentation sufficient to confirm eligibility and agreement to at least one feasible method of longitudinal contact or record-based follow-up within the approved consent; Biospecimen donation, availability of all specimen types, and participation in research sequencing or organoid experiments are not required for clinical registry enrollment.
Exclusion: Neither the clinical nor molecular diagnostic pathway can be confirmed. A variant of uncertain significance alone does not satisfy molecular eligibility; Absence of valid consent for the core registry. Duplicate records of the same individual will be merged rather than counted as additional participants. Inability or refusal to undergo an optional sample procedure is not a registry exclusion criterion. Procedure-specific safety restrictions affect that procedure only.