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Immune Repertoire Decoding for Chronic Pancreatitis-to-Pancreatic Cancer Risk Stratification

21. května 2026 aktualizováno: Zhuan Liao, Changhai Hospital

Immune Repertoire Decoding Enables Dynamic Risk Stratification During Chronic Pancreatitis-to-Pancreatic Cancer Transition

This study will follow people with chronic pancreatitis, people with pancreatic cancer, and healthy volunteers. The goal is to better understand why some people with chronic pancreatitis may later develop pancreatic cancer.

Participants will provide blood samples and health information. Some participants may also provide tissue samples if these are available during routine medical care. The study team will look for changes in the immune system, genes, medical images, and clinical information that may be linked to the development of pancreatic cancer.

People with chronic pancreatitis will be followed over time. The information collected in this study may help researchers develop a model to identify patients with chronic pancreatitis who have a higher risk of pancreatic cancer.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Detailní popis

Chronic pancreatitis is considered an important precancerous condition for pancreatic ductal adenocarcinoma, but the immune changes associated with malignant transformation remain incompletely understood. This prospective observational cohort study will enroll healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma at Changhai Hospital.

The study will collect standardized clinical information, laboratory data, abdominal CT or MRI imaging data, peripheral blood samples, and, when available, tissue samples. Peripheral blood samples will be used for immune repertoire profiling, including T-cell receptor and B-cell receptor sequencing. Additional analyses may include antibody repertoire profiling, germline genetic testing, single-cell sequencing, spatial transcriptomics, and multiplex immunofluorescence in selected representative cases.

Patients with chronic pancreatitis will undergo longitudinal follow-up approximately every 6 to 12 months. The study will compare immune repertoire features across healthy controls, chronic pancreatitis, and pancreatic ductal adenocarcinoma, and will evaluate dynamic immune changes during disease progression. The collected immune, genetic, imaging, and clinical data will be integrated to develop and validate an artificial intelligence-based risk stratification model for identifying patients with chronic pancreatitis who may be at increased risk of pancreatic cancer. Participant enrollment and baseline sample collection are planned to be completed by June 2028. Follow-up, data processing, model development, and final data collection are planned to continue through December 2028.

Typ studie

Pozorovací

Zápis (Odhadovaný)

800

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Zhuan Liao, PhD
  • Telefonní číslo: +86-21-31161001
  • E-mail: zhuanleo@126.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Participants will be selected from healthy volunteers and patients receiving care at Changhai Hospital. The study population will include healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma. Patients with chronic pancreatitis and pancreatic ductal adenocarcinoma will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Healthy volunteers will be recruited as a reference cohort.

Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.

Popis

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Able to understand the study procedures and provide written informed consent.
  • Healthy controls: participants without a known history of chronic pancreatitis or pancreatic cancer.
  • Chronic pancreatitis cohort: participants diagnosed with chronic pancreatitis according to clinical guidelines, based on clinical, imaging, and/or genetic information.
  • Pancreatic ductal adenocarcinoma cohort: participants with newly diagnosed pancreatic ductal adenocarcinoma based on clinical, imaging, and/or pathological evaluation.
  • Willing to provide blood samples and relevant clinical information.
  • For participants with chronic pancreatitis, willing to undergo longitudinal follow-up approximately every 6 to 12 months.

Exclusion Criteria:

  • Unable or unwilling to provide written informed consent.
  • Unable to provide required clinical information or biological samples.
  • Prior diagnosis of another active malignant tumor, except adequately treated non-melanoma skin cancer or carcinoma in situ, if considered not to affect study participation by the investigator.
  • Current severe acute infection or other serious medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of immune-related analyses.
  • Use of systemic immunosuppressive therapy or immunotherapy within a period considered clinically relevant by the investigator.
  • Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Healthy Controls
Healthy volunteers without chronic pancreatitis or pancreatic cancer will be enrolled as the reference cohort for comparison with the chronic pancreatitis and pancreatic ductal adenocarcinoma cohorts.
Chronic Pancreatitis
Participants with chronic pancreatitis will be enrolled as the main longitudinal cohort. This cohort will be followed over time to evaluate clinical, imaging, genetic, and immune features associated with pancreatic cancer risk.
Pancreatic Ductal Adenocarcinoma
Participants with newly diagnosed pancreatic ductal adenocarcinoma will be enrolled as the pancreatic cancer cohort for comparison with the healthy control and chronic pancreatitis cohorts.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Peripheral Blood TCR/BCR Immune Repertoire Features Over 30 Months
Časové okno: Baseline and every 6 to 12 months for up to 30 months after enrollment
Peripheral blood T-cell receptor and B-cell receptor immune repertoire features will be measured from blood samples. Features will include clonotype diversity, clonal expansion, V/J gene usage, CDR3 sequence characteristics, B-cell receptor somatic hypermutation, and shared immune clonotype clusters. These features will be compared across healthy controls, participants with chronic pancreatitis, and participants with pancreatic ductal adenocarcinoma, and longitudinal changes will be evaluated in participants with chronic pancreatitis.
Baseline and every 6 to 12 months for up to 30 months after enrollment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Performance of a Multimodal Risk Stratification Model for Pancreatic Cancer in Chronic Pancreatitis
Časové okno: Baseline and follow-up data collected up to 30 months after enrollment
A risk stratification model will be developed using immune repertoire, germline genetic, imaging, and clinical features to identify participants with chronic pancreatitis who may be at increased risk of pancreatic cancer. Model performance will be assessed using discrimination, calibration, sensitivity, specificity, and other predictive performance measures.
Baseline and follow-up data collected up to 30 months after enrollment
Number of Participants With Chronic Pancreatitis Who Develop Pancreatic Ductal Adenocarcinoma
Časové okno: From enrollment to the last scheduled follow-up, up to 30 months
The number of participants with chronic pancreatitis who develop pancreatic ductal adenocarcinoma during follow-up will be recorded. The diagnosis will be based on clinical evaluation, imaging findings, pathology when available, and follow-up information.
From enrollment to the last scheduled follow-up, up to 30 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Changhai Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Zhuan Liao, PhD, Changhai Hospital, Naval Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

21. května 2026

První předloženo, které splnilo kritéria kontroly kvality

21. května 2026

První zveřejněno (Aktuální)

28. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CHEC2026-120
  • 82541011 (Jiné číslo grantu/financování: National Natural Science Foundation of China)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified individual participant data underlying the main study results may be shared under controlled access. Shared data may include de-identified demographic and clinical data, laboratory results, imaging-related data or metadata, germline genetic testing results, immune repertoire-derived data, and longitudinal follow-up outcomes. Data will be shared together with relevant metadata or a data dictionary when permitted by the ethics approval, informed consent, and institutional data-sharing policies.

Časový rámec sdílení IPD

Beginning 12 months after publication of the main study results and available for 5 years.

Kritéria přístupu pro sdílení IPD

Researchers with a scientifically sound proposal may submit a data access request to the study investigators or the designated data management platform. Requests will be reviewed for scientific purpose, ethical approval, data security, and consistency with the informed consent and institutional policies. Data will be shared only after approval and, when required, completion of a data use agreement.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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